Acetaminophen and Codeine

Product NDC: 67296-1772
Requested package NDC: 67296-1772-6
11-digit product format: 672961772
Labeler code: 67296
Product ID: 67296-1772_3253a2e4-0bc4-4ce7-e063-6294a90a6c51
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Acetaminophen and Codeine
Dosage form: TABLET
Route: ORAL
Labeler: RedPharm Drug, Inc.
Application: ANDA040779
Marketing category: ANDA
Marketing start: 2020-01-01
Substance: ACETAMINOPHEN; CODEINE PHOSPHATE
Active strength: 300; 30 mg/1; mg/1
Pharmacologic classes: Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule: CIII
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 4 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
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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

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
A040779-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN; CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA		2008-05-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040779-001	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 2 · 41 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	A040779-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2008-05-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040779-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2008-05-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040779-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2008-05-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040779-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2008-05-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040779-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2008-05-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040779-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2008-05-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040779-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2008-05-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040779-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2008-05-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040779-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2008-05-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040779-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2008-05-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040779-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2008-05-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040779-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2008-05-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040779-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2008-05-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040779-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2008-05-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040779-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2008-05-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040779-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2008-05-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040779-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2008-05-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040779-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2008-05-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040779-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2008-05-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040779-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2008-05-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040779-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2008-05-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040779-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2008-05-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040779-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2008-05-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040779-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2008-05-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040779-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2008-05-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040779-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2008-05-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040779-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2008-05-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040779-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2008-05-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040779-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2008-05-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040779-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2008-05-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040779-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2008-05-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040779-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2008-05-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040779-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2008-05-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040779-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2008-05-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040779-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2008-05-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040779-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2008-05-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040779-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2008-05-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040779-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2008-05-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040779-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2008-05-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040779-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	2008-05-29	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A040779-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040779-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040779-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040779-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040779-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040779-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040779-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040779-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040779-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040779-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040779-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040779-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040779-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040779-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040779-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040779-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040779-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040779-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040779-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040779-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040779-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040779-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040779-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040779-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040779-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040779-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040779-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040779-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040779-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040779-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040779-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040779-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040779-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040779-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040779-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040779-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040779-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040779-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040779-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040779-001	AA	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Acetaminophen and Codeine
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	300 mg/1
CODEINE PHOSPHATE	30 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
362O9ITL9D	Internal UNII lookup
GSL05Y1MN6	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
993781	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
a35b4ba3-43c0-73c8-e053-2a95a90af5b5	Available on FDA.report

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
67296-1772-6	2024-07-25	C162847	48780-1	1030e365-4867-111a-e063-dadaa90a10e2	Acetaminophen and Codeine 300/30mg tabs
67296-1772-6	2024-01-30	C162847	48780-1	1030e365-4867-111a-e063-dadaa90a10e2	Acetaminophen and Codeine 300/30mg tabs

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
67296-1772-1	Acetaminophen and Codeine	10 in 1 BOTTLE	TABLET	10	5
67296-1772-5	Acetaminophen and Codeine	15 in 1 BOTTLE, PLASTIC	TABLET	15	5
67296-1772-6	Acetaminophen and Codeine	6 in 1 BOTTLE	TABLET	6	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67296-1772	ACETAMINOPHEN AND CODEINE TABLET [REDPHARM DRUG, INC.]	5	Current NDC, Legacy NDC, 3 package rows	20250410_a35b4ba3-43c0-73c8-e053-2a95a90af5b5.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acetaminophen and Codeine	ACETAMINOPHEN AND CODEINE	Bryant Ranch Prepack	7d940b9c-7406-4182-9052-c6a5806337a0	2026-05-06	Boxed warning, Warnings	Exact identifier application applno (ANDA): 040779 application number: ANDA040779
Acetaminophen and Codeine	ACETAMINOPHEN AND CODEINE	Amneal Pharmaceuticals LLC	8bc4108b-314e-4a52-a37c-631c6b869b04	2025-12-01	Boxed warning, Warnings	Exact identifier application applno (ANDA): 040779 application number: ANDA040779
Acetaminophen and Codeine	ACETAMINOPHEN AND CODEINE	RedPharm Drug, Inc.	a35b4ba3-43c0-73c8-e053-2a95a90af5b5	2025-04-09	Boxed warning, Warnings	Exact identifier application applno (ANDA): 040779 application number: ANDA040779 ndc (package): 67296-1772-6 ndc (product): 67296-1772 ndc11 (package): 67296177206
Acetaminophen and Codeine	ACETAMINOPHEN AND CODEINE	Proficient Rx LP	2472bb8a-88b7-4eec-8806-34adef0c9ab9	2021-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040779 application number: ANDA040779
Acetaminophen and Codeine	ACETAMINOPHEN AND CODEINE	Asclemed USA, Inc.	3f83ba75-9415-4ace-9416-04d666c005a2	2020-10-30	Boxed warning, Warnings	Exact identifier application applno (ANDA): 040779 application number: ANDA040779

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	a35b4ba3-43c0-73c8-e053-2a95a90af5b5	5
993781	acetaminophen 300 MG / codeine phosphate 30 MG Oral Tablet	SCD	a35b4ba3-43c0-73c8-e053-2a95a90af5b5	5
993781	APAP 300 MG / codeine phosphate 30 MG Oral Tablet	SY	a35b4ba3-43c0-73c8-e053-2a95a90af5b5	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67296-1772-6	67296177206	6 TABLET in 1 BOTTLE (67296-1772-6)	6 tablet	2020-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Acetaminophen and Codeine 300/30mg tabs	RedPharm Drug, Inc.	2025-04-09	HUMAN PRESCRIPTION DRUG LABEL	5