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 18 of 50 · 998 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acetaminophen	ACETAMINOPHEN	RITE AID	d20b4682-fed2-3ea2-e053-2995a90aa47e	2025-12-19	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	FAMILY DOLLAR	f824602a-8e7b-b8c3-e053-6294a90a6d9d	2025-12-19	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	FAMILY DOLLAR	f8383108-0970-9f1e-e053-6294a90ad38f	2025-12-19	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	RITE AID	d20a7f7a-febf-54f9-e053-2a95a90a06b1	2025-12-19	Warnings	Name fallback generic name: ACETAMINOPHEN
ACETAMINOPHEN 500 MG	ACETAMINOPHEN	NUVICARE LLC	591ee107-e953-4982-b75f-13a0afd7c4ae	2025-12-19	Warnings	Name fallback generic name: ACETAMINOPHEN
ACETAMINOPHEN 500 MG	ACETAMINOPHEN	NUVICARE LLC	95edf7bd-b6a7-4be5-9ad7-8748e7c2d06e	2025-12-19	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	BETTER LIVING BRANDS LLC.	ac0e96d0-746e-fb42-e053-2a95a90a1957	2025-12-18	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	BETTER LIVING BRANDS LLC.	ac0e5dc0-96eb-47b2-e053-2995a90add0e	2025-12-18	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	Caplin Steriles Limited	b6f83919-8608-4648-9ac6-e13eadac8404	2025-12-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ACETAMINOPHEN
Pain and Fever Childrens	ACETAMINOPHEN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	e55645ab-66f9-4160-8247-395bc5b02711	2025-12-18	Warnings	Name fallback generic name: ACETAMINOPHEN
CareOne Childrens Acetaminophen	ACETAMINOPHEN	American Sales Company	07bc6632-fabb-427d-81f3-c27c54caa6a0	2025-12-17	Warnings	Name fallback generic name: ACETAMINOPHEN
MAXIMUM STRENGTH NON-ASPIRIN 100	ACETAMINOPHEN	JHK Inc dba American Safety & First Aid	1d3e9948-883e-4668-9bb8-d699a283b51a	2025-12-16	Warnings	Name fallback generic name: ACETAMINOPHEN
TYLENOL EXTRA STRENGTH, TRAVEL BASIX	ACETAMINOPHEN	Lil' Drug Store Products, Inc.	fa951d50-b79c-4161-8c81-fcf386b0964e	2025-12-15	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Reliever	ACETAMINOPHEN	WALGREENS	40a1b354-9b2e-1cf3-e063-6394a90af113	2025-12-13	Warnings	Name fallback generic name: ACETAMINOPHEN
topcare childrens pain and fever	ACETAMINOPHEN	Topco Associates LLC	911492d5-e065-4b8f-b2dc-cb6a6678d0ae	2025-12-13	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	PAI Holdings, LLC dba PAI Pharma	33599f18-5f49-4f22-8a77-a072115763ef	2025-12-11	Warnings	Name fallback generic name: ACETAMINOPHEN
Extra Strength Pain Relief	ACETAMINOPHEN	VALU MERCHANDISERS COMPANY	005e299e-aa84-49d9-bbca-12236f865a27	2025-12-11	Warnings	Name fallback generic name: ACETAMINOPHEN
Extra Strength Pain Relief	ACETAMINOPHEN	VALU MERCHANDISERS COMPANY	d4c32e70-778a-4d66-b9d0-03944a528421	2025-12-11	Warnings	Name fallback generic name: ACETAMINOPHEN
8 Hour Arthritis Pain	ACETAMINOPHEN	VALU MERCHANDISERS COMPANY	cd3a7094-ddb5-4583-a1bc-dc6ce280418c	2025-12-11	Warnings	Name fallback generic name: ACETAMINOPHEN
Extra Strength Pain Relief	ACETAMINOPHEN	VALU MERCHANDISERS COMPANY	5a80cb17-7731-4457-acd3-64cf4accf862	2025-12-11	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