Acetaminophen-APAP 8 Hour

Product NDC: 41520-336
11-digit product format: 415200336
Labeler code: 41520
Product ID: 41520-336_a833a491-7e96-4c0e-b534-38f757335f9e
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: American Sales Company
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: 2019-12-31
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	41520-336		I	Inactivated by FDA		2026-08-03
excluded package	package	41520-336	41520-336-23	I	Inactivated by FDA		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 42 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	41520-336-23	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	41520-336-23	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	41520-336-23	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	41520-336-23	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	41520-336-23	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	41520-336-23	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	41520-336-23	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	41520-336-23	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	41520-336-23	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	41520-336-23	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	41520-336-23	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	41520-336-23	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	41520-336-23	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	41520-336-23	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	41520-336-23	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	41520-336-23	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	41520-336-23	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	41520-336-23	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	41520-336-23	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	41520-336-23	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	41520-336-23	`9bebd1f3094a…`	`5416666fcb17…`

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…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
41520-336-23	2020-01-31	C162847	48780-1	9d75b9d1-174f-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
41520-336-23	Acetaminophen-APAP 8 Hour	24 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	24		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	ACETAMINOPHEN-APAP 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN SALES COMPANY]	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	ACETAMINOPHEN-APAP 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN SALES COMPANY]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ACETAMINOPHEN-APAP 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN SALES COMPANY]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ACETAMINOPHEN-APAP 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN SALES COMPANY]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ACETAMINOPHEN-APAP 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN SALES COMPANY]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ACETAMINOPHEN-APAP 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN SALES COMPANY]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	ACETAMINOPHEN-APAP 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN SALES COMPANY]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ACETAMINOPHEN-APAP 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN SALES COMPANY]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	ACETAMINOPHEN-APAP 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN SALES COMPANY]	1
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	ACETAMINOPHEN-APAP 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN SALES COMPANY]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	ACETAMINOPHEN-APAP 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN SALES COMPANY]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ACETAMINOPHEN-APAP 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN SALES COMPANY]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41520-336	ACETAMINOPHEN-APAP 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN SALES COMPANY]	1	Legacy NDC, 1 package rows	20130211_d8259f15-ef0f-41bf-a038-0be4eacb2d79.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

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	d8259f15-ef0f-41bf-a038-0be4eacb2d79	1
1148399	8 HR acetaminophen 650 MG Extended Release Oral Tablet	SCD	d8259f15-ef0f-41bf-a038-0be4eacb2d79	1
1148399	8 HR APAP 650 MG Extended Release Oral Tablet	SY	d8259f15-ef0f-41bf-a038-0be4eacb2d79	1
1148399	acetaminophen 650 MG 8 HR Extended Release Oral Tablet	SY	d8259f15-ef0f-41bf-a038-0be4eacb2d79	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
41520-336-23	41520033623	24 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	American Sales Company \| Ranbaxy Pharmaceuticals Inc. \| Ohm Laboratories Inc.	2013-01-17	HUMAN OTC DRUG LABEL	1