Acetaminophen

Product NDC: 0363-0340
11-digit product format: 003630340
Labeler code: 0363
Product ID: 0363-0340_1bc5ce72-38f4-43f7-99cc-2b8b4725e15b
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Walgreen Company
Application: ANDA078569
Marketing category: ANDA
Marketing start: 2016-05-01
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 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
A078569-001	ACETAMINOPHEN	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL			2011-12-14

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	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Acetaminophen
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
a1cec332-5802-4684-8b7f-6cb98da40e8b	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0363-0340-08	Acetaminophen	80 in 1 BOTTLE	TABLET, EXTENDED RELEASE	80		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0363-0340-08	EA - Each	0363-0340	d0be207a-dbd3-4ae2-a6f3-8be74791c47e	1	2022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	ACETAMINOPHEN TABLET, EXTENDED RELEASE [WALGREEN COMPANY]	2
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	ACETAMINOPHEN TABLET, EXTENDED RELEASE [WALGREEN COMPANY]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ACETAMINOPHEN TABLET, EXTENDED RELEASE [WALGREEN COMPANY]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ACETAMINOPHEN TABLET, EXTENDED RELEASE [WALGREEN COMPANY]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	ACETAMINOPHEN TABLET, EXTENDED RELEASE [WALGREEN COMPANY]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	ACETAMINOPHEN TABLET, EXTENDED RELEASE [WALGREEN COMPANY]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ACETAMINOPHEN TABLET, EXTENDED RELEASE [WALGREEN COMPANY]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ACETAMINOPHEN TABLET, EXTENDED RELEASE [WALGREEN COMPANY]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ACETAMINOPHEN TABLET, EXTENDED RELEASE [WALGREEN COMPANY]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ACETAMINOPHEN TABLET, EXTENDED RELEASE [WALGREEN COMPANY]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ACETAMINOPHEN TABLET, EXTENDED RELEASE [WALGREEN COMPANY]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	ACETAMINOPHEN TABLET, EXTENDED RELEASE [WALGREEN COMPANY]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ACETAMINOPHEN TABLET, EXTENDED RELEASE [WALGREEN COMPANY]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	ACETAMINOPHEN TABLET, EXTENDED RELEASE [WALGREEN COMPANY]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ACETAMINOPHEN TABLET, EXTENDED RELEASE [WALGREEN COMPANY]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ACETAMINOPHEN TABLET, EXTENDED RELEASE [WALGREEN COMPANY]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0363-0340	ACETAMINOPHEN TABLET, EXTENDED RELEASE [WALGREEN COMPANY]	4	Current NDC, Legacy NDC, 1 package rows	20180817_a1cec332-5802-4684-8b7f-6cb98da40e8b.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acetaminophen	ACETAMINOPHEN	CVS Pharmacy	6f880abe-5284-42b0-9db6-b071444b197b	2024-12-27	Warnings	Exact identifier application applno (ANDA): 078569 application number: ANDA078569
Acetaminophen	ACETAMINOPHEN	Walgreen Company	a1cec332-5802-4684-8b7f-6cb98da40e8b	2018-08-15	Warnings	Exact identifier application applno (ANDA): 078569 application number: ANDA078569 ndc (product): 0363-0340

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	a1cec332-5802-4684-8b7f-6cb98da40e8b	4
1148399	8 HR acetaminophen 650 MG Extended Release Oral Tablet	SCD	a1cec332-5802-4684-8b7f-6cb98da40e8b	4
1148399	8 HR APAP 650 MG Extended Release Oral Tablet	SY	a1cec332-5802-4684-8b7f-6cb98da40e8b	4
1148399	acetaminophen 650 MG 8 HR Extended Release Oral Tablet	SY	a1cec332-5802-4684-8b7f-6cb98da40e8b	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0363-0340-08	00363034008	80 TABLET, EXTENDED RELEASE in 1 BOTTLE (0363-0340-08)	2016-05-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Acetaminophen	Walgreen Company \| Ranbaxy Pharmaceuticals Inc. \| Ohm Laboratories Inc.	2018-08-15	HUMAN OTC DRUG LABEL	4