Home NDC 63629-5437-6 Hydrocodone Bitartrate and Ibuprofen
Product NDC 63629-5437
Requested package NDC 63629-5437-6
11-digit product format 636295437
Labeler code 63629
Product ID 63629-5437_03512d03-fad7-4ab5-81fc-83ca86faef90
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydrocodone Bitartrate and Ibuprofen
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA076642
Marketing category ANDA
Marketing start 2010-02-18
Marketing end 0000-00-00
Substance HYDROCODONE BITARTRATE; IBUPROFEN
Active strength 3 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 2023-12-31
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 · 16 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2021-12-27 23:28 UTC · source 2021-12-27 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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.
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 63629-5437-0 2022-02-16 Hydrocodone Bitartrate and Ibuprofen Tablets CII (2.5 mg/200 mg , 5 mg/200 mg , 7.5 mg/200 mg & 10 mg/200 mg) Rx Only 63629-5437-1 2022-02-16 Hydrocodone Bitartrate and Ibuprofen Tablets CII (2.5 mg/200 mg , 5 mg/200 mg , 7.5 mg/200 mg & 10 mg/200 mg) Rx Only 63629-5437-2 2022-02-16 Hydrocodone Bitartrate and Ibuprofen Tablets CII (2.5 mg/200 mg , 5 mg/200 mg , 7.5 mg/200 mg & 10 mg/200 mg) Rx Only 63629-5437-3 2022-02-16 Hydrocodone Bitartrate and Ibuprofen Tablets CII (2.5 mg/200 mg , 5 mg/200 mg , 7.5 mg/200 mg & 10 mg/200 mg) Rx Only 63629-5437-4 2022-02-16 Hydrocodone Bitartrate and Ibuprofen Tablets CII (2.5 mg/200 mg , 5 mg/200 mg , 7.5 mg/200 mg & 10 mg/200 mg) Rx Only 63629-5437-5 2022-02-16 Hydrocodone Bitartrate and Ibuprofen Tablets CII (2.5 mg/200 mg , 5 mg/200 mg , 7.5 mg/200 mg & 10 mg/200 mg) Rx Only 63629-5437-6 2022-02-16 Hydrocodone Bitartrate and Ibuprofen Tablets CII (2.5 mg/200 mg , 5 mg/200 mg , 7.5 mg/200 mg & 10 mg/200 mg) Rx Only 63629-5437-7 2022-02-16 Hydrocodone Bitartrate and Ibuprofen Tablets CII (2.5 mg/200 mg , 5 mg/200 mg , 7.5 mg/200 mg & 10 mg/200 mg) Rx Only 63629-5437-8 2022-02-16 Hydrocodone Bitartrate and Ibuprofen Tablets CII (2.5 mg/200 mg , 5 mg/200 mg , 7.5 mg/200 mg & 10 mg/200 mg) Rx Only 63629-5437-9 2022-02-16 Hydrocodone Bitartrate and Ibuprofen Tablets CII (2.5 mg/200 mg , 5 mg/200 mg , 7.5 mg/200 mg & 10 mg/200 mg) Rx Only 63629-5437-0 2020-01-31 Hydrocodone Bitartrate and Ibuprofen Tablets CII (2.5 mg/200 mg , 5 mg/200 mg , 7.5 mg/200 mg & 10 mg/200 mg) Rx Only 63629-5437-1 2020-01-31 Hydrocodone Bitartrate and Ibuprofen Tablets CII (2.5 mg/200 mg , 5 mg/200 mg , 7.5 mg/200 mg & 10 mg/200 mg) Rx Only 63629-5437-2 2020-01-31 Hydrocodone Bitartrate and Ibuprofen Tablets CII (2.5 mg/200 mg , 5 mg/200 mg , 7.5 mg/200 mg & 10 mg/200 mg) Rx Only 63629-5437-3 2020-01-31 Hydrocodone Bitartrate and Ibuprofen Tablets CII (2.5 mg/200 mg , 5 mg/200 mg , 7.5 mg/200 mg & 10 mg/200 mg) Rx Only 63629-5437-4 2020-01-31 Hydrocodone Bitartrate and Ibuprofen Tablets CII (2.5 mg/200 mg , 5 mg/200 mg , 7.5 mg/200 mg & 10 mg/200 mg) Rx Only 63629-5437-5 2020-01-31 Hydrocodone Bitartrate and Ibuprofen Tablets CII (2.5 mg/200 mg , 5 mg/200 mg , 7.5 mg/200 mg & 10 mg/200 mg) Rx Only 63629-5437-6 2020-01-31 Hydrocodone Bitartrate and Ibuprofen Tablets CII (2.5 mg/200 mg , 5 mg/200 mg , 7.5 mg/200 mg & 10 mg/200 mg) Rx Only 63629-5437-7 2020-01-31 Hydrocodone Bitartrate and Ibuprofen Tablets CII (2.5 mg/200 mg , 5 mg/200 mg , 7.5 mg/200 mg & 10 mg/200 mg) Rx Only 63629-5437-8 2020-01-31 Hydrocodone Bitartrate and Ibuprofen Tablets CII (2.5 mg/200 mg , 5 mg/200 mg , 7.5 mg/200 mg & 10 mg/200 mg) Rx Only 63629-5437-9 2020-01-31 Hydrocodone Bitartrate and Ibuprofen Tablets CII (2.5 mg/200 mg , 5 mg/200 mg , 7.5 mg/200 mg & 10 mg/200 mg) Rx Only
DailyMed Socrata Ingredients# 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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63629-5437-6 63629543706 45 TABLET in 1 BOTTLE (63629-5437-6) 45 tablet 2022-02-08 0000-00-00 No No Current