ACETAMINOPHEN AND CODEINE

Product NDC: 61919-905
Requested package NDC: 61919-905-60
11-digit product format: 619190905
Labeler code: 61919
Product ID: 61919-905_f2161f2e-26ca-b0f8-e053-2995a90ac5b9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ACETAMINOPHEN AND CODEINE
Dosage form: TABLET
Route: ORAL
Labeler: Direct_Rx
Application: ANDA202800
Marketing category: ANDA
Marketing start: 2019-07-03
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: 2024-12-31
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	61919-905	61919-905-60	I	Inactivated by FDA		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 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
41b814f3-0166-1c53-c9ef-a0794c7daf9d	Product name	3	20221110
a590be26-846c-8659-a5a1-fb25907965dc	Product name	2	20221110
09d8330d-4fec-be98-3a66-f985140646b2	Product name	2	20210513
20c8cafe-5cfc-44f8-a9be-a664f437f780	Product name	2	20200225
182f9ab4-4ab5-c449-200f-87ce2ce8e550	Product name	2	20151105
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
c6fba691-a132-4ede-95c6-f8c6bd696636	Product name	1	20150902
c0200ab5-4954-454e-9676-30b741b245bd	Product name	1	20150730
e9576821-a971-5261-628e-82ad9e10acdb	Product name	2	20150121
2a21311a-89e2-0e83-2ebd-117f9798b2b2	Product name	1	20140508
30c51294-7ae9-8007-7de6-58222684a0be	Product name	1	20140508
47fd879b-91c5-e1e5-130f-29d082a871ec	Product name	1	20140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00	Product name	1	20140508
ce055423-1d7f-3c41-dff1-83660fa8cd96	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61919-905-60	2025-01-30	C162847	48780-1	2cef2736-99bb-d83d-e063-dadaa90ab31f	ACETAMINOPHEN AND CODEINE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61919-905-60	ACETAMINOPHEN AND CODEINE	60 in 1 BOTTLE	TABLET	60		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-905-60	EA - Each	61919-905	160536c2-ce59-4498-b25d-ce534169276d	1	2019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-905	ACETAMINOPHEN AND CODEINE TABLET [DIRECT_RX]	2	Legacy NDC, 1 package rows	20230113_8ccc18a8-d663-92ab-e053-2a95a90a4d33.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 · 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
993890	codeine phosphate 60 MG / acetaminophen 300 MG Oral Tablet	PSN	8ccc18a8-d663-92ab-e053-2a95a90a4d33	2
993890	acetaminophen 300 MG / codeine phosphate 60 MG Oral Tablet	SCD	8ccc18a8-d663-92ab-e053-2a95a90a4d33	2
993890	APAP 300 MG / codeine phosphate 60 MG Oral Tablet	SY	8ccc18a8-d663-92ab-e053-2a95a90a4d33	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-905-60	61919090560	60 TABLET in 1 BOTTLE (61919-905-60)	60 tablet	2019-07-03	0000-00-00	No	No	Current