Acetaminophen Extended-Release Tablets, 650 mg

Product NDC: 25000-071
11-digit product format: 250000071
Labeler code: 25000
Product ID: 25000-071_9e2c09cd-1bd4-4a86-8911-ba904d8a76cb
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: MARKSANS PHARMA LIMITED
Application: ANDA215486
Marketing category: ANDA
Marketing start: 2021-09-02
Substance: ACETAMINOPHEN
Active strength: 650 mg/1
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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

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
2026-08-18 06:07:40	2026-07	A215486-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2021-08-25	`caaa826d4ba7…`
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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Acetaminophen Extended-Release Tablets, 650 mg
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	650 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
362O9ITL9D	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1148399	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
d973a910-5fe0-4a85-884d-2c3987836691	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
25000-071-02	Acetaminophen Extended-Release Tablets, 650 mg	1 in 1 CARTON	TABLET, EXTENDED RELEASE	1	5
25000-071-02	Acetaminophen Extended-Release Tablets, 650 mg	24 in 1 BOTTLE	TABLET, EXTENDED RELEASE	24	5
25000-071-08	Acetaminophen Extended-Release Tablets, 650 mg	1 in 1 CARTON	TABLET, EXTENDED RELEASE	1	5
25000-071-08	Acetaminophen Extended-Release Tablets, 650 mg	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100	5
25000-071-10	Acetaminophen Extended-Release Tablets, 650 mg	1 in 1 CARTON	TABLET, EXTENDED RELEASE	1	5
25000-071-10	Acetaminophen Extended-Release Tablets, 650 mg	225 in 1 BOTTLE	TABLET, EXTENDED RELEASE	225	5
25000-071-11	Acetaminophen Extended-Release Tablets, 650 mg	290 in 1 BOTTLE	TABLET, EXTENDED RELEASE	290	5
25000-071-11	Acetaminophen Extended-Release Tablets, 650 mg	1 in 1 CARTON	TABLET, EXTENDED RELEASE	1	5
25000-071-45	Acetaminophen Extended-Release Tablets, 650 mg	400 in 1 BOTTLE	TABLET, EXTENDED RELEASE	400	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
25000-071	ACETAMINOPHEN EXTENDED-RELEASE TABLETS, 650 MG (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [MARKSANS PHARMA LIMITED]	5	Current NDC, Legacy NDC, 9 package rows	20231019_d973a910-5fe0-4a85-884d-2c3987836691.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 ndc (product): 25000-071
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1148399	acetaminophen 650 MG 8HR Extended Release Oral Tablet	PSN	d973a910-5fe0-4a85-884d-2c3987836691	5
1148399	8 HR acetaminophen 650 MG Extended Release Oral Tablet	SCD	d973a910-5fe0-4a85-884d-2c3987836691	5
1148399	8 HR APAP 650 MG Extended Release Oral Tablet	SY	d973a910-5fe0-4a85-884d-2c3987836691	5
1148399	acetaminophen 650 MG 8 HR Extended Release Oral Tablet	SY	d973a910-5fe0-4a85-884d-2c3987836691	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
25000-071-02	25000007102	1 BOTTLE in 1 CARTON (25000-071-02) / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE	1 bottle	2021-09-02	0000-00-00	No	No	Current
25000-071-08	25000007108	1 BOTTLE in 1 CARTON (25000-071-08) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE	1 bottle	2021-09-02	0000-00-00	No	No	Current
25000-071-10	25000007110	1 BOTTLE in 1 CARTON (25000-071-10) / 225 TABLET, EXTENDED RELEASE in 1 BOTTLE	1 bottle	2021-09-02	0000-00-00	No	No	Current
25000-071-11	25000007111	1 BOTTLE in 1 CARTON (25000-071-11) / 290 TABLET, EXTENDED RELEASE in 1 BOTTLE	1 bottle	2021-09-02	0000-00-00	No	No	Current
25000-071-45	25000007145	400 TABLET, EXTENDED RELEASE in 1 BOTTLE (25000-071-45)		2021-09-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Arthritis Pain Relief Acetaminophen Extended-Release Tablets USP, 650 mg	MARKSANS PHARMA LIMITED	2023-10-17	Human OTC Drug Label	5