Acetaminophen

Product NDC: 68016-183
Requested package NDC: 68016-183-10
11-digit product format: 680160183
Labeler code: 68016
Product ID: 68016-183_b7b4bf85-8a0e-4b0f-e053-2a95a90abf05
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: PHARMACY VALUE ALLIANCE, LLC
Application: ANDA211544
Marketing category: ANDA
Marketing start: 2019-11-15
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68016-183	68016-183-10	I	Inactivated by FDA		2026-08-17

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 · 16 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`
2020-12-18 03:04 UTC · source 2020-12-17	`e2bbac7714bc…`	`27bdfed8d636…`

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
A211544-001	ACETAMINOPHEN	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL			2019-04-16

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	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`e64feba35796…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
68016-183-05	2023-01-30	Arthitis Pain Acetaminophen Extended-release Tablets USP, 650 mg Pain Reliever / Fever Reducer For Temporary Relef of Minor Arthritis Pain Contains No Aspirin
68016-183-10	2023-01-30	Arthitis Pain Acetaminophen Extended-release Tablets USP, 650 mg Pain Reliever / Fever Reducer For Temporary Relef of Minor Arthritis Pain Contains No Aspirin
68016-183-05	2020-12-30	Arthitis Pain Acetaminophen Extended-release Tablets USP, 650 mg Pain Reliever / Fever Reducer For Temporary Relef of Minor Arthritis Pain Contains No Aspirin
68016-183-10	2020-12-30	Arthitis Pain Acetaminophen Extended-release Tablets USP, 650 mg Pain Reliever / Fever Reducer For Temporary Relef of Minor Arthritis Pain Contains No Aspirin
68016-183-05	2020-09-27	Arthitis Pain Acetaminophen Extended-release Tablets USP, 650 mg Pain Reliever / Fever Reducer For Temporary Relef of Minor Arthritis Pain Contains No Aspirin
68016-183-10	2020-09-27	Arthitis Pain Acetaminophen Extended-release Tablets USP, 650 mg Pain Reliever / Fever Reducer For Temporary Relef of Minor Arthritis Pain Contains No Aspirin
68016-183-05	2020-09-25	Arthitis Pain Acetaminophen Extended-release Tablets USP, 650 mg Pain Reliever / Fever Reducer For Temporary Relef of Minor Arthritis Pain Contains No Aspirin
68016-183-10	2020-09-25	Arthitis Pain Acetaminophen Extended-release Tablets USP, 650 mg Pain Reliever / Fever Reducer For Temporary Relef of Minor Arthritis Pain Contains No Aspirin
68016-183-05	2020-07-22	Arthitis Pain Acetaminophen Extended-release Tablets USP, 650 mg Pain Reliever / Fever Reducer For Temporary Relef of Minor Arthritis Pain Contains No Aspirin
68016-183-10	2020-07-22	Arthitis Pain Acetaminophen Extended-release Tablets USP, 650 mg Pain Reliever / Fever Reducer For Temporary Relef of Minor Arthritis Pain Contains No Aspirin

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68016-183-05	Acetaminophen	50 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	50		2
68016-183-10	Acetaminophen	100 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	100		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68016-183	ACETAMINOPHEN TABLET, FILM COATED, EXTENDED RELEASE [PHARMACY VALUE ALLIANCE, LLC]	2	Legacy NDC, 2 package rows	20201231_8fb0762d-da96-7b54-e053-2995a90a03fe.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 3 · 58 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
8HR Arthritis Pain	ACETAMINOPHEN	HARRIS TEETER	bfee9b3e-0c50-7c10-e053-2995a90af2fe	2026-08-05	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
8 HR Arthritis Pain	ACETAMINOPHEN	Dr. Reddy's Laboratories Inc.	8e780c23-997c-b960-226e-954037baad4b	2026-07-01	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
ACETAMINOPHEN	ACETAMINOPHEN	Granules India Limited	00eb3e4b-1507-4c9a-83a5-ef50cb312753	2026-06-15	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
Arthritis Pain	ACETAMINOPHEN	Grocery Outlet, Inc.	441d0aa0-9a65-98e9-e063-6294a90a5eb2	2026-05-21	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
ACETAMINOPHEN	ACETAMINOPHEN	NCS HealthCare of KY, LLC dba Vangard Labs	a3217b48-7482-4cc7-8811-ae75fd9d7805	2026-02-26	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
Acetaminophen	ACETAMINOPHEN	CVS PHARMACY INC	bd8ce39f-ccf8-3976-e053-2a95a90abb1f	2025-12-23	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
Acetaminophen	ACETAMINOPHEN	Granules USA, Inc.	96131c7b-bdff-0642-e053-2a95a90a4f32	2025-12-22	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
Acetaminophen	ACETAMINOPHEN	WAL-MART STORES INC	940936ac-e59f-7489-e053-2a95a90a6364	2025-12-19	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
Acetaminophen	ACETAMINOPHEN	WAL-MART STORES INC	e34d07b5-ccbb-cd14-e053-2a95a90a394b	2025-12-19	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
Acetaminophen	ACETAMINOPHEN	MEIJER DISTRIBUTION INC	ed23c587-7806-1f64-e053-2a95a90aea7f	2025-12-19	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
Acetaminophen	ACETAMINOPHEN	MEIJER, INC.	ed25620f-e39b-e30c-e053-2995a90af621	2025-12-19	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
Acetaminophen	ACETAMINOPHEN	RETAIL BUSINESS SERVICES,LLC.	a0fb0afe-9c25-d0f6-e053-2995a90adbba	2025-12-19	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
Acetaminophen	ACETAMINOPHEN	RETAIL BUSINESS SERVICES,LLC.	a56791ec-0037-51a3-e053-2995a90af761	2025-12-19	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
Acetaminophen	ACETAMINOPHEN	WALGREENS	8f8d43d1-8e73-483e-e053-2a95a90ac99b	2025-12-19	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
Acetaminophen	ACETAMINOPHEN	WALGREENS CO.	8dba6ae0-1bfb-84de-e053-2a95a90aae46	2025-12-19	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
Acetaminophen	ACETAMINOPHEN	LEADER/ Cardinal Health 110, Inc	f797848e-f23f-997b-e053-6394a90aae55	2025-12-19	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
Acetaminophen	ACETAMINOPHEN	MAJOR PHARMACEUTICALS	efd0a432-abbb-1f88-e053-2995a90a8ce5	2025-12-19	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
Acetaminophen	ACETAMINOPHEN	LEADER/ Cardinal Health 110, Inc	f5dc335d-d3cf-ba94-e053-2a95a90ac6d3	2025-12-19	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
Acetaminophen	ACETAMINOPHEN	SAM'S WEST INC	e77c2bc7-0258-4a6d-e053-2a95a90afe6e	2025-12-19	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
Acetaminophen	ACETAMINOPHEN	CVS PHARMACY iNC	90cea23f-5ddb-7a36-e053-2a95a90a20cf	2025-12-19	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544

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	8fb0762d-da96-7b54-e053-2995a90a03fe	2
1148399	8 HR acetaminophen 650 MG Extended Release Oral Tablet	SCD	8fb0762d-da96-7b54-e053-2995a90a03fe	2
1148399	8 HR APAP 650 MG Extended Release Oral Tablet	SY	8fb0762d-da96-7b54-e053-2995a90a03fe	2
1148399	acetaminophen 650 MG 8 HR Extended Release Oral Tablet	SY	8fb0762d-da96-7b54-e053-2995a90a03fe	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68016-183-10	68016018310	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68016-183-10)	2019-11-15	0000-00-00	No	No	Current