Acetaminophen

Product NDC: 0615-8425
11-digit product format: 006158425
Labeler code: 0615
Product ID: 0615-8425_bbf70b51-014e-4b1a-b35e-94421d6d8bec
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: NCS HealthCare of KY, LLC dba Vangard Labs
Application: ANDA215486
Marketing category: ANDA
Marketing start: 2021-10-04
Marketing end: 0000-00-00
Substance: ACETAMINOPHEN
Active strength: 650 mg/1
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0615-8425		D	Discontinued by firm		2026-08-03
excluded package	package	0615-8425	0615-8425-39	D	Discontinued by firm		2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A215486-001	ACETAMINOPHEN	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL			2021-08-25

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A215486-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2021-08-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215486-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2021-08-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215486-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2021-08-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215486-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2021-08-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215486-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2021-08-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215486-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2021-08-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215486-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2021-08-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215486-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2021-08-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215486-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2021-08-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215486-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2021-08-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215486-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2021-08-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215486-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2021-08-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215486-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2021-08-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215486-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2021-08-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215486-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2021-08-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215486-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2021-08-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A215486-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2021-08-25	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A215486-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2021-08-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A215486-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2021-08-25	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215486-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2021-08-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215486-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2021-08-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215486-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2021-08-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215486-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2021-08-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215486-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2021-08-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215486-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2021-08-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215486-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2021-08-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215486-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2021-08-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215486-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2021-08-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215486-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2021-08-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215486-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2021-08-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215486-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2021-08-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A215486-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2021-08-25	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215486-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2021-08-25	`a50c72e98297…`

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0615-8425	ACETAMINOPHEN TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]	3	Legacy NDC	20240625_d580b9c5-1999-4156-9bda-9bf87302fa62.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 · 18 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
8HR Arthritis Pain Relief	ACETAMINOPHEN 650MG	CVS Pharmacy	2eb6eba1-46af-32a4-e063-6294a90a499c	2026-04-28	Warnings	Exact identifier application applno (ANDA): 215486 application number: ANDA215486
Arthritis Pain	ACETAMINOPHEN	SAM'S WEST INC	3928090d-b45e-6948-e063-6394a90a47dd	2025-08-11	Warnings	Exact identifier application applno (ANDA): 215486 application number: ANDA215486
8HR Arthritis Pain Relief	ACETAMINOPHEN	LEADER/ Cardinal Health 110, Inc.	331f907a-0fb6-e23d-e063-6394a90a2db1	2025-06-22	Warnings	Exact identifier application applno (ANDA): 215486 application number: ANDA215486
8HR Muscle Aches and Pain Relief	ACETAMINOPHEN	LEADER/ Cardinal Health 110, Inc.	331f4bd1-1303-cc48-e063-6394a90a74d3	2025-06-03	Warnings	Exact identifier application applno (ANDA): 215486 application number: ANDA215486
Arthritis Pain Relief	ACETAMINOPHEN	KROGER COMPANY	0fec22a3-aad0-8c28-e063-6394a90adc18	2025-05-10	Warnings	Exact identifier application applno (ANDA): 215486 application number: ANDA215486
8hr arthritis pain relief	ACETAMINOPHEN	Major Pharmaceuticals	31b3aaa2-8af2-670a-e063-6394a90a8003	2025-05-03	Warnings	Exact identifier application applno (ANDA): 215486 application number: ANDA215486
8 HR MUSCLE ACHES AND PAIN	ACETAMINOPHEN	CVS Pharmacy	2eb6fc42-6ba4-8f58-e063-6294a90ac6a0	2025-04-28	Warnings	Exact identifier application applno (ANDA): 215486 application number: ANDA215486
Acetaminophen	ACETAMINOPHEN TABLET EXTENDED RELEASE	Asclemed USA, Inc.	4ef6bc2b-03cf-474f-bb9e-dbb5792ec197	2025-02-24	Warnings	Exact identifier application applno (ANDA): 215486 application number: ANDA215486
8 Hour Pain Relief	ACETAMINOPHEN	KROGER COMPANY	0fec5c67-8d5d-8e45-e063-6394a90a982a	2024-04-15	Warnings	Exact identifier application applno (ANDA): 215486 application number: ANDA215486
Acetaminophen	ACETAMINOPHEN TABLET EXTENDED RELEASE	Bryant Ranch Prepack	61ea1796-b9c7-4cb9-9a36-60943f884875	2024-04-05	Warnings	Exact identifier application applno (ANDA): 215486 application number: ANDA215486
Acetaminophen	ACETAMINOPHEN TABLET EXTENDED RELEASE	TIME CAP LABORATORIES, INC.	cd4d0ad4-7206-94c8-e053-2a95a90aaa14	2024-03-19	Warnings	Exact identifier application applno (ANDA): 215486 application number: ANDA215486
Arthritis Pain Acetaminophen	ACETAMINOPHEN	TARGET CORPORATION	c8025c83-77a1-c0dd-e053-2995a90a838d	2024-03-15	Warnings	Exact identifier application applno (ANDA): 215486 application number: ANDA215486
8HR Pain Relief	ACETAMINOPHEN	TARGET CORPORATION	e8b48f37-6023-ba04-e053-2a95a90a0e6c	2024-03-15	Warnings	Exact identifier application applno (ANDA): 215486 application number: ANDA215486
Arthritis Pain Reliever	ACETAMINOPHEN	WALGREENS	e71f632f-37dd-49c0-e053-2a95a90a67d7	2024-03-15	Warnings	Exact identifier application applno (ANDA): 215486 application number: ANDA215486
Acetaminophen Extended-Release Tablets, 650 mg	ACETAMINOPHEN	MARKSANS PHARMA LIMITED	d973a910-5fe0-4a85-884d-2c3987836691	2023-10-17	Warnings	Exact identifier application applno (ANDA): 215486 application number: ANDA215486
Arthritis Pain	ACETAMINOPHEN	BETTER LIVING BRANDS, LLC	ee84323a-b615-3ec6-e053-2995a90a5a26	2023-06-15	Warnings	Exact identifier application applno (ANDA): 215486 application number: ANDA215486
8 hr Arthritis Pain Relief	ACETAMINOPHEN	DOLGENCORP, INC.	ea2eae7c-e9bd-534c-e053-2a95a90a26c8	2023-04-20	Warnings	Exact identifier application applno (ANDA): 215486 application number: ANDA215486
8 hr Pain Relief	ACETAMINOPHEN	DOLGENCORP, INC.	ea2ebb7b-ceab-567a-e053-2995a90aa402	2023-04-20	Warnings	Exact identifier application applno (ANDA): 215486 application number: ANDA215486

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0615-8425-39	00615842539	30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-8425-39)	2022-02-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Timely 699R Arthritis Pain Relief- Acetaminophen Extended-Release Tablets USP, 650 mg	NCS HealthCare of KY, LLC dba Vangard Labs \| MARKSANS PHARMA LIMITED	2024-06-21	HUMAN OTC DRUG LABEL	4