Acetaminophen

Product NDC: 69842-930
11-digit product format: 698420930
Labeler code: 69842
Product ID: 69842-930_2a40710a-b57f-9b21-e063-6294a90ad09d
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: CVS Pharmacy
Application: ANDA078569
Marketing category: ANDA
Marketing start: 2012-12-21
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 42.

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`caaa826d4ba7…`
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…`

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
6f880abe-5284-42b0-9db6-b071444b197b	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69842-930-80	Acetaminophen	80 in 1 BOTTLE	TABLET, EXTENDED RELEASE	80		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69842-930	ACETAMINOPHEN TABLET, EXTENDED RELEASE [CVS PHARMACY]	3	Current NDC, Legacy NDC, 1 package rows	20241228_6f880abe-5284-42b0-9db6-b071444b197b.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 ndc (product): 69842-930
Acetaminophen	ACETAMINOPHEN	Walgreen Company	a1cec332-5802-4684-8b7f-6cb98da40e8b	2018-08-15	Warnings	Exact identifier application applno (ANDA): 078569 application number: ANDA078569

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	6f880abe-5284-42b0-9db6-b071444b197b	3
1148399	8 HR acetaminophen 650 MG Extended Release Oral Tablet	SCD	6f880abe-5284-42b0-9db6-b071444b197b	3
1148399	8 HR APAP 650 MG Extended Release Oral Tablet	SY	6f880abe-5284-42b0-9db6-b071444b197b	3
1148399	acetaminophen 650 MG 8 HR Extended Release Oral Tablet	SY	6f880abe-5284-42b0-9db6-b071444b197b	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
69842-930-80	69842093080	80 TABLET, EXTENDED RELEASE in 1 BOTTLE (69842-930-80)	2012-12-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Acetaminophen	CVS Pharmacy \| Ranbaxy Pharmaceuticals Inc. \| Ohm Laboratories Inc.	2024-12-27	HUMAN OTC DRUG LABEL	3