Hydrocodone Bitartrate and Ibuprofen

Product NDC: 68084-841
Requested package NDC: 68084-841-01
11-digit product format: 680840841
Labeler code: 68084
Product ID: 68084-841_ec1a8451-4cc9-5e13-e053-2a95a90a3376
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydrocodone Bitartrate and Ibuprofen
Dosage form: TABLET
Route: ORAL
Labeler: American Health Packaging
Application: ANDA076642
Marketing category: ANDA
Marketing start: 2014-09-24
Marketing end: 0000-00-00
Substance: HYDROCODONE BITARTRATE; IBUPROFEN
Active strength: 8 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

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68084-841	68084-841-01	D	Discontinued by firm		2026-10-05

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 · 11 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…`

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A076642-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076642-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076642-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076642-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076642-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076642-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076642-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076642-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076642-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076642-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076642-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076642-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076642-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076642-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076642-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076642-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076642-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076642-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076642-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076642-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076642-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076642-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076642-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076642-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076642-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076642-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076642-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076642-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076642-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076642-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076642-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076642-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076642-004	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076642-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076642-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076642-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076642-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076642-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076642-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076642-001	AB	1	`5aa47cf7b7d7…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68084-841-01	EA - Each	68084-841	bb1b46b2-2feb-4ee8-8881-cff450a40641	1	2015-03-03
68084-841-09	EA - Each	68084-841	0d3c3338-c295-4477-9863-e7c0e9c00569	1	2014-11-05
68084-841-11	EA - Each	68084-841	4e3c646a-b599-4ebe-8cb4-2cb4e5cbbec2	1	2014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROCODONE BITARTRATE	ACTIVE INGREDIENT	NO70W886KK	HYDROCODONE BITARTRATE AND IBUPROFEN TABLET [AMERICAN HEALTH PACKAGING]	3
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	HYDROCODONE BITARTRATE AND IBUPROFEN TABLET [AMERICAN HEALTH PACKAGING]	3
HYDROCODONE	ACTIVE MOIETY	6YKS4Y3WQ7	HYDROCODONE BITARTRATE AND IBUPROFEN TABLET [AMERICAN HEALTH PACKAGING]	3
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	HYDROCODONE BITARTRATE AND IBUPROFEN TABLET [AMERICAN HEALTH PACKAGING]	3
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	HYDROCODONE BITARTRATE AND IBUPROFEN TABLET [AMERICAN HEALTH PACKAGING]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	HYDROCODONE BITARTRATE AND IBUPROFEN TABLET [AMERICAN HEALTH PACKAGING]	3
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	HYDROCODONE BITARTRATE AND IBUPROFEN TABLET [AMERICAN HEALTH PACKAGING]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	HYDROCODONE BITARTRATE AND IBUPROFEN TABLET [AMERICAN HEALTH PACKAGING]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROCODONE BITARTRATE AND IBUPROFEN TABLET [AMERICAN HEALTH PACKAGING]	3
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	HYDROCODONE BITARTRATE AND IBUPROFEN TABLET [AMERICAN HEALTH PACKAGING]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	HYDROCODONE BITARTRATE AND IBUPROFEN TABLET [AMERICAN HEALTH PACKAGING]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	HYDROCODONE BITARTRATE AND IBUPROFEN TABLET [AMERICAN HEALTH PACKAGING]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	HYDROCODONE BITARTRATE AND IBUPROFEN TABLET [AMERICAN HEALTH PACKAGING]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	HYDROCODONE BITARTRATE AND IBUPROFEN TABLET [AMERICAN HEALTH PACKAGING]	3

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrocodone Bitartrate and Ibuprofen	HYDROCODONE BITARTRATE AND IBUPROFEN	Amneal Pharmaceuticals of New York LLC	abc33718-4e88-43ea-9ffa-2b04ffc812ef	2025-11-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076642 application number: ANDA076642

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
NO70W886KK	HYDROCODONE BITARTRATE	34195-34-1	HYDROCODONE BITARTRATE
WK2XYI10QM	IBUPROFEN	15687-27-1	IBUPROFEN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68084-841-01	68084084101	100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-841-01) > 1 TABLET in 1 BLISTER PACK (68084-841-11)	100 blister pack	2015-02-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydrocodone Bitartrate and Ibuprofen Tablets (CII) Rx only 8284109/0822F	American Health Packaging	2023-07-06	HUMAN PRESCRIPTION DRUG LABEL	11