Acetaminophen and Codeine Phosphate

Product NDC: 67046-903
11-digit product format: 670460903
Labeler code: 67046
Product ID: 67046-903_5a45c22c-dd1d-5bd3-e053-2991aa0aaf92
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Acetaminophen and Codeine Phosphate
Dosage form: TABLET
Route: ORAL
Labeler: Contract Pharmacy Services-PA
Application: ANDA088628
Marketing category: ANDA
Marketing start: 2017-09-28
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: 2020-12-31
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 · 9 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	67046-903		I	Inactivated by FDA	2026-10-05
excluded package	package	67046-903	67046-903-07	I	Inactivated by FDA	2026-10-05
excluded package	package	67046-903	67046-903-14	I	Inactivated by FDA	2026-10-05
excluded package	package	67046-903	67046-903-15	I	Inactivated by FDA	2026-10-05
excluded package	package	67046-903	67046-903-20	I	Inactivated by FDA	2026-10-05
excluded package	package	67046-903	67046-903-21	I	Inactivated by FDA	2026-10-05
excluded package	package	67046-903	67046-903-28	I	Inactivated by FDA	2026-10-05
excluded package	package	67046-903	67046-903-30	I	Inactivated by FDA	2026-10-05
excluded package	package	67046-903	67046-903-60	I	Inactivated by FDA	2026-10-05

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 3 · 162 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	67046-903-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67046-903-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67046-903-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67046-903-21	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67046-903-28	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67046-903-14	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67046-903-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67046-903-07	`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	67046-903-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67046-903-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67046-903-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67046-903-21	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67046-903-28	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67046-903-14	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67046-903-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67046-903-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67046-903-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67046-903-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67046-903-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67046-903-21	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67046-903-28	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67046-903-14	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67046-903-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67046-903-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67046-903-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67046-903-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67046-903-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67046-903-21	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67046-903-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67046-903-14	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67046-903-15	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67046-903-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67046-903-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67046-903-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67046-903-20	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67046-903-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67046-903-28	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67046-903-14	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67046-903-15	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67046-903-07	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67046-903-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67046-903-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67046-903-20	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67046-903-21	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67046-903-28	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67046-903-14	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67046-903-15	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67046-903-07	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67046-903-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67046-903-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67046-903-20	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67046-903-21	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67046-903-28	`302b2466d912…`	`e7b80fea0513…`

Source provenance: Browse the complete Orange Book source catalog.

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A088628-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	1985-03-06	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088628-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	1985-03-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088628-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	1985-03-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088628-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	1985-03-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088628-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	1985-03-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088628-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	1985-03-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088628-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	1985-03-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088628-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	1985-03-06	`ea99ee380514…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A088628-001	AA	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088628-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088628-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088628-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088628-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088628-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088628-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088628-001	AA	1	`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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, Related label table
NDC	Related label
67046-903-07	903 Acetaminophen/Codeine 300/30 mg Acetaminophen and Codeine Phosphate Tablets, USP CIII Rx only
67046-903-14	903 Acetaminophen/Codeine 300/30 mg Acetaminophen and Codeine Phosphate Tablets, USP CIII Rx only
67046-903-15	903 Acetaminophen/Codeine 300/30 mg Acetaminophen and Codeine Phosphate Tablets, USP CIII Rx only
67046-903-20	903 Acetaminophen/Codeine 300/30 mg Acetaminophen and Codeine Phosphate Tablets, USP CIII Rx only
67046-903-21	903 Acetaminophen/Codeine 300/30 mg Acetaminophen and Codeine Phosphate Tablets, USP CIII Rx only
67046-903-28	903 Acetaminophen/Codeine 300/30 mg Acetaminophen and Codeine Phosphate Tablets, USP CIII Rx only
67046-903-30	903 Acetaminophen/Codeine 300/30 mg Acetaminophen and Codeine Phosphate Tablets, USP CIII Rx only
67046-903-60	903 Acetaminophen/Codeine 300/30 mg Acetaminophen and Codeine Phosphate Tablets, USP CIII Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
67046-903-07	Acetaminophen and Codeine Phosphate	7 in 1 BLISTER PACK	TABLET	7	1
67046-903-14	Acetaminophen and Codeine Phosphate	14 in 1 BLISTER PACK	TABLET	14	1
67046-903-15	Acetaminophen and Codeine Phosphate	15 in 1 BLISTER PACK	TABLET	15	1
67046-903-20	Acetaminophen and Codeine Phosphate	20 in 1 BLISTER PACK	TABLET	20	1
67046-903-21	Acetaminophen and Codeine Phosphate	21 in 1 BLISTER PACK	TABLET	21	1
67046-903-28	Acetaminophen and Codeine Phosphate	28 in 1 BLISTER PACK	TABLET	28	1
67046-903-30	Acetaminophen and Codeine Phosphate	30 in 1 BLISTER PACK	TABLET	30	1
67046-903-60	Acetaminophen and Codeine Phosphate	60 in 1 BLISTER PACK	TABLET	60	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67046-903	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [CONTRACT PHARMACY SERVICES-PA]	1	Legacy NDC, 8 package rows	20170929_5a45c22c-dd1c-5bd3-e053-2991aa0aaf92.zip

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
993781	codeine phosphate 30 MG / acetaminophen 300 MG Oral Tablet	PSN	5a45c22c-dd1c-5bd3-e053-2991aa0aaf92	1
993781	acetaminophen 300 MG / codeine phosphate 30 MG Oral Tablet	SCD	5a45c22c-dd1c-5bd3-e053-2991aa0aaf92	1
993781	APAP 300 MG / codeine phosphate 30 MG Oral Tablet	SY	5a45c22c-dd1c-5bd3-e053-2991aa0aaf92	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67046-903-07	67046090307	7 TABLET in 1 BLISTER PACK (67046-903-07)	7 tablet	2017-09-28	0000-00-00	No	No	Current
67046-903-14	67046090314	14 TABLET in 1 BLISTER PACK (67046-903-14)	14 tablet	2017-09-28	0000-00-00	No	No	Current
67046-903-15	67046090315	15 TABLET in 1 BLISTER PACK (67046-903-15)	15 tablet	2017-09-28	0000-00-00	No	No	Current
67046-903-20	67046090320	20 TABLET in 1 BLISTER PACK (67046-903-20)	20 tablet	2017-09-28	0000-00-00	No	No	Current
67046-903-21	67046090321	21 TABLET in 1 BLISTER PACK (67046-903-21)	21 tablet	2017-09-28	0000-00-00	No	No	Current
67046-903-28	67046090328	28 TABLET in 1 BLISTER PACK (67046-903-28)	28 tablet	2017-09-28	0000-00-00	No	No	Current
67046-903-30	67046090330	30 TABLET in 1 BLISTER PACK (67046-903-30)	30 tablet	2017-09-28	0000-00-00	No	No	Current
67046-903-60	67046090360	60 TABLET in 1 BLISTER PACK (67046-903-60)	60 tablet	2017-09-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
903 Acetaminophen/Codeine 300/30 mg Acetaminophen and Codeine Phosphate Tablets, USP CIII Rx only	Contract Pharmacy Services-PA \| Coupler Enterprises Inc.	2017-09-28	HUMAN PRESCRIPTION DRUG LABEL	1