Home NDC 0603-3584-21 Hydrocodone Bitartrate and Ibuprofen
Product NDC 0603-3584
Requested package NDC 0603-3584-21
11-digit product format 006033584
Labeler code 0603
Product ID 0603-3584_5a16489b-5f9c-4961-8b6f-4fa15ebf7396
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name hydrocodone bitartrate and ibuprofen
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Par Pharmaceutical
Application ANDA077727
Marketing category ANDA
Marketing start 2006-11-06
Marketing end 0000-00-00
Substance HYDROCODONE BITARTRATE; IBUPROFEN
Active strength 5 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 2020-12-31
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog .
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.
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 2019-12-13 00:20 UTC 2019-12 A077727-001 HYDROCODONE BITARTRATE AND IBUPROFEN 5MG;200MG TABLET / ORAL AB 2006-11-06 74a2ff9319b5…2021-12-28 21:50 UTC 2021-12 A077727-001 HYDROCODONE BITARTRATE AND IBUPROFEN 5MG;200MG TABLET / ORAL AB 2006-11-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A077727-001 HYDROCODONE BITARTRATE AND IBUPROFEN 5MG;200MG TABLET / ORAL AB 2006-11-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A077727-001 HYDROCODONE BITARTRATE AND IBUPROFEN 5MG;200MG TABLET / ORAL AB 2006-11-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A077727-001 HYDROCODONE BITARTRATE AND IBUPROFEN 5MG;200MG TABLET / ORAL AB 2006-11-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A077727-001 HYDROCODONE BITARTRATE AND IBUPROFEN 5MG;200MG TABLET / ORAL AB 2006-11-06 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A077727-001 HYDROCODONE BITARTRATE AND IBUPROFEN 5MG;200MG TABLET / ORAL AB 2006-11-06 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A077727-001 HYDROCODONE BITARTRATE AND IBUPROFEN 5MG;200MG TABLET / ORAL AB 2006-11-06 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077727-001 HYDROCODONE BITARTRATE AND IBUPROFEN 5MG;200MG TABLET / ORAL AB 2006-11-06 ea99ee380514…
Observed Orange Book normalized TE history# 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 0603-3584-21 00603358421 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0603-3584-21) 2006-11-06 0000-00-00 No No Current