Acetaminophen and Codeine Phosphate

Product NDC: 50090-1934
Requested package NDC: 50090-1934-0
11-digit product format: 500901934
Labeler code: 50090
Product ID: 50090-1934_cb34aa1a-345c-427b-8e8f-22f3d519e621
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Acetaminophen and Codeine Phosphate
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA202800
Marketing category: ANDA
Marketing start: 2013-04-15
Marketing end: 0000-00-00
Substance: ACETAMINOPHEN; CODEINE PHOSPHATE
Active strength: 300 mg/1; mg/1
Pharmacologic classes: Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule: CIII
NDC exclude flag: No
Listing certified through: 2022-12-31
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	50090-1934	50090-1934-0	D	Discontinued by firm		2026-08-03

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 · 11 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…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A202800-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN; CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	2013-04-15
A202800-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN; CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2013-04-15
A202800-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN; CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA	2013-04-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A202800-001	AA
A202800-002	AA
A202800-003	AA

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 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A202800-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	2013-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202800-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2013-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202800-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA	2013-04-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202800-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	2013-04-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202800-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2013-04-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202800-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA	2013-04-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202800-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	2013-04-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202800-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2013-04-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202800-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA	2013-04-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202800-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	2013-04-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202800-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2013-04-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202800-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA	2013-04-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202800-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	2013-04-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202800-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2013-04-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202800-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA	2013-04-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202800-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	2013-04-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202800-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2013-04-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202800-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA	2013-04-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202800-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	2013-04-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202800-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2013-04-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202800-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA	2013-04-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202800-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	2013-04-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202800-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2013-04-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202800-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA	2013-04-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202800-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	2013-04-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202800-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2013-04-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202800-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA	2013-04-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202800-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	2013-04-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202800-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2013-04-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202800-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA	2013-04-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202800-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	2013-04-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202800-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2013-04-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202800-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA	2013-04-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202800-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	2013-04-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202800-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2013-04-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202800-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA	2013-04-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202800-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	2013-04-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202800-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2013-04-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202800-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA	2013-04-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202800-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	2013-04-15	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A202800-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202800-002	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202800-003	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202800-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202800-002	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202800-003	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202800-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202800-002	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202800-003	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202800-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202800-002	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202800-003	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202800-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202800-002	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202800-003	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202800-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202800-002	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202800-003	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202800-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202800-002	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202800-003	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202800-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202800-002	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202800-003	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202800-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202800-002	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202800-003	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202800-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202800-002	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202800-003	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202800-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202800-002	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202800-003	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202800-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202800-002	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202800-003	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202800-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202800-002	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202800-003	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202800-001	AA	1	`8072bd15b7f6…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
50090-1934-0	2023-02-06	Acetaminophen and Codeine Phosphate Tablets, USP CIII
50090-1934-1	2023-02-06	Acetaminophen and Codeine Phosphate Tablets, USP CIII
50090-1934-6	2023-02-06	Acetaminophen and Codeine Phosphate Tablets, USP CIII
50090-1934-0	2023-01-30	Acetaminophen and Codeine Phosphate Tablets, USP CIII
50090-1934-1	2023-01-30	Acetaminophen and Codeine Phosphate Tablets, USP CIII
50090-1934-6	2023-01-30	Acetaminophen and Codeine Phosphate Tablets, USP CIII

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-1934-1	EA - Each	50090-1934	2eba874d-0c67-4519-9337-8140bd9c6d5b	1	2018-11-06

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 · 7 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	Aurolife Pharma, LLC	02386806-02d4-47e3-9c8b-7810146ee795	2025-12-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202800 application number: ANDA202800
Acetaminophen and Codeine Phosphate	ACETAMINOPHEN AND CODEINE PHOSPHATE	Bryant Ranch Prepack	30da1bea-2dbc-4086-a5cf-8ed471bb6593	2024-08-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202800 application number: ANDA202800
Acetaminophen and Codeine Phosphate	ACETAMINOPHEN AND CODEINE PHOSPHATE	Bryant Ranch Prepack	9f2127d9-d60b-42d3-9b6c-798e63dd68d1	2024-08-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202800 application number: ANDA202800
Acetaminophen and Codeine Phosphate	ACETAMINOPHEN AND CODEINE PHOSPHATE	NuCare Pharmaceuticals,Inc.	8f12016d-904f-00b4-e053-2a95a90ad02a	2024-06-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202800 application number: ANDA202800
Acetaminophen and Codeine Phosphate	ACETAMINOPHEN AND CODEINE PHOSPHATE	NuCare Pharmaceuticals,Inc.	80c9a58d-98ae-5497-e053-2991aa0a61fb	2024-06-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202800 application number: ANDA202800
Acetaminophen and Codeine Phosphate	ACETAMINOPHEN AND CODEINE PHOSPHATE	NuCare Pharmaceuticals,Inc.	7d69403e-90d0-7a80-e053-2a91aa0a5552	2024-06-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202800 application number: ANDA202800
Acetaminophen and Codeine Phosphate	ACETAMINOPHEN AND CODEINE PHOSPHATE	Proficient Rx LP	75b50751-5237-4e3e-b7ee-1605c0602f3b	2022-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202800 application number: ANDA202800

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
GSL05Y1MN6	CODEINE PHOSPHATE	41444-62-6	CODEINE PHOSPHATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-1934-0	50090193400	40 TABLET in 1 BOTTLE (50090-1934-0)	40 tablet	2015-07-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Acetaminophen and Codeine Phosphate Tablets, USP CIII	A-S Medication Solutions	2023-02-04	Human Prescription Drug Label	11