Hydrocodone Bitartrate and Ibuprofen

Product NDC: 0603-3584
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

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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0603-3584		D	Discontinued by firm		2026-08-03
excluded package	package	0603-3584	0603-3584-21	D	Discontinued by firm		2026-08-03

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	0603-3584		D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0603-3584	0603-3584-21	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product	0603-3584		D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0603-3584	0603-3584-21	D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product	0603-3584		D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0603-3584	0603-3584-21	D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product	0603-3584		D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0603-3584	0603-3584-21	D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product	0603-3584		D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0603-3584	0603-3584-21	D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product	0603-3584		D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0603-3584	0603-3584-21	D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product	0603-3584		D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0603-3584	0603-3584-21	D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product	0603-3584		D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0603-3584	0603-3584-21	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	0603-3584		D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0603-3584	0603-3584-21	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product	0603-3584		D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0603-3584	0603-3584-21	D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product	0603-3584		D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0603-3584	0603-3584-21	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product	0603-3584		D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0603-3584	0603-3584-21	D	Discontinued by firm	excluded / ndc_excluded.zip	`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	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#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A077727-001	AB	1	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	A077727-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077727-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077727-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077727-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077727-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077727-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077727-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077727-001	AB	1	`ea99ee380514…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0603-3584-21	EA - Each	0603-3584	d9f5d205-f929-417e-85a1-45a7b02e4f13	1	2015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
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

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	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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydrocodone Bitartrate and Ibuprofen Tablets 5 mg/200 mg, 7.5 mg/200 mg and 10 mg/200 mg	Par Pharmaceutical, Inc.	2019-08-15	HUMAN PRESCRIPTION DRUG LABEL	14