Acetaminophen

Product NDC: 53329-643
11-digit product format: 533290643
Labeler code: 53329
Product ID: 53329-643_4f1bbf5a-3e39-3618-e063-6394a90ac6c8
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Medline Industries, LP
Application: ANDA076200
Marketing category: ANDA
Marketing start: 2002-04-30
Marketing end: 2026-12-31
Substance: ACETAMINOPHEN
Active strength: 650 mg/1
NDC exclude flag: No
Current FDA listing: Yes

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
A076200-001	ACETAMINOPHEN	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL			2002-03-19

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 · 41 observed 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	A076200-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2002-03-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076200-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2002-03-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076200-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2002-03-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076200-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2002-03-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076200-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2002-03-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076200-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2002-03-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076200-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2002-03-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076200-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2002-03-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076200-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2002-03-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076200-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2002-03-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076200-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2002-03-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076200-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2002-03-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076200-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2002-03-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076200-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2002-03-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076200-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2002-03-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076200-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2002-03-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076200-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2002-03-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076200-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2002-03-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076200-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2002-03-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076200-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2002-03-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076200-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2002-03-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076200-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2002-03-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076200-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2002-03-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076200-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2002-03-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076200-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2002-03-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076200-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2002-03-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076200-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2002-03-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076200-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2002-03-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076200-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2002-03-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076200-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2002-03-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076200-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2002-03-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076200-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2002-03-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076200-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2002-03-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076200-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2002-03-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076200-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2002-03-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076200-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2002-03-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076200-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2002-03-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076200-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2002-03-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076200-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2002-03-19	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076200-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2002-03-19	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Acetaminophen

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
9f18d455-55ce-482c-8da8-dcb664038c6c	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53329-643-29	Acetaminophen	50 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	50		10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	ACETAMINOPHEN TABLET, FILM COATED, EXTENDED RELEASE [MEDLINE INDUSTRIES, INC.]	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	ACETAMINOPHEN TABLET, FILM COATED, EXTENDED RELEASE [MEDLINE INDUSTRIES, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ACETAMINOPHEN TABLET, FILM COATED, EXTENDED RELEASE [MEDLINE INDUSTRIES, INC.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ACETAMINOPHEN TABLET, FILM COATED, EXTENDED RELEASE [MEDLINE INDUSTRIES, INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ACETAMINOPHEN TABLET, FILM COATED, EXTENDED RELEASE [MEDLINE INDUSTRIES, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ACETAMINOPHEN TABLET, FILM COATED, EXTENDED RELEASE [MEDLINE INDUSTRIES, INC.]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	ACETAMINOPHEN TABLET, FILM COATED, EXTENDED RELEASE [MEDLINE INDUSTRIES, INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ACETAMINOPHEN TABLET, FILM COATED, EXTENDED RELEASE [MEDLINE INDUSTRIES, INC.]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	ACETAMINOPHEN TABLET, FILM COATED, EXTENDED RELEASE [MEDLINE INDUSTRIES, INC.]	1
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	ACETAMINOPHEN TABLET, FILM COATED, EXTENDED RELEASE [MEDLINE INDUSTRIES, INC.]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	ACETAMINOPHEN TABLET, FILM COATED, EXTENDED RELEASE [MEDLINE INDUSTRIES, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ACETAMINOPHEN TABLET, FILM COATED, EXTENDED RELEASE [MEDLINE INDUSTRIES, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53329-643	ACETAMINOPHEN TABLET, FILM COATED, EXTENDED RELEASE [MEDLINE INDUSTRIES, LP]	9	Current NDC, Legacy NDC, 1 package rows	20250114_9f18d455-55ce-482c-8da8-dcb664038c6c.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acetaminophen	ACETAMINOPHEN	Medline Industries, LP	9f18d455-55ce-482c-8da8-dcb664038c6c	2026-04-10	Warnings	Exact identifier application applno (ANDA): 076200 application number: ANDA076200 ndc (product): 53329-643

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	9f18d455-55ce-482c-8da8-dcb664038c6c	10
1148399	8 HR acetaminophen 650 MG Extended Release Oral Tablet	SCD	9f18d455-55ce-482c-8da8-dcb664038c6c	10
1148399	8 HR APAP 650 MG Extended Release Oral Tablet	SY	9f18d455-55ce-482c-8da8-dcb664038c6c	10
1148399	acetaminophen 650 MG 8 HR Extended Release Oral Tablet	SY	9f18d455-55ce-482c-8da8-dcb664038c6c	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
53329-643-29	53329064329	50 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (53329-643-29)	2018-07-10	2026-12-31	No	No	Current