Acetaminophen

Product NDC: 63868-089
11-digit product format: 638680089
Labeler code: 63868
Product ID: 63868-089_5e31330b-4b84-469f-a933-059e77358c79
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Chain Drug Marketing Association Inc.
Application: ANDA076200
Marketing category: ANDA
Marketing start: 2002-04-30
Marketing end: 0000-00-00
Substance: ACETAMINOPHEN
Active strength: 650 mg/1
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	63868-089		D	Discontinued by firm	2026-08-03
excluded package	package	63868-089	63868-089-01	D	Discontinued by firm	2026-08-03
excluded package	package	63868-089	63868-089-50	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
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…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63868-089-01	EA - Each	63868-089	869e41ae-e2d1-4296-aed6-8dd405c76805	1	2013-02-13
63868-089-50	EA - Each	63868-089	fed29e98-20ff-4aa0-b36b-aace1c16384e	1	2013-02-13

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63868-089	ACETAMINOPHEN TABLET, FILM COATED, EXTENDED RELEASE [CHAIN DRUG MARKETING ASSOCIATION INC.]	3	Legacy NDC	20241228_fe4e9ec5-fa9c-4494-8516-ab477e0fa918.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

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
63868-089-01	63868008901	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63868-089-01)	2002-04-30	0000-00-00	No	No	Current
63868-089-50	63868008950	50 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63868-089-50)	2002-04-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Acetaminophen	Chain Drug Marketing Association Inc. \| Sun Pharmaceutical Industries Inc. \| Ohm Laboratories Inc.	2024-12-27	HUMAN OTC DRUG LABEL	3