Home NDC 62037-524 HYDROCODONE BITARTRATE AND IBUPROFEN
Product NDC 62037-524
11-digit product format 620370524
Labeler code 62037
Product ID 62037-524_e5666a18-5187-4405-b7c5-a45736cdedde
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name HYDROCODONE BITARTRATE AND IBUPROFEN
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Actavis Pharma, Inc.
Application ANDA076604
Marketing category ANDA
Marketing start 2004-04-01
Marketing end 2019-09-30
Substance HYDROCODONE BITARTRATE; IBUPROFEN
Active strength 8 mg/1; mg/1
Pharmacologic classes Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
DEA schedule CII
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076604-001 HYDROCODONE BITARTRATE AND IBUPROFEN HYDROCODONE BITARTRATE; IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2003-12-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076604-001 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 2 · 43 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 A076604-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2003-12-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076604-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2003-12-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076604-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2003-12-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076604-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2003-12-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076604-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2003-12-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076604-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2003-12-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076604-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2003-12-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076604-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2003-12-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076604-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2003-12-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076604-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2003-12-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076604-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2003-12-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076604-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2003-12-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076604-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2003-12-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076604-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2003-12-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076604-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2003-12-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076604-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2003-12-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076604-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2003-12-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076604-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2003-12-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076604-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2003-12-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076604-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2003-12-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076604-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2003-12-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076604-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2003-12-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076604-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2003-12-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076604-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2003-12-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076604-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2003-12-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076604-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2003-12-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076604-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2003-12-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076604-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2003-12-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076604-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2003-12-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076604-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2003-12-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076604-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2003-12-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076604-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2003-12-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076604-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2003-12-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076604-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2003-12-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076604-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2003-12-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076604-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2003-12-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076604-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2003-12-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076604-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2003-12-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076604-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2003-12-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076604-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2003-12-31 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# 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, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 2 IBUPROFEN ACTIVE INGREDIENT WK2XYI10QM HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 2 HYDROCODONE ACTIVE MOIETY 6YKS4Y3WQ7 HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 2 IBUPROFEN ACTIVE MOIETY WK2XYI10QM HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 2 HYPROMELLOSE 2910 (3 MPA.S) INACTIVE INGREDIENT 0VUT3PMY82 HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 2 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 2 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 2 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 2 POLYETHYLENE GLYCOL 8000 INACTIVE INGREDIENT Q662QK8M3B HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 2 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 2 HYDROCODONE BITARTRATE ACTIVE INGREDIENT NO70W886KK HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 IBUPROFEN ACTIVE INGREDIENT WK2XYI10QM HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 HYDROCODONE ACTIVE MOIETY 6YKS4Y3WQ7 HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 IBUPROFEN ACTIVE MOIETY WK2XYI10QM HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 HYPROMELLOSE 2910 (3 MPA.S) INACTIVE INGREDIENT 0VUT3PMY82 HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 POLYETHYLENE GLYCOL 8000 INACTIVE INGREDIENT Q662QK8M3B HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 STARCH, PREGELATINIZED CORN INACTIVE INGREDIENT O8232NY3SJ HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1
DailyMed RxNorm Mappings#