Home NDC 53746-116-01 Hydrocodone Bitartrate and Ibuprofen
Product NDC 53746-116
Requested package NDC 53746-116-01
11-digit product format 537460116
Labeler code 53746
Product ID 53746-116_e109d65b-643b-4c2e-80ad-30c7b3e9c160
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydrocodone Bitartrate and Ibuprofen
Dosage form TABLET
Route ORAL
Labeler Amneal Pharmaceuticals of New York LLC
Application ANDA076642
Marketing category ANDA
Marketing start 2010-02-18
Substance HYDROCODONE BITARTRATE; IBUPROFEN
Active strength 2.5; 200 mg/1; mg/1
Pharmacologic classes Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], Opioid Agonist [EPC], Opioid Agonists [MoA]
DEA schedule CII
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076642-001 HYDROCODONE BITARTRATE AND IBUPROFEN HYDROCODONE BITARTRATE; IBUPROFEN 7.5MG;200MG TABLET / ORAL AB RS 2004-10-12 A076642-002 HYDROCODONE BITARTRATE AND IBUPROFEN HYDROCODONE BITARTRATE; IBUPROFEN 5MG;200MG TABLET / ORAL 2004-03-18 A076642-003 REPREXAIN HYDROCODONE BITARTRATE; IBUPROFEN 2.5MG;200MG TABLET / ORAL 2007-10-19 A076642-004 REPREXAIN HYDROCODONE BITARTRATE; IBUPROFEN 10MG;200MG TABLET / ORAL 2007-10-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076642-001 AB
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A076642-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB RS 2004-10-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076642-002 HYDROCODONE BITARTRATE AND IBUPROFEN 5MG;200MG TABLET / ORAL 2004-03-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076642-003 REPREXAIN 2.5MG;200MG TABLET / ORAL 2007-10-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076642-004 REPREXAIN 10MG;200MG TABLET / ORAL 2007-10-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076642-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB RS 2004-10-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076642-002 HYDROCODONE BITARTRATE AND IBUPROFEN 5MG;200MG TABLET / ORAL 2004-03-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076642-003 REPREXAIN 2.5MG;200MG TABLET / ORAL 2007-10-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076642-004 REPREXAIN 10MG;200MG TABLET / ORAL 2007-10-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076642-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB RS 2004-10-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076642-002 HYDROCODONE BITARTRATE AND IBUPROFEN 5MG;200MG TABLET / ORAL 2004-03-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076642-003 REPREXAIN 2.5MG;200MG TABLET / ORAL 2007-10-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076642-004 REPREXAIN 10MG;200MG TABLET / ORAL 2007-10-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076642-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB RS 2004-10-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076642-002 HYDROCODONE BITARTRATE AND IBUPROFEN 5MG;200MG TABLET / ORAL 2004-03-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076642-003 REPREXAIN 2.5MG;200MG TABLET / ORAL 2007-10-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076642-004 REPREXAIN 10MG;200MG TABLET / ORAL 2007-10-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076642-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB RS 2004-10-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076642-002 HYDROCODONE BITARTRATE AND IBUPROFEN 5MG;200MG TABLET / ORAL 2004-03-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076642-003 REPREXAIN 2.5MG;200MG TABLET / ORAL 2007-10-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076642-004 REPREXAIN 10MG;200MG TABLET / ORAL 2007-10-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076642-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB RS 2004-10-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076642-002 HYDROCODONE BITARTRATE AND IBUPROFEN 5MG;200MG TABLET / ORAL 2004-03-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076642-003 REPREXAIN 2.5MG;200MG TABLET / ORAL 2007-10-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076642-004 REPREXAIN 10MG;200MG TABLET / ORAL 2007-10-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076642-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB RS 2004-10-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076642-002 HYDROCODONE BITARTRATE AND IBUPROFEN 5MG;200MG TABLET / ORAL 2004-03-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076642-003 REPREXAIN 2.5MG;200MG TABLET / ORAL 2007-10-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076642-004 REPREXAIN 10MG;200MG TABLET / ORAL 2007-10-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076642-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB RS 2004-10-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076642-002 HYDROCODONE BITARTRATE AND IBUPROFEN 5MG;200MG TABLET / ORAL 2004-03-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076642-003 REPREXAIN 2.5MG;200MG TABLET / ORAL 2007-10-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076642-004 REPREXAIN 10MG;200MG TABLET / ORAL 2007-10-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076642-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB RS 2004-10-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076642-002 HYDROCODONE BITARTRATE AND IBUPROFEN 5MG;200MG TABLET / ORAL AB 2004-03-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076642-003 REPREXAIN 2.5MG;200MG TABLET / ORAL 2007-10-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076642-004 REPREXAIN 10MG;200MG TABLET / ORAL 2007-10-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076642-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB RS 2004-10-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076642-002 HYDROCODONE BITARTRATE AND IBUPROFEN 5MG;200MG TABLET / ORAL AB 2004-03-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076642-003 REPREXAIN 2.5MG;200MG TABLET / ORAL 2007-10-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076642-004 REPREXAIN 10MG;200MG TABLET / ORAL 2007-10-19 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Hydrocodone Bitartrate and Ibuprofen
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROCODONE BITARTRATE 2.5 mg/1 IBUPROFEN 200 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination WK2XYI10QM Internal UNII lookup NO70W886KK Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 858770 Internal RxNorm lookup 858778 Internal RxNorm lookup 858798 Internal RxNorm lookup 859315 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53746-116-01 Hydrocodone Bitartrate and Ibuprofen 100 in 1 BOTTLE TABLET 100 46
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded HYDROCODONE BITARTRATE ACTIVE INGREDIENT NO70W886KK HYDROCODONE BITARTRATE AND IBUPROFEN TABLET [BRYANT RANCH PREPACK] 1000 IBUPROFEN ACTIVE INGREDIENT WK2XYI10QM HYDROCODONE BITARTRATE AND IBUPROFEN TABLET [BRYANT RANCH PREPACK] 1000 HYDROCODONE ACTIVE MOIETY 6YKS4Y3WQ7 HYDROCODONE BITARTRATE AND IBUPROFEN TABLET [BRYANT RANCH PREPACK] 1000 IBUPROFEN ACTIVE MOIETY WK2XYI10QM HYDROCODONE BITARTRATE AND IBUPROFEN TABLET [BRYANT RANCH PREPACK] 1000 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ HYDROCODONE BITARTRATE AND IBUPROFEN TABLET [BRYANT RANCH PREPACK] 1000 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U HYDROCODONE BITARTRATE AND IBUPROFEN TABLET [BRYANT RANCH PREPACK] 1000 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 HYDROCODONE BITARTRATE AND IBUPROFEN TABLET [BRYANT RANCH PREPACK] 1000 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO HYDROCODONE BITARTRATE AND IBUPROFEN TABLET [BRYANT RANCH PREPACK] 1000 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 HYDROCODONE BITARTRATE AND IBUPROFEN TABLET [BRYANT RANCH PREPACK] 1000 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE HYDROCODONE BITARTRATE AND IBUPROFEN TABLET [BRYANT RANCH PREPACK] 1000 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A HYDROCODONE BITARTRATE AND IBUPROFEN TABLET [BRYANT RANCH PREPACK] 1000 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 HYDROCODONE BITARTRATE AND IBUPROFEN TABLET [BRYANT RANCH PREPACK] 1000 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ HYDROCODONE BITARTRATE AND IBUPROFEN TABLET [BRYANT RANCH PREPACK] 1000 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP HYDROCODONE BITARTRATE AND IBUPROFEN TABLET [BRYANT RANCH PREPACK] 1000 HYDROCODONE BITARTRATE ACTIVE INGREDIENT NO70W886KK HYDROCODONE BITARTRATE AND IBUPROFEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 16 IBUPROFEN ACTIVE INGREDIENT WK2XYI10QM HYDROCODONE BITARTRATE AND IBUPROFEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 16 HYDROCODONE ACTIVE MOIETY 6YKS4Y3WQ7 HYDROCODONE BITARTRATE AND IBUPROFEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 16 IBUPROFEN ACTIVE MOIETY WK2XYI10QM HYDROCODONE BITARTRATE AND IBUPROFEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 16 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ HYDROCODONE BITARTRATE AND IBUPROFEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 16 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U HYDROCODONE BITARTRATE AND IBUPROFEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 16 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 HYDROCODONE BITARTRATE AND IBUPROFEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 16 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G HYDROCODONE BITARTRATE AND IBUPROFEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 16 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO HYDROCODONE BITARTRATE AND IBUPROFEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 16 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 HYDROCODONE BITARTRATE AND IBUPROFEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 16 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE HYDROCODONE BITARTRATE AND IBUPROFEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 16 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A HYDROCODONE BITARTRATE AND IBUPROFEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 16 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 HYDROCODONE BITARTRATE AND IBUPROFEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 16 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ HYDROCODONE BITARTRATE AND IBUPROFEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 16 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP HYDROCODONE BITARTRATE AND IBUPROFEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 16 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 HYDROCODONE BITARTRATE AND IBUPROFEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 16
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53746-116 HYDROCODONE BITARTRATE AND IBUPROFEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] 42 Current NDC, Legacy NDC, 1 package rows 20241030_abc33718-4e88-43ea-9ffa-2b04ffc812ef.zip
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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 53746-116-01 53746011601 100 TABLET in 1 BOTTLE (53746-116-01) 100 tablet 2010-02-18 0000-00-00 No No Current