FDA.reportPublic FDA data

Application 040307

Type
ANDA
Sponsor
BARR

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATETABLET;ORAL500MG;2.5MGNoNo
002HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATETABLET;ORAL500MG;7.5MGNoNo
003HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATETABLET;ORAL650MG;7.5MGNoNo
004HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATETABLET;ORAL650MG;10MGNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040307-001HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE500MG;2.5MGTABLET / ORAL2000-07-26
A040307-002HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE500MG;7.5MGTABLET / ORAL2000-07-26
A040307-003HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE650MG;7.5MGTABLET / ORAL2000-07-26
A040307-004HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE650MG;10MGTABLET / ORAL2000-07-26

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 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A040307-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;2.5MGTABLET / ORAL2000-07-2684e616aacf4f…
2026-09-14 22:38:342026-08A040307-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;7.5MGTABLET / ORAL2000-07-2684e616aacf4f…
2026-09-14 22:38:342026-08A040307-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN650MG;7.5MGTABLET / ORAL2000-07-2684e616aacf4f…
2026-09-14 22:38:342026-08A040307-004HYDROCODONE BITARTRATE AND ACETAMINOPHEN650MG;10MGTABLET / ORAL2000-07-2684e616aacf4f…
2026-08-18 06:07:402026-07A040307-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;2.5MGTABLET / ORAL2000-07-26caaa826d4ba7…
2026-08-18 06:07:402026-07A040307-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;7.5MGTABLET / ORAL2000-07-26caaa826d4ba7…
2026-08-18 06:07:402026-07A040307-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN650MG;7.5MGTABLET / ORAL2000-07-26caaa826d4ba7…
2026-08-18 06:07:402026-07A040307-004HYDROCODONE BITARTRATE AND ACETAMINOPHEN650MG;10MGTABLET / ORAL2000-07-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040307-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;2.5MGTABLET / ORAL2000-07-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040307-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;7.5MGTABLET / ORAL2000-07-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040307-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN650MG;7.5MGTABLET / ORAL2000-07-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040307-004HYDROCODONE BITARTRATE AND ACETAMINOPHEN650MG;10MGTABLET / ORAL2000-07-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040307-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;2.5MGTABLET / ORAL2000-07-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040307-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;7.5MGTABLET / ORAL2000-07-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040307-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN650MG;7.5MGTABLET / ORAL2000-07-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040307-004HYDROCODONE BITARTRATE AND ACETAMINOPHEN650MG;10MGTABLET / ORAL2000-07-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A040307-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;2.5MGTABLET / ORAL2000-07-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040307-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;7.5MGTABLET / ORAL2000-07-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040307-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN650MG;7.5MGTABLET / ORAL2000-07-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040307-004HYDROCODONE BITARTRATE AND ACETAMINOPHEN650MG;10MGTABLET / ORAL2000-07-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040307-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;2.5MGTABLET / ORAL2000-07-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040307-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;7.5MGTABLET / ORAL2000-07-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040307-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN650MG;7.5MGTABLET / ORAL2000-07-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040307-004HYDROCODONE BITARTRATE AND ACETAMINOPHEN650MG;10MGTABLET / ORAL2000-07-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040307-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;2.5MGTABLET / ORAL2000-07-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040307-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;7.5MGTABLET / ORAL2000-07-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040307-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN650MG;7.5MGTABLET / ORAL2000-07-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040307-004HYDROCODONE BITARTRATE AND ACETAMINOPHEN650MG;10MGTABLET / ORAL2000-07-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040307-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;2.5MGTABLET / ORAL2000-07-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040307-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;7.5MGTABLET / ORAL2000-07-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040307-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN650MG;7.5MGTABLET / ORAL2000-07-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040307-004HYDROCODONE BITARTRATE AND ACETAMINOPHEN650MG;10MGTABLET / ORAL2000-07-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040307-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;2.5MGTABLET / ORAL2000-07-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040307-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;7.5MGTABLET / ORAL2000-07-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040307-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN650MG;7.5MGTABLET / ORAL2000-07-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040307-004HYDROCODONE BITARTRATE AND ACETAMINOPHEN650MG;10MGTABLET / ORAL2000-07-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040307-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;2.5MGTABLET / ORAL2000-07-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040307-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;7.5MGTABLET / ORAL2000-07-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040307-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN650MG;7.5MGTABLET / ORAL2000-07-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040307-004HYDROCODONE BITARTRATE AND ACETAMINOPHEN650MG;10MGTABLET / ORAL2000-07-265bbf6a4d5a75…

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 8 of 8 · 146 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENProficient Rx LPc6210466-5feb-45d9-b637-b3f482bc3c2b2022-05-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Acetaminophen
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENProficient Rx LP199d4915-cb3b-48f3-835d-a45d04a5c9402022-04-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Acetaminophen
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENProficient Rx LP50be5d00-758e-4d01-8e78-40a60dbe67e52021-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Acetaminophen
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENProficient Rx LPbab189ed-ff83-453c-a243-7ff052b2e4912021-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Acetaminophen
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENXLCare Pharmaceuticals, Inc.73dea6de-20cb-4cef-b987-3ab2c64e5edb2019-11-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Acetaminophen
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENSun Pharmaceutical Industries, Inc.6e153073-ca78-481e-9e9c-0365ee3f3d592018-07-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Acetaminophen

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
42613ORIG2000-07-26
7617ORIG2000-07-26