Home NDC 67296-1655-7 Hydrocodone Bitartrate and Ibuprofen
Product NDC 67296-1655
Requested package NDC 67296-1655-7
11-digit product format 672961655
Labeler code 67296
Product ID 67296-1655_b8df8259-aecc-dee4-e053-2995a90aa87b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydrocodone Bitartrate and Ibuprofen
Dosage form TABLET, FILM COATED
Route ORAL
Labeler RedPharm Drug, Inc.
Application ANDA204575
Marketing category ANDA
Marketing start 2019-01-01
Marketing end 0000-00-00
Substance HYDROCODONE BITARTRATE; IBUPROFEN
Active strength 8 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 2022-12-31
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 · 4 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 2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
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 A204575-001 HYDROCODONE BITARTRATE AND IBUPROFEN HYDROCODONE BITARTRATE; IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2016-06-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A204575-001 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 A204575-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2016-06-02 84e616aacf4f…2026-08-18 06:07:40 2026-07 A204575-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2016-06-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204575-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2016-06-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204575-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2016-06-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204575-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2016-06-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204575-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2016-06-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204575-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2016-06-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204575-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2016-06-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204575-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2016-06-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204575-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2016-06-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204575-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2016-06-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204575-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2016-06-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204575-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2016-06-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204575-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2016-06-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204575-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2016-06-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204575-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2016-06-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204575-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2016-06-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204575-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2016-06-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204575-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2016-06-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204575-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2016-06-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204575-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2016-06-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204575-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2016-06-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A204575-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2016-06-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A204575-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2016-06-02 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A204575-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2016-06-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A204575-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2016-06-02 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A204575-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2016-06-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A204575-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2016-06-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A204575-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2016-06-02 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204575-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2016-06-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204575-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2016-06-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204575-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2016-06-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204575-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2016-06-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204575-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2016-06-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A204575-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2016-06-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A204575-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2016-06-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A204575-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2016-06-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A204575-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2016-06-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A204575-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2016-06-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A204575-001 HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG TABLET / ORAL AB 2016-06-02 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67296-1655-7 Hydrocodone Bitartrate and Ibuprofen 15 in 1 BOTTLE TABLET, FILM COATED 15 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67296-1655 HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [REDPHARM DRUG, INC.] 3 Legacy NDC, 1 package rows 20240810_8909cfeb-e928-82b5-e053-2995a90a71b8.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 Marketing start Marketing end Sample Exclude flag Status 67296-1655-7 67296165507 15 TABLET, FILM COATED in 1 BOTTLE (67296-1655-7) 2019-01-01 0000-00-00 No No Current