Generated Narrative: Composition 5dfbbf17-05c0-441d-af66-7a66072f4ae4 Profile: eCTD Product Description and Composition status: Final type: m3.2.p.1 description and composition of the drug product date: 2023-12-09 07:12:23+0000 author: Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000 title: eCTD Product Description and Composition for Example1Drug
m3.2.p.1 description and composition of the drug product
eCTD Product Description and Composition for Example1Drug
Container Closure Description for Example1Drug
Generated Narrative: PackagedProductDefinition 77ad6922-9c59-43d1-93cb-29d063cc2e8c Profile: ContainerClosure packageFor: Bundle: identifier = UUID:8a5a9684-f8fb-4f21-a397-a1a0996b2b7f; type = document; timestamp = 2023-12-09 07:12:23+0000 description: Plastic Bottle made of high-density polyethylene (HDPE). The plastic is chosen for its resistance to moisture and its ability to maintain the integrity of the drug. Child-Resistant Cap: The cap features a Push-and-Turn Cap that he user to push down on the cap while turning it, which is difficult for children but manageable for adults. attachedDocument: Bundle: identifier = UUID:8a5a9684-f8fb-4f21-a397-a1a0996b2b7f; type = document; timestamp = 2023-12-09 07:12:23+0000 Packagings - Type * BOTTLE
Plastic Bottle made of high-density polyethylene (HDPE). The plastic is chosen for its resistance to moisture and its ability to maintain the integrity of the drug. Child-Resistant Cap: The cap features a Push-and-Turn Cap that he user to push down on the cap while turning it, which is difficult for children but manageable for adults.
Generated Narrative: MedicinalProductDefinition 5772a6f2-cde1-4903-bfcf-1639340205cc Profile: Drug Product Description description: A tablet consisting of two layers where one provides immediate release and of the two drugs (Figure in 3.2.P.1.3). Both immediate-release layers are composed of granules with a matrix layer for the modified release of the drug. combinedPharmaceuticalDoseForm: TABLET, MULTILAYER route: ORAL name productName: ASPIRIN 200mg, ACETAMINOPHEN 300mg type: Non-Proprietary part part: ASPIRIN type: scientific name part part: 200mg type: ASPIRIN part part: ACETAMINOPHEN type: scientific name part part: 300mg type: ACETAMINOPHEN
A tablet consisting of two layers where one provides immediate release and of the two drugs (Figure in 3.2.P.1.3). Both immediate-release layers are composed of granules with a matrix layer for the modified release of the drug.
Generated Narrative: ManufacturedItemDefinition a8316fc9-8ca8-4115-81c1-9f8f84c99149 Profile: Manufactured Drug Product identifier: Example1Drug status: Draft manufacturedDoseForm: Tablet property type: Product Overall Release Profile value: Extended-Release Profile property type: Product Schematic value: image/png: [binary] property type: Product Weight Type value: Mass property type: Product Total Weight Numeric Numerator value: 1201 milligram (Details: UCUM codemg = 'mg') property type: Quality Standard value: USP-NF property type: Sterile Product Indicator value: true property type: Product Overall Release Mechanism value: Matrix property type: Coating Indicator value: false property type: Tablet Layer Count value: 2 1 (Details: UCUM code1 = '1') property type: Tablet Bead Type Count value: 0 1 (Details: UCUM code1 = '1') property type: Product Total Weight Numeric Denominator value: 1 1* (Details: UCUM code1 = '1') component type: Layer amount: 463 milligram (Details: UCUM codemg = 'mg'), 38.55 percent (Details: UCUM code% = '%') constituent amount: 200 milligram (Details: UCUM codemg = 'mg'), 43.19 percent (Details: UCUM code% = '%') location: Purple Layer function: Active Ingredient HasIngredients - Reference * Bundle: identifier = UUID:8a5a9684-f8fb-4f21-a397-a1a0996b2b7f; type = document; timestamp = 2023-12-09 07:12:23+0000 constituent amount: 262 milligram (Details: UCUM codemg = 'mg'), 56.59 percent (Details: UCUM code% = '%') location: Purple Layer function: Inactive Ingredient, Filler HasIngredients - Reference * Bundle: identifier = UUID:8a5a9684-f8fb-4f21-a397-a1a0996b2b7f; type = document; timestamp = 2023-12-09 07:12:23+0000 constituent amount: 1 milligram (Details: UCUM codemg = 'mg'), 0.22 percent (Details: UCUM code% = '%') location: Purple Layer function: Inactive Ingredient, Coloring Agent HasIngredients - Reference * Bundle: identifier = UUID:8a5a9684-f8fb-4f21-a397-a1a0996b2b7f; type = document; timestamp = 2023-12-09 07:12:23+0000 Properties - Type Value[x] * Product Part Identifier Example1Drug_LayerA * Product Part Release Profile Delayed-Release Profile * Product Part Color Description Purple component Amount Ratio: 738 milligram (Details: UCUM codemg = 'mg')/1 arbitrary unit (Details: UCUM code[arb'U] = '[arb'U]') type: Layer amount: 61.45 percent (Details: UCUM code% = '%') constituent amount: 300 milligram (Details: UCUM codemg = 'mg'), 40.65 percent (Details: UCUM code% = '%') location: White Layer function: Active Ingredient HasIngredients - Reference * Bundle: identifier = UUID:8a5a9684-f8fb-4f21-a397-a1a0996b2b7f; type = document; timestamp = 2023-12-09 07:12:23+0000 constituent amount: 438 milligram (Details: UCUM codemg = 'mg'), 59.35 percent (Details: UCUM code% = '%') location: White Layer function: Inactive Ingredient, Filler HasIngredients - Reference * Bundle: identifier = UUID:8a5a9684-f8fb-4f21-a397-a1a0996b2b7f; type = document; timestamp = 2023-12-09 07:12:23+0000 Properties - Type Value[x] * Product Part Identifier Example1Drug_LayerB * Product Part Release Profile Delayed-Release Profile * Product Part Color Description White
Product Total Weight Numeric Denominator
Generated Narrative: Ingredient fc09842a-8f71-48f2-9f9f-ff2441b2eb6f Profile: Drug Product Component status: Draft role: Active Ingredient substance Codes - Reference * Bundle: identifier = UUID:8a5a9684-f8fb-4f21-a397-a1a0996b2b7f; type = document; timestamp = 2023-12-09 07:12:23+0000 strength Strength Type: Mass concentration: 200 milligram (Details: UCUM codemg = 'mg')/1 arbitrary unit (Details: UCUM code[arb'U] = '[arb'U]') textConcentration: 200mg strength concentration: 16.65 percent (Details: UCUM code% = '%')
Generated Narrative: Ingredient 7f10a35e-228d-42db-8918-6ccada78454d Profile: Drug Product Component status: Draft role: Active Ingredient substance Codes - Reference * Bundle: identifier = UUID:8a5a9684-f8fb-4f21-a397-a1a0996b2b7f; type = document; timestamp = 2023-12-09 07:12:23+0000 strength Strength Type: Mass concentration: 300 milligram (Details: UCUM codemg = 'mg')/1 arbitrary unit (Details: UCUM code[arb'U] = '[arb'U]') textConcentration: 300mg strength concentration: 24.98 percent (Details: UCUM code% = '%')
Generated Narrative: Ingredient d01421cc-6488-468b-a676-d3e7281875e2 Profile: Drug Product Component status: Draft role: Inactive Ingredient substance Codes - Reference * Bundle: identifier = UUID:8a5a9684-f8fb-4f21-a397-a1a0996b2b7f; type = document; timestamp = 2023-12-09 07:12:23+0000 strength Strength Type: Mass concentration: 700 milligram (Details: UCUM codemg = 'mg')/1 arbitrary unit (Details: UCUM code[arb'U] = '[arb'U]') textConcentration: 700mg strength concentration: 58.28 percent (Details: UCUM code% = '%')
Generated Narrative: Ingredient 3791c4ce-2b43-4d7b-b195-0e5f88f28dab Profile: Drug Product Component status: Draft role: Inactive Ingredient substance Codes - Reference * Bundle: identifier = UUID:8a5a9684-f8fb-4f21-a397-a1a0996b2b7f; type = document; timestamp = 2023-12-09 07:12:23+0000 strength Strength Type: Mass concentration: 1 milligram (Details: UCUM codemg = 'mg')/1 arbitrary unit (Details: UCUM code[arb'U] = '[arb'U]') textConcentration: 1mg strength concentration: 0.08 percent (Details: UCUM code% = '%')
Generated Narrative: SubstanceDefinition 2d70d504-8cc6-4282-81d4-b20b0a98b78b Profile: Component Substance identifier: aspirin classification: Chemical grade: USP-NF manufacturer: Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000 supplier: Bundle: identifier = UUID:32532fe8-1bfb-4a0a-998d-9294742a9519; type = document; timestamp = 2024-06-19 21:06:21+0000 Codes - Code * R16CO5Y76E Names - Name Type Preferred * ASPIRIN GSRS Preferred Term true SourceMaterials - Type * Chemical
Generated Narrative: SubstanceDefinition fc878c4f-a98c-427c-816b-e03ccdf0e712 Profile: Component Substance identifier: acetaminophen classification: Chemical grade: USP-NF manufacturer: Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000 supplier: Bundle: identifier = UUID:32532fe8-1bfb-4a0a-998d-9294742a9519; type = document; timestamp = 2024-06-19 21:06:21+0000 Codes - Code * 362O9ITL9D Names - Name Type Preferred * ACETAMINOPHEN GSRS Preferred Term true SourceMaterials - Type * Chemical
Generated Narrative: SubstanceDefinition 393a14e7-3edc-4373-bbe5-9e569d504a1c Profile: Component Substance identifier: Maize starch classification: Mixture grade: Company Standard manufacturer: Bundle: identifier = UUID:7ce2088d-d281-4e2f-9a25-120a1f9805d1; type = document; timestamp = 2023-12-05 01:34:39+0000 supplier: Bundle: identifier = UUID:32532fe8-1bfb-4a0a-998d-9294742a9519; type = document; timestamp = 2024-06-19 21:06:21+0000 Codes - Code * O8232NY3SJ Names - Name Type Preferred * STARCH, CORN GSRS Preferred Term true SourceMaterials - Type Genus Species Part CountryOfOrigin * Plant zea mays kernel Argentina
Generated Narrative: SubstanceDefinition 496f83ad-2365-4b12-8672-a349d99f7d67 Profile: Component Substance identifier: Grape skin extract classification: Mixture grade: BP manufacturer: Bundle: identifier = UUID:7ce2088d-d281-4e2f-9a25-120a1f9805d1; type = document; timestamp = 2023-12-05 01:34:39+0000 supplier: Bundle: identifier = UUID:32532fe8-1bfb-4a0a-998d-9294742a9519; type = document; timestamp = 2024-06-19 21:06:21+0000 Codes - Code * 3GOV20705G Names - Name Type Preferred * WINE GRAPE GSRS Preferred Term true SourceMaterials - Type Genus Species Part CountryOfOrigin * Plant Vitis vinifera skin United States of America
Generated Narrative: Organization 4f3e9af1-306b-4fad-bf04-7881400b266a Profile: Basic Organization identifier: DUNS/143265222 name: Wunderwerke Contacts - Address * Wunderwerke, 123 Scenic Road, CT, Bridgeport, USA 65478
Wunderwerke, 123 Scenic Road, CT, Bridgeport, USA 65478
Generated Narrative: Organization 8ee60ed1-e22f-4d3b-ab08-8986e4e8e1d9 Profile: Basic Organization identifier: DUNS/123456789, DUNS/1234567 name: Sams BioPharm Contacts - Address * 2752 Main Street Princeton NJ 12345 USA
Generated Narrative: Organization 4b565cf3-5353-48af-8cd6-5ccf4e9fd579 Profile: Basic Organization identifier: DUNS/783452221, FEI/6913973 name: Manufacturing Site (J. Jones Research) Contacts - Address * Manufacturing Site (J. Jones Research), 444 Grant Street, Bedford, NY, United States
Manufacturing Site (J. Jones Research), 444 Grant Street, Bedford, NY, United States
Generated Narrative: Organization d9e7c2f7-0f59-4645-bb6d-5a8dd2425049 Profile: Basic Organization identifier: DUNS/173265332 name: Mega Chem Supply Contacts - Address * Mega Chem Supply, 350 W Main Street, Rochester, NY, United States
Mega Chem Supply, 350 W Main Street, Rochester, NY, United States
Generated Narrative: DocumentReference 928a3bb5-7be3-4d6e-830f-1a2fc6dcee9b Profile: Graphic Reference status: Current content Attachments - ContentType Data Title * image/png (base64 data - 499,360 base64 chars) bottlePlusCap.png