ACETAMINOPHEN AND CODEINE PHOSPHATE

Product NDC: 50090-5200
11-digit product format: 500905200
Labeler code: 50090
Product ID: 50090-5200_7184747e-5196-4125-a306-f3afb17a052f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: acetaminophen and codeine phosphate
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA211610
Marketing category: ANDA
Marketing start: 2019-08-02
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: 2023-12-31
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 · 7 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	50090-5200		D	Discontinued by firm	2026-09-09
excluded package	package	50090-5200	50090-5200-0	D	Discontinued by firm	2026-09-09
excluded package	package	50090-5200	50090-5200-1	D	Discontinued by firm	2026-09-09
excluded package	package	50090-5200	50090-5200-2	D	Discontinued by firm	2026-09-09
excluded package	package	50090-5200	50090-5200-3	D	Discontinued by firm	2026-09-09
excluded package	package	50090-5200	50090-5200-4	D	Discontinued by firm	2026-09-09
excluded package	package	50090-5200	50090-5200-7	D	Discontinued by firm	2026-09-09

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 · 14 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-5200-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-5200-7	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-5200-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-5200-4	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-5200-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-5200-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-5200-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-5200-7	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-5200-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-5200-4	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-5200-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-5200-2	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A211610-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN; CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	2019-06-27
A211610-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN; CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2019-06-27
A211610-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN; CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA	2019-06-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211610-001	AA
A211610-002	AA
A211610-003	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 · 126 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
2026-08-18 06:07:40	2026-07	A211610-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	2019-06-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211610-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2019-06-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211610-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA	2019-06-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211610-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	2019-06-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211610-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2019-06-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211610-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA	2019-06-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211610-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	2019-06-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211610-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2019-06-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211610-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA	2019-06-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211610-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	2019-06-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211610-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2019-06-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211610-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA	2019-06-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211610-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	2019-06-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211610-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2019-06-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211610-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA	2019-06-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211610-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	2019-06-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211610-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2019-06-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211610-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA	2019-06-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211610-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	2019-06-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211610-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2019-06-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211610-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA	2019-06-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211610-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	2019-06-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211610-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2019-06-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211610-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA	2019-06-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211610-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	2019-06-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211610-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2019-06-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211610-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA	2019-06-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211610-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	2019-06-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211610-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2019-06-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211610-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA	2019-06-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211610-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	2019-06-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211610-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2019-06-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211610-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA	2019-06-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211610-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	2019-06-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211610-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2019-06-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211610-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA	2019-06-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211610-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	2019-06-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211610-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2019-06-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211610-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA	2019-06-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211610-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	2019-06-27	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A211610-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211610-002	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211610-003	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211610-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211610-002	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211610-003	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211610-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211610-002	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211610-003	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211610-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211610-002	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211610-003	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211610-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211610-002	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211610-003	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211610-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211610-002	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211610-003	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211610-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211610-002	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211610-003	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211610-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211610-002	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211610-003	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211610-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211610-002	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211610-003	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211610-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211610-002	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211610-003	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211610-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211610-002	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211610-003	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211610-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211610-002	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211610-003	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211610-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211610-002	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211610-003	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211610-001	AA	1	`1e350fbaab3a…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-5200-0	EA - Each	50090-5200	07ffe590-9030-4a79-8662-01a969f16aeb	1	2022-12-07
50090-5200-1	EA - Each	50090-5200	5d1a285a-99c1-4d04-955b-385676167203	1	2022-12-07
50090-5200-2	EA - Each	50090-5200	99179ba8-9e54-43e6-ba83-fabf24938194	1	2022-12-07
50090-5200-3	EA - Each	50090-5200	ec613156-9720-4336-a220-648f3f727591	1	2022-12-07
50090-5200-4	EA - Each	50090-5200	78ccdffd-8b8f-43b5-9af4-af47b0863abc	1	2022-12-07
50090-5200-7	EA - Each	50090-5200	87287a90-2626-4f32-bb33-fa041f960e8f	1	2022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-5200	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [A-S MEDICATION SOLUTIONS]	7	Legacy NDC	20231217_f0d519e9-2079-4a25-b305-498061c4df0f.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 1 · 13 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	REMEDYREPACK INC.	4c966d73-77c6-4514-954e-57aa06a080c6	2026-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211610 application number: ANDA211610
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN AND CODEINE PHOSPHATE	REMEDYREPACK INC.	1fe39679-fd58-4d2c-ba61-49d492a2b087	2026-07-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211610 application number: ANDA211610
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN AND CODEINE PHOSPHATE	Redpharm Drug	52617668-acc3-65cd-e063-6294a90ab919	2026-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211610 application number: ANDA211610
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN AND CODEINE PHOSPHATE	Bryant Ranch Prepack	ff77a959-c77a-4911-8f7c-e2a3e24a6305	2026-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211610 application number: ANDA211610
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN AND CODEINE PHOSPHATE	Bryant Ranch Prepack	f308fd07-f004-42de-963d-426b268bba93	2026-05-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211610 application number: ANDA211610
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN AND CODEINE PHOSPHATE	Bryant Ranch Prepack	e73b17c4-9f24-4b32-8920-61c58c40a714	2026-03-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211610 application number: ANDA211610
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN AND CODEINE PHOSPHATE	Bryant Ranch Prepack	879db1b5-6365-4151-9879-80d8a2a3cd8a	2026-03-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211610 application number: ANDA211610
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN AND CODEINE PHOSPHATE	Eywa Pharma Inc	79377617-686b-4640-b2b8-e1358cf82358	2026-03-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211610 application number: ANDA211610
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN AND CODEINE PHOSPHATE	Asclemed USA, Inc.	682ef287-647a-4d89-9bbf-75907ebd10f2	2025-08-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211610 application number: ANDA211610
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN AND CODEINE PHOSPHATE	Preferred Pharmaceuticals Inc.	7ab27392-9c6e-4ec3-85e7-06b43fcab3b1	2025-06-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211610 application number: ANDA211610
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN AND CODEINE PHOSPHATE	NuCare Pharmaceuticals, Inc.	1e932a34-a7d3-e4ec-e063-6294a90a25b1	2025-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211610 application number: ANDA211610
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN AND CODEINE PHOSPHATE	NuCare Pharmaceuticals, Inc.	1e01f923-38c1-9b59-e063-6394a90a22f1	2024-07-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211610 application number: ANDA211610
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN AND CODEINE PHOSPHATE	Bryant Ranch Prepack	ebdbc975-4e0e-4b83-8cf4-f29da829113a	2024-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211610 application number: ANDA211610

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
50090-5200-0	50090520000	10 TABLET in 1 BOTTLE (50090-5200-0)	10 tablet	2020-10-02	0000-00-00	No	No	Current
50090-5200-1	50090520001	12 TABLET in 1 BOTTLE (50090-5200-1)	12 tablet	2020-10-02	0000-00-00	No	No	Current
50090-5200-2	50090520002	15 TABLET in 1 BOTTLE (50090-5200-2)	15 tablet	2020-10-02	0000-00-00	No	No	Current
50090-5200-3	50090520003	20 TABLET in 1 BOTTLE (50090-5200-3)	20 tablet	2020-10-02	0000-00-00	No	No	Current
50090-5200-4	50090520004	30 TABLET in 1 BOTTLE (50090-5200-4)	30 tablet	2020-10-02	0000-00-00	No	No	Current
50090-5200-7	50090520007	100 TABLET in 1 BOTTLE (50090-5200-7)	100 tablet	2020-10-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ACETAMINOPHEN AND CODEINE PHOSPHATE - A-S Medication Solutions	A-S Medication Solutions	2023-12-15	Human Prescription Drug Label	7