Hydrocodone Bitartrate and Ibuprofen

Product NDC
67296-1655
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct67296-1655IInactivated by FDA2026-10-05
excluded packagepackage67296-165567296-1655-7IInactivated by FDA2026-10-05

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 · 8 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67296-1655-7557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage67296-1655-78af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage67296-1655-7834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage67296-1655-71332a3947898…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204575-001HYDROCODONE BITARTRATE AND IBUPROFENHYDROCODONE BITARTRATE; IBUPROFEN7.5MG;200MGTABLET / ORALAB2016-06-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A204575-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A204575-001HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORALAB2016-06-0284e616aacf4f…
2026-08-18 06:07:402026-07A204575-001HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORALAB2016-06-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204575-001HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORALAB2016-06-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204575-001HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORALAB2016-06-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A204575-001HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORALAB2016-06-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204575-001HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORALAB2016-06-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204575-001HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORALAB2016-06-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204575-001HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORALAB2016-06-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204575-001HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORALAB2016-06-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204575-001HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORALAB2016-06-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204575-001HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORALAB2016-06-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204575-001HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORALAB2016-06-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204575-001HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORALAB2016-06-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204575-001HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORALAB2016-06-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204575-001HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORALAB2016-06-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204575-001HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORALAB2016-06-028072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204575-001HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORALAB2016-06-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204575-001HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORALAB2016-06-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204575-001HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORALAB2016-06-024b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A204575-001HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORALAB2016-06-0274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A204575-001HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORALAB2016-06-02bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A204575-001HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORALAB2016-06-02782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A204575-001HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORALAB2016-06-0287673890dc5c…
2021-03-12 10:30 UTC2021-03A204575-001HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORALAB2016-06-025aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A204575-001HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORALAB2016-06-028869cabd3fbd…
2020-11-12 02:37 UTC2020-11A204575-001HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORALAB2016-06-02c0c555d07b60…
2019-12-14 00:12 UTC2019-12A204575-001HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORALAB2016-06-023f01610625f2…
2019-09-15 20:21 UTC2019-09A204575-001HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORALAB2016-06-02b00525d2431f…
2019-07-19 19:46 UTC2019-07A204575-001HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORALAB2016-06-02ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A204575-001HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORALAB2016-06-026a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A204575-001HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORALAB2016-06-021c564ffb4f44…
2023-12-20 04:57 UTC2023-12A204575-001HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORALAB2016-06-02ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A204575-001HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORALAB2016-06-02a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A204575-001HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORALAB2016-06-029b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A204575-001HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORALAB2016-06-02a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A204575-001HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORALAB2016-06-023f0d92c62455…
2023-05-13 08:27 UTC2023-05A204575-001HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORALAB2016-06-02053a50430f4f…
2023-01-26 05:58 UTC2023-01A204575-001HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORALAB2016-06-023bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A204575-001HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORALAB2016-06-023a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A204575-001HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORALAB2016-06-02f41ea6bd6efb…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A204575-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A204575-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204575-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204575-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204575-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204575-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204575-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204575-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204575-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204575-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204575-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204575-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204575-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204575-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204575-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204575-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204575-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204575-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204575-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A204575-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A204575-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A204575-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A204575-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A204575-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A204575-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A204575-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A204575-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A204575-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A204575-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A204575-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A204575-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A204575-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A204575-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A204575-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A204575-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A204575-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A204575-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A204575-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A204575-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A204575-001AB1f41ea6bd6efb…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
53523715-c529-4d52-b9ff-1e5d76636f53Product name220210818
31b11e56-5b35-4ab6-a3a8-f0b48973dcedProduct name220200611
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
7855f8e3-562e-4273-8b79-0059c07a71f7Product name120170901
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
a5244f9c-cd67-0e27-d63b-65fd7e584400Product name220170504
b654f2d9-ebeb-451d-96ee-22f583344623Product name120170424
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67296-1655-72024-08-09C16284748780-1f386c64a-37f0-0266-e053-dadaa90a7c1aHYDROCODONE/IBU 7.5/200mg
67296-1655-72023-01-30C16284748780-1f386c64a-37f0-0266-e053-dadaa90a7c1aHYDROCODONE/IBU 7.5/200mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1655-7Hydrocodone Bitartrate and Ibuprofen15 in 1 BOTTLETABLET, FILM COATED153

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1655HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [REDPHARM DRUG, INC.]3Legacy NDC, 1 package rows20240810_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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrocodone Bitartrate and IbuprofenHYDROCODONE BITARTRATE AND IBUPROFENAurolife Pharma, LLC470df63a-5c0f-42df-9023-a330a901153e2025-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204575
application number: ANDA204575

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858798HYDROcodone bitartrate 7.5 MG / ibuprofen 200 MG Oral TabletPSN8909cfeb-e928-82b5-e053-2995a90a71b83
858798hydrocodone bitartrate 7.5 MG / ibuprofen 200 MG Oral TabletSCD8909cfeb-e928-82b5-e053-2995a90a71b83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67296-1655-76729616550715 TABLET, FILM COATED in 1 BOTTLE (67296-1655-7) 2019-01-010000-00-00NoNoCurrent