Home NDC 0603-3586 Hydrocodone Bitartrate and Ibuprofen
Product NDC 0603-3586
11-digit product format 006033586
Labeler code 0603
Product ID 0603-3586_0bf35876-d107-487d-9908-588c8c50e3b6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name hydrocodone bitartrate and ibuprofen
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Par Pharmaceutical, Inc.
Application ANDA077723
Marketing category ANDA
Marketing start 2006-11-06
Marketing end 2022-05-31
Substance HYDROCODONE BITARTRATE; IBUPROFEN
Active strength 10 mg/1; mg/1
Pharmacologic classes Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],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# Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.
Historic NDC status page 1 of 1 · 12 matching rows.
Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 0603-3586 D Discontinued by firm excluded / ndc_excluded.zip 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0603-3586 0603-3586-21 D Discontinued by firm excluded / ndc_excluded.zip 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product 0603-3586 D Discontinued by firm excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0603-3586 0603-3586-21 D Discontinued by firm excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0603-3586 D Discontinued by firm excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0603-3586 0603-3586-21 D Discontinued by firm excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product 0603-3586 D Discontinued by firm excluded / ndc_excluded.zip ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0603-3586 0603-3586-21 D Discontinued by firm excluded / ndc_excluded.zip ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 0603-3586 D Discontinued by firm excluded / ndc_excluded.zip 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0603-3586 0603-3586-21 D Discontinued by firm excluded / ndc_excluded.zip 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 0603-3586 D Discontinued by firm excluded / ndc_excluded.zip 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0603-3586 0603-3586-21 D Discontinued by firm excluded / ndc_excluded.zip 557ba5c1ecfa…9c80585c8c6e…
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077723-001 HYDROCODONE BITARTRATE AND IBUPROFEN HYDROCODONE BITARTRATE; IBUPROFEN 7.5MG;200MG TABLET / ORAL 2006-11-06 A077723-002 HYDROCODONE BITARTRATE AND IBUPROFEN HYDROCODONE BITARTRATE; IBUPROFEN 10MG;200MG TABLET / ORAL 2006-11-06 A077723-003 HYDROCODONE HYDROCODONE BITARTRATE; IBUPROFEN 5MG;200MG TABLET / ORAL 2006-11-06
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 3 · 114 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 2026-02-19 14:30 UTC 2026-02 A077723-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL 2006-11-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077723-002 HYDROCODONE BITARTRATE AND IBUPROFEN 10MG;200MG TABLET / ORAL 2006-11-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077723-003 HYDROCODONE 5MG;200MG TABLET / ORAL 2006-11-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077723-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL 2006-11-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077723-002 HYDROCODONE BITARTRATE AND IBUPROFEN 10MG;200MG TABLET / ORAL 2006-11-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077723-003 HYDROCODONE 5MG;200MG TABLET / ORAL 2006-11-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077723-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL 2006-11-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077723-002 HYDROCODONE BITARTRATE AND IBUPROFEN 10MG;200MG TABLET / ORAL 2006-11-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077723-003 HYDROCODONE 5MG;200MG TABLET / ORAL 2006-11-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077723-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL 2006-11-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077723-002 HYDROCODONE BITARTRATE AND IBUPROFEN 10MG;200MG TABLET / ORAL 2006-11-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077723-003 HYDROCODONE 5MG;200MG TABLET / ORAL 2006-11-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077723-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL 2006-11-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077723-002 HYDROCODONE BITARTRATE AND IBUPROFEN 10MG;200MG TABLET / ORAL 2006-11-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077723-003 HYDROCODONE 5MG;200MG TABLET / ORAL 2006-11-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077723-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL 2006-11-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077723-002 HYDROCODONE BITARTRATE AND IBUPROFEN 10MG;200MG TABLET / ORAL 2006-11-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077723-003 HYDROCODONE 5MG;200MG TABLET / ORAL 2006-11-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077723-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2006-11-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077723-002 HYDROCODONE BITARTRATE AND IBUPROFEN 10MG;200MG TABLET / ORAL 2006-11-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077723-003 HYDROCODONE 5MG;200MG TABLET / ORAL AB 2006-11-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077723-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2006-11-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077723-002 HYDROCODONE BITARTRATE AND IBUPROFEN 10MG;200MG TABLET / ORAL 2006-11-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077723-003 HYDROCODONE 5MG;200MG TABLET / ORAL AB 2006-11-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077723-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2006-11-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077723-002 HYDROCODONE BITARTRATE AND IBUPROFEN 10MG;200MG TABLET / ORAL 2006-11-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077723-003 HYDROCODONE 5MG;200MG TABLET / ORAL AB 2006-11-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077723-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2006-11-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077723-002 HYDROCODONE BITARTRATE AND IBUPROFEN 10MG;200MG TABLET / ORAL 2006-11-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077723-003 HYDROCODONE 5MG;200MG TABLET / ORAL AB 2006-11-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077723-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2006-11-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077723-002 HYDROCODONE BITARTRATE AND IBUPROFEN 10MG;200MG TABLET / ORAL 2006-11-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077723-003 HYDROCODONE 5MG;200MG TABLET / ORAL AB 2006-11-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077723-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2006-11-06 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077723-002 HYDROCODONE BITARTRATE AND IBUPROFEN 10MG;200MG TABLET / ORAL 2006-11-06 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077723-003 HYDROCODONE 5MG;200MG TABLET / ORAL AB 2006-11-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077723-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2006-11-06 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077723-002 HYDROCODONE BITARTRATE AND IBUPROFEN 10MG;200MG TABLET / ORAL 2006-11-06 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077723-003 HYDROCODONE 5MG;200MG TABLET / ORAL AB 2006-11-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077723-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2006-11-06 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 66 observed states.
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 [QUALITEST PHARMACEUTICALS] 5 IBUPROFEN ACTIVE INGREDIENT WK2XYI10QM HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [QUALITEST PHARMACEUTICALS] 5 HYDROCODONE ACTIVE MOIETY 6YKS4Y3WQ7 HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [QUALITEST PHARMACEUTICALS] 5 IBUPROFEN ACTIVE MOIETY WK2XYI10QM HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [QUALITEST PHARMACEUTICALS] 5 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [QUALITEST PHARMACEUTICALS] 5 D&C RED NO. 27 INACTIVE INGREDIENT 2LRS185U6K HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [QUALITEST PHARMACEUTICALS] 5 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [QUALITEST PHARMACEUTICALS] 5 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [QUALITEST PHARMACEUTICALS] 5 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [QUALITEST PHARMACEUTICALS] 5 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [QUALITEST PHARMACEUTICALS] 5 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [QUALITEST PHARMACEUTICALS] 5 POVIDONES INACTIVE INGREDIENT FZ989GH94E HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [QUALITEST PHARMACEUTICALS] 5 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [QUALITEST PHARMACEUTICALS] 5 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [QUALITEST PHARMACEUTICALS] 5 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [QUALITEST PHARMACEUTICALS] 5 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [QUALITEST PHARMACEUTICALS] 5
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0603-3586-21 00603358621 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0603-3586-21) 2006-11-06 2022-05-31 No No Current