Application 072344

Type: ANDA
Sponsor: ACP NIMBLE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ACEPHEN	ACETAMINOPHEN	SUPPOSITORY;RECTAL	325MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A072344-001	ACEPHEN	ACETAMINOPHEN	325MG	SUPPOSITORY / RECTAL			1992-03-27

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`f41ea6bd6efb…`

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 19 of 50 · 998 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
8 Hour Pain Relief	ACETAMINOPHEN	VALU MERCHANDISERS COMPANY	d11a7412-a543-0e34-e053-2995a90afd63	2025-12-11	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	VALU MERCHANDISERS COMPANY	02e3798f-86d9-64b4-e063-6294a90a29de	2025-12-11	Warnings	Name fallback generic name: ACETAMINOPHEN
Regular Strength Pain Relief	ACETAMINOPHEN	VALU MERCHANDISERS COMPANY	f7e87eac-59fb-4a72-b5c6-02953112be6a	2025-12-11	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	PAI Holdings, LLC dba PAI Pharma	355a094c-bed9-4959-8cf0-619f0e246105	2025-12-11	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	PAI Holdings, LLC dba PAI Pharma	fac4e0c6-684f-45a1-99f2-de4de4017cc8	2025-12-11	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	CHAIN DRUG MARKETING ASSOCIATION INC	2e30754a-42f7-4da2-944c-be61cee47b43	2025-12-10	Warnings	Name fallback generic name: ACETAMINOPHEN
MAX relief junior	ACETAMINOPHEN	ATLANTIC BIOLOGICALS CORP.	ff1f6f82-0c7c-4e3f-a2bd-3185e16fa770	2025-12-10	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Relief	ACETAMINOPHEN	AAA Pharmaceutical, Inc.	36ad34f4-4e66-f371-e063-6394a90ae76a	2025-12-09	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Reliever	ACETAMINOPHEN	LIDL US LLC	ec543339-20ab-2cba-e053-2995a90ac740	2025-12-09	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Relief Extra Strength	ACETAMINOPHEN	CHAIN DRUG MARKETING ASSOCIATION, INC.	c57c10fc-f182-4153-8974-ef359a5f5ac1	2025-12-09	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Relief Rapid Release Gelcaps Extra Strength	ACETAMINOPHEN	Safeway	c830d1ac-c4c5-4eb1-98bb-22707cb6db91	2025-12-09	Warnings	Name fallback generic name: ACETAMINOPHEN
childrens acetaminophen	ACETAMINOPHEN	United Natural Foods, Inc. dba UNFI	f65203a2-64f0-4138-97e4-6eab99194178	2025-12-09	Warnings	Name fallback generic name: ACETAMINOPHEN
BERKLEY AND JENSEN RAPID RELEASE ACETAMINOPHEN	ACETAMINOPHEN	BJWC	e27b6637-ef32-44b5-a531-b6617d02fbbf	2025-12-08	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Reliever	ACETAMINOPHEN	WALGREENS	3f9f1740-9e8b-6a2d-e063-6294a90a67cb	2025-12-06	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen Easy Tabs Extra Strength	ACETAMINOPHEN	United Natural Foods, Inc. dba UNFI	729132cd-f209-447a-8949-a90b5a5c01da	2025-12-05	Warnings	Name fallback generic name: ACETAMINOPHEN
ACETAMINOPHEN	ACETAMINOPHEN	Granules Pharmaceuticals Inc.	d5352861-6926-f1b0-e053-2a95a90a7d66	2025-12-04	Warnings	Name fallback generic name: ACETAMINOPHEN
Extra Strength Acetaminophen	ACETAMINOPHEN	Geri-Care Pharmaceutical Corp	7a29dde6-a177-6206-e053-2991aa0a01f2	2025-12-04	Warnings	Name fallback generic name: ACETAMINOPHEN
Extra Strength Pain Relief	ACETAMINOPHEN	Geri-Care Pharmaceutical Corp	7570aaa2-3238-4cd3-b788-915caa970dba	2025-12-04	Warnings	Name fallback generic name: ACETAMINOPHEN
Midol Long Lasting Relief	ACETAMINOPHEN	Bayer HealthCare LLC.	4a3a711d-c882-3525-e054-00144ff8d46c	2025-12-04	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	Major Pharmaceuticals	e1a55e0d-bb86-4515-8436-51a74b403685	2025-12-02	Warnings	Name fallback generic name: ACETAMINOPHEN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0713-0164	ACEPHEN	Acetaminophen	Cosette Pharmaceuticals, Inc.	ANDA	Current
0713-0164	ACEPHEN	Acetaminophen	G&W Laboratories, Inc.	ANDA	Current
68788-8934	ACEPHEN	Acetaminophen	Preferred Pharmaceuticals Inc.	ANDA	Current
76413-302	ACEPHEN	Acetaminophen	Central Texas Community Health Centers	ANDA	Current