FDA.reportPublic FDA data

Hydrocodone Bitartrate and Acetaminophen

Product NDC
35356-797
11-digit product format
353560797
Labeler code
35356
Product ID
35356-797_007b5379-4c11-417b-ab14-77b39a6435ad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Lake Erie Medical DBA Quality Care Products LLC
Application
ANDA201013
Marketing category
ANDA
Marketing start
2012-04-12
Marketing end
0000-00-00
Substance
HYDROCODONE BITARTRATE; ACETAMINOPHEN
Active strength
8 mg/1; mg/1
Pharmacologic classes
Opioid Agonist [EPC],Opioid Agonists [MoA]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 10 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct35356-797DDiscontinued by firm2026-07-31
excluded packagepackage35356-79735356-797-01DDiscontinued by firm2026-07-31
excluded packagepackage35356-79735356-797-08DDiscontinued by firm2026-07-31
excluded packagepackage35356-79735356-797-15DDiscontinued by firm2026-07-31
excluded packagepackage35356-79735356-797-20DDiscontinued by firm2026-07-31
excluded packagepackage35356-79735356-797-30DDiscontinued by firm2026-07-31
excluded packagepackage35356-79735356-797-40DDiscontinued by firm2026-07-31
excluded packagepackage35356-79735356-797-50DDiscontinued by firm2026-07-31
excluded packagepackage35356-79735356-797-60DDiscontinued by firm2026-07-31
excluded packagepackage35356-79735356-797-90DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A201013-001HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE325MG;5MGTABLET / ORALAA2012-04-11
A201013-002HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE325MG;7.5MGTABLET / ORALAA2012-04-11
A201013-003HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE325MG;10MGTABLET / ORALAA2012-04-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A201013-001AA
A201013-002AA
A201013-003AA

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A201013-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2012-04-11a50c72e98297…
2026-08-01 22:54:322026-06A201013-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2012-04-11a50c72e98297…
2026-08-01 22:54:322026-06A201013-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2012-04-11a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A201013-001AA1a50c72e98297…
2026-08-01 22:54:322026-06A201013-002AA1a50c72e98297…
2026-08-01 22:54:322026-06A201013-003AA1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepackddfe71cc-27bf-4807-b62f-e6cf982e2dfd2026-06-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201013
application number: ANDA201013
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack88c031ee-3d3d-4e8a-b69b-d18db612a9f32026-01-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201013
application number: ANDA201013
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENAurolife Pharma, LLC60f43308-1deb-4f05-8f17-aa49ebdcf4982025-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201013
application number: ANDA201013
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack59a92d79-5b2d-4c10-b0ac-ea766a0ff08b2024-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201013
application number: ANDA201013
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENNuCare Pharmaceuticals,Inc.8b132cf3-c138-59ae-e053-2995a90a98a22024-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201013
application number: ANDA201013
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENNuCare Pharmaceuticals,Inc.8c2a7a68-5a84-c909-e053-2995a90ad5b62024-06-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201013
application number: ANDA201013
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENNuCare Pharmaceuticals,Inc.8592e901-9353-6fb6-e053-2a91aa0ad33b2024-06-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201013
application number: ANDA201013
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENNuCare Pharmaceuticals,Inc.86be8920-2f35-fbc3-e053-2991aa0a00152024-06-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201013
application number: ANDA201013
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENProficient Rx LP82b24978-8b15-43a9-b5b0-3313ed2a73c22023-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201013
application number: ANDA201013
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENProficient Rx LPe6711f26-a01d-43e8-882a-d58561e4b67f2022-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201013
application number: ANDA201013
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENProficient Rx LP199d4915-cb3b-48f3-835d-a45d04a5c9402022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201013
application number: ANDA201013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
35356-797-01EA - Each35356-797b84ec87a-59d3-4f3e-af0f-bd604c6541a012013-02-13
35356-797-08EA - Each35356-797a685a4dd-a012-419c-a3a4-f7e4521bb47b12014-01-04
35356-797-15EA - Each35356-797db4cad32-46d1-4657-b043-e477ea9b2ea312015-10-02
35356-797-30EA - Each35356-797b5bb4566-f06c-4843-8a52-d9a43c5b06f612013-02-13
35356-797-40EA - Each35356-7972732d2fe-ad50-4a0d-a6c0-a7f4ff96320d12013-02-13
35356-797-60EA - Each35356-7978f8c9e8e-9350-48a0-8bee-7ee50ad43be512013-02-13
35356-797-90EA - Each35356-7979457c145-ed4e-4361-8f24-3b17f076207e12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]6
HYDROCODONE BITARTRATEACTIVE INGREDIENTNO70W886KKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]6
ACETAMINOPHENACTIVE MOIETY362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]6
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]6
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]6
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]6
POVIDONE K30INACTIVE INGREDIENTU725QWY32XHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]6
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]6