Primlev

Product NDC: 24090-682
11-digit product format: 240900682
Labeler code: 24090
Product ID: 24090-682_a3e037f0-fa7c-ba94-e053-2a95a90ab250
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: oxycodone and acetaminophen
Dosage form: TABLET
Route: ORAL
Labeler: Akrimax Pharmaceuticals, LLC
Application: ANDA040608
Marketing category: ANDA
Marketing start: 2011-12-01
Marketing end: 2020-11-30
Substance: OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN
Active strength: 8 mg/1; mg/1
Pharmacologic classes: Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	24090-682		D	Discontinued by firm	2026-08-17
excluded package	package	24090-682	24090-682-85	D	Discontinued by firm	2026-08-17
excluded package	package	24090-682	24090-682-88	D	Discontinued by firm	2026-08-17

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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	24090-682-85	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	24090-682-88	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	24090-682-85	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	24090-682-88	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	24090-682-85	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	24090-682-88	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	24090-682-85	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	24090-682-88	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	24090-682-85	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	24090-682-88	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	24090-682-85	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	24090-682-88	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	24090-682-85	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	24090-682-88	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	24090-682-85	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	24090-682-88	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	24090-682-85	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	24090-682-88	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	24090-682-85	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	24090-682-88	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	24090-682-85	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	24090-682-88	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	24090-682-85	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	24090-682-88	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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	RLD / RS	Approval date
A040608-001	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	300MG;2.5MG	TABLET / ORAL	RS	2005-12-30
A040608-002	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	300MG;5MG	TABLET / ORAL	RS	2005-12-30
A040608-003	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	300MG;7.5MG	TABLET / ORAL	RS	2005-12-30
A040608-004	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	300MG;10MG	TABLET / ORAL	RS	2005-12-30

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 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A040608-001	OXYCODONE AND ACETAMINOPHEN	300MG;2.5MG	TABLET / ORAL	RS	2005-12-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040608-002	OXYCODONE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	RS	2005-12-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040608-003	OXYCODONE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL	RS	2005-12-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040608-004	OXYCODONE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL	RS	2005-12-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040608-001	OXYCODONE AND ACETAMINOPHEN	300MG;2.5MG	TABLET / ORAL	RS	2005-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040608-002	OXYCODONE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	RS	2005-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040608-003	OXYCODONE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL	RS	2005-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040608-004	OXYCODONE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL	RS	2005-12-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040608-001	OXYCODONE AND ACETAMINOPHEN	300MG;2.5MG	TABLET / ORAL	RS	2005-12-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040608-002	OXYCODONE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	RS	2005-12-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040608-003	OXYCODONE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL	RS	2005-12-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040608-004	OXYCODONE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL	RS	2005-12-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040608-001	OXYCODONE AND ACETAMINOPHEN	300MG;2.5MG	TABLET / ORAL	RS	2005-12-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040608-002	OXYCODONE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	RS	2005-12-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040608-003	OXYCODONE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL	RS	2005-12-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040608-004	OXYCODONE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL	RS	2005-12-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040608-001	OXYCODONE AND ACETAMINOPHEN	300MG;2.5MG	TABLET / ORAL	RS	2005-12-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040608-002	OXYCODONE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	RS	2005-12-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040608-003	OXYCODONE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL	RS	2005-12-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040608-004	OXYCODONE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL	RS	2005-12-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040608-001	OXYCODONE AND ACETAMINOPHEN	300MG;2.5MG	TABLET / ORAL	RS	2005-12-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040608-002	OXYCODONE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	RS	2005-12-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040608-003	OXYCODONE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL	RS	2005-12-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040608-004	OXYCODONE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL	RS	2005-12-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040608-001	OXYCODONE AND ACETAMINOPHEN	300MG;2.5MG	TABLET / ORAL	RS	2005-12-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040608-002	OXYCODONE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	RS	2005-12-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040608-003	OXYCODONE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL	RS	2005-12-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040608-004	OXYCODONE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL	RS	2005-12-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040608-001	OXYCODONE AND ACETAMINOPHEN	300MG;2.5MG	TABLET / ORAL	RS	2005-12-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040608-002	OXYCODONE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	RS	2005-12-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040608-003	OXYCODONE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL	RS	2005-12-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040608-004	OXYCODONE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL	RS	2005-12-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040608-001	OXYCODONE AND ACETAMINOPHEN	300MG;2.5MG	TABLET / ORAL	RS	2005-12-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040608-002	OXYCODONE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	RS	2005-12-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040608-003	OXYCODONE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL	RS	2005-12-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040608-004	OXYCODONE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL	RS	2005-12-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040608-001	OXYCODONE AND ACETAMINOPHEN	300MG;2.5MG	TABLET / ORAL	RS	2005-12-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040608-002	OXYCODONE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	RS	2005-12-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040608-003	OXYCODONE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL	RS	2005-12-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040608-004	OXYCODONE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL	RS	2005-12-30	`d8e5a09893c0…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
24090-682-85	EA - Each	24090-682	9362b6cc-468c-444a-b549-6602a0202eb3	1	2013-02-13
24090-682-88	EA - Each	24090-682	5579aa1e-37d6-4519-a80c-c50f2478967b	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	PRIMLEV (OXYCODONE AND ACETAMINOPHEN) TABLET [AKRIMAX PHARMACEUTICALS, LLC]	4
OXYCODONE HYDROCHLORIDE	ACTIVE INGREDIENT	C1ENJ2TE6C	PRIMLEV (OXYCODONE AND ACETAMINOPHEN) TABLET [AKRIMAX PHARMACEUTICALS, LLC]	4
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	PRIMLEV (OXYCODONE AND ACETAMINOPHEN) TABLET [AKRIMAX PHARMACEUTICALS, LLC]	4
OXYCODONE	ACTIVE MOIETY	CD35PMG570	PRIMLEV (OXYCODONE AND ACETAMINOPHEN) TABLET [AKRIMAX PHARMACEUTICALS, LLC]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PRIMLEV (OXYCODONE AND ACETAMINOPHEN) TABLET [AKRIMAX PHARMACEUTICALS, LLC]	4
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	PRIMLEV (OXYCODONE AND ACETAMINOPHEN) TABLET [AKRIMAX PHARMACEUTICALS, LLC]	4
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	PRIMLEV (OXYCODONE AND ACETAMINOPHEN) TABLET [AKRIMAX PHARMACEUTICALS, LLC]	4
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	PRIMLEV (OXYCODONE AND ACETAMINOPHEN) TABLET [AKRIMAX PHARMACEUTICALS, LLC]	4
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	PRIMLEV (OXYCODONE AND ACETAMINOPHEN) TABLET [AKRIMAX PHARMACEUTICALS, LLC]	4
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	PRIMLEV (OXYCODONE AND ACETAMINOPHEN) TABLET [AKRIMAX PHARMACEUTICALS, LLC]	4
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	PRIMLEV (OXYCODONE AND ACETAMINOPHEN) TABLET [AKRIMAX PHARMACEUTICALS, LLC]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PRIMLEV (OXYCODONE AND ACETAMINOPHEN) TABLET [AKRIMAX PHARMACEUTICALS, LLC]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PRIMLEV (OXYCODONE AND ACETAMINOPHEN) TABLET [AKRIMAX PHARMACEUTICALS, LLC]	4
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	PRIMLEV (OXYCODONE AND ACETAMINOPHEN) TABLET [AKRIMAX PHARMACEUTICALS, LLC]	4

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nalocet	OXYCODONE AND ACETAMINOPHEN	Forte Bio-Pharma LLC	f5f7dfca-a5c7-4445-8a5e-9ec62f33f5be	2026-08-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040608 application number: ANDA040608
oxycodone and acetaminophen	OXYCODONE AND ACETAMINOPHEN	FH2 Pharma LLC	88d97caf-bcf5-3cde-e053-2995a90acf4a	2026-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040608 application number: ANDA040608
Prolate	OXYCODONE AND ACETAMINOPHEN	Forte Bio-Pharma LLC	9cbbfa94-37b9-9652-e053-2995a90a736b	2026-05-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040608 application number: ANDA040608

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
C1ENJ2TE6C	OXYCODONE HYDROCHLORIDE	124-90-3	OXYCODONE HYDROCHLORIDE
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Primlev - Akrimax Pharmaceuticals, LLC	Akrimax Pharmaceuticals, LLC	2020-04-22	HUMAN PRESCRIPTION DRUG LABEL	13