8 HR Arthritis Pain

Product NDC: 75907-430
11-digit product format: 759070430
Labeler code: 75907
Product ID: 75907-430_2b89d8dc-aa00-5564-20a9-269c26d7d14f
Type: HUMAN OTC DRUG
Nonproprietary name: ACETAMINOPHEN
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Dr. Reddy's Laboratories Inc.
Application: ANDA211544
Marketing category: ANDA
Marketing start: 2026-07-01
Substance: ACETAMINOPHEN
Active strength: 650 mg/1
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A211544-001	ACETAMINOPHEN	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL			2019-04-16

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 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: 8 HR Arthritis Pain
Listing expiration: 2027-12-31

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
8e780c23-997c-b960-226e-954037baad4b	Available on FDA.report

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 3 of 3 · 55 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ACETAMINOPHEN	ACETAMINOPHEN	GERI-CARE PHARMACEUTICAL CORP	92c22593-daf9-20a8-e053-2a95a90a365d	2024-07-23	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
8 Hour Pain Relief	ACETAMINOPHEN	CHAIN DRUG MARKETING ASSOCIATION, INC.	3ec966f5-bdcb-4bd8-b265-c776ba778f25	2024-06-13	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
8 Hour Arthritis Pain	ACETAMINOPHEN	CHAIN DRUG MARKETING ASSOCIATION, INC.	b098ebf6-a76d-4550-b5c4-fdc3b4ceb9a8	2024-06-13	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
8HR Muscle Aches and Pain	ACETAMINOPHEN	AAA Pharmaceutical, Inc.	15abb899-e301-40e6-e063-6294a90a4bac	2024-06-13	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
8HR Muscle Aches and Pain	ACETAMINOPHEN	FSA STORE INC.	13268603-0080-22cf-e063-6394a90a7db4	2024-06-13	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
Pain Relief	PAIN RELIEF	Allegiant Health	f4720346-c3e0-4707-b007-1bf1f5e05707	2024-04-24	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
8 Hour Arthritis Pain	ACETAMINOPHEN	MARC GLASSMAN, INC.	e2387b9c-94c0-397a-e053-2995a90a444c	2023-11-02	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
8 Hour Arthritis Pain	ACETAMINOPHEN	AMERISOURCE BERGEN	7888eff3-3030-4aa0-89e3-9795aa214659	2023-10-31	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
DOLO - NeuroBion Acetaminophen Max Extended-Release 650 mg	ACETAMINOPHEN	BENARD INDUSTRIES INC	eaa9d094-ece6-41fd-97d9-0fdb0a45afd7	2023-06-19	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
8 Hour Pain Relief	ACETAMINOPHEN	STRATEGIC SOURCING SERVICES LLC	c003a34a-bfe5-4298-8a4e-8c75576f5674	2023-06-09	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
eight hour pain relief	ACETAMINOPHEN	United Natural Foods, Inc. dba UNFI	b5fe8873-13c9-402e-b06c-6e679af7267e	2023-05-17	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
HEB	ACETAMINOPHEN	HEB	96b1808f-defa-28cb-e053-2995a90a563b	2023-04-12	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
Arthritis Pain Relief	ACETAMINOPHEN	WINCO FOODS, LLC	f45f43da-b994-2bc8-e053-2995a90a93e0	2023-04-11	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
Arthritis Pain Relief	ACETAMINOPHEN	TOPCO ASSOCIATES LLC	e60aa992-f5f7-3506-e053-2995a90a7abd	2022-10-04	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
Acetaminophen Extended-Release	ACETAMINOPHEN	Magno-Humphries, Inc.	9d22bedb-9fc9-8421-e053-2a95a90acf4a	2021-10-28	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544

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	Sample	Exclude flag	Status
75907-430-01	75907043001	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (75907-430-01)	2026-07-01	No	No	Current
75907-430-40	75907043040	400 TABLET, EXTENDED RELEASE in 1 BOTTLE (75907-430-40)	2026-07-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Acetaminophen Extended Release Tablets USP, 650 mg	Dr. Reddy's Laboratories Inc. \| Granules India Limited	2026-07-01	HUMAN OTC DRUG LABEL	1