Application 087508

Type: ANDA
Sponsor: PHARM ASSOC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN; CODEINE PHOSPHATE	SOLUTION;ORAL	120MG/5ML;12MG/5ML	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN; CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL		RS, Approved before 1982

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL		RS, Approved before 1982	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087508-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087508-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087508-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087508-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087508-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A087508-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087508-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087508-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087508-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A087508-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087508-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A087508-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A087508-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A087508-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A087508-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A087508-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A087508-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A087508-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A087508-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A087508-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A087508-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A087508-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A087508-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A087508-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A087508-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A087508-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A087508-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A087508-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A087508-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A087508-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A087508-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A087508-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A087508-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A087508-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A087508-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A087508-001	AA	1	`cb3db0bc1861…`

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 and Codeine Phosphate	ACETAMINOPHEN AND CODEINE PHOSPHATE	PAI Holdings, LLC dba PAI Pharma	95ac6875-6b14-4cde-8efb-80704e39b8d8	2026-08-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087508 application number: ANDA087508 ndc (product): 0121-0504
Acetaminophen and Codeine Phosphate	ACETAMINOPHEN AND CODEINE PHOSPHATE	Genus Lifesciences Inc.	95a5d638-3072-4c37-a4cd-f8550328e2c6	2026-02-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087508 application number: ANDA087508

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 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0121-0504	Acetaminophen and Codeine Phosphate	ACETAMINOPHEN and CODEINE PHOSPHATE	Pharmaceutical Associates, Inc.	ANDA	Current
21695-547	Acetaminophen and Codeine Phosphate	Acetaminophen and Codeine Phosphate	Rebel Distributors Corp.	ANDA	Current
33261-470	Acetaminophen and Codeine Phosphate	ACETAMINOPHEN and CODEINE PHOSPHATE	Aidarex Pharmaceuticals LLC	ANDA	Current
50090-0215	Acetaminophen and Codeine Phosphate	ACETAMINOPHEN and CODEINE PHOSPHATE	A-S Medication Solutions	ANDA	Current
50090-0215	Acetaminophen and Codeine Phosphate	ACETAMINOPHEN and CODEINE PHOSPHATE	A-S Medication Solutions	ANDA	Current
50090-0215	Acetaminophen and Codeine Phosphate	ACETAMINOPHEN and CODEINE PHOSPHATE	A-S Medication Solutions	ANDA	Current
53002-3410	Acetaminophen and Codeine Phosphate	ACETAMINOPHEN and CODEINE PHOSPHATE	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-3410	Acetaminophen and Codeine Phosphate	ACETAMINOPHEN and CODEINE PHOSPHATE	RPK Pharmaceuticals, Inc.	ANDA	Current
63187-291	Acetaminophen and Codeine Phosphate	ACETAMINOPHEN and CODEINE PHOSPHATE	Proficient Rx LP	ANDA	Current
63187-291	Acetaminophen and Codeine Phosphate	ACETAMINOPHEN and CODEINE PHOSPHATE	Proficient Rx LP	ANDA	Current
66267-997	Acetaminophen and Codeine Phosphate	ACETAMINOPHEN and CODEINE PHOSPHATE	NuCare Pharmaceuticals,Inc.	ANDA	Current
66267-997	Acetaminophen and Codeine Phosphate	ACETAMINOPHEN and CODEINE PHOSPHATE	NuCare Pharmaceuticals,Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76139	ORIG	2023-11-03