FDA.reportPublic FDA data

Application 201013

Type
ANDA
Sponsor
AUROLIFE PHARMA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATETABLET;ORAL325MG;5MGNoNo
002HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATETABLET;ORAL325MG;7.5MGNoNo
003HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATETABLET;ORAL325MG;10MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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.

Product history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A201013-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2012-04-1184e616aacf4f…
2026-09-14 22:38:342026-08A201013-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2012-04-1184e616aacf4f…
2026-09-14 22:38:342026-08A201013-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2012-04-1184e616aacf4f…
2026-08-18 06:07:402026-07A201013-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2012-04-11caaa826d4ba7…
2026-08-18 06:07:402026-07A201013-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2012-04-11caaa826d4ba7…
2026-08-18 06:07:402026-07A201013-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2012-04-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A201013-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2012-04-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201013-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2012-04-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201013-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2012-04-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201013-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2012-04-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201013-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2012-04-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201013-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2012-04-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A201013-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2012-04-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201013-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2012-04-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201013-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2012-04-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201013-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2012-04-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201013-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2012-04-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201013-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2012-04-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201013-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2012-04-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201013-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2012-04-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201013-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2012-04-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201013-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2012-04-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201013-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2012-04-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201013-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2012-04-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201013-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2012-04-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201013-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2012-04-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201013-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2012-04-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201013-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2012-04-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201013-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2012-04-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201013-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2012-04-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201013-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2012-04-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201013-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2012-04-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201013-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2012-04-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201013-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2012-04-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A201013-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2012-04-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A201013-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2012-04-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201013-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2012-04-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201013-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2012-04-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201013-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2012-04-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201013-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2012-04-11301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A201013-001AA184e616aacf4f…
2026-09-14 22:38:342026-08A201013-002AA184e616aacf4f…
2026-09-14 22:38:342026-08A201013-003AA184e616aacf4f…
2026-08-18 06:07:402026-07A201013-001AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A201013-002AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A201013-003AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A201013-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201013-002AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201013-003AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201013-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201013-002AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201013-003AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A201013-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201013-002AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201013-003AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201013-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201013-002AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201013-003AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201013-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201013-002AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201013-003AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201013-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201013-002AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201013-003AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201013-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201013-002AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201013-003AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201013-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201013-002AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201013-003AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201013-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201013-002AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201013-003AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201013-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A201013-002AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A201013-003AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201013-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201013-002AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201013-003AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201013-001AA1301d65b070ca…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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
ndc (product): 71335-1271
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
ndc (product): 71335-1339
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
ndc (product): 71335-0108
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
ndc (product): 68071-4941
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
ndc (product): 68071-4801
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
ndc (product): 68071-4853
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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 101 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
67296-1791Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenRedPharm Drug, Inc.ANDACurrent
68071-4801Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4801Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4801Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4853Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4853Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4941Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4941Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5201Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5201Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenNuCare Pharmaceuticals,Inc.ANDACurrent
70934-555Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-555Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71335-0108Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
71335-0108Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
71335-0960Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
71335-0960Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
71335-1271Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
71335-1271Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
71335-1271Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
71335-1339Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
71335-1339Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76323ORIG 2023-11-03