Home NDC 67296-1772 Acetaminophen and Codeine
Product NDC 67296-1772
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 · 8 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 67296-1772 I Inactivated by FDA excluded / ndc_excluded.zip 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 67296-1772 67296-1772-6 I Inactivated by FDA excluded / ndc_excluded.zip 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 67296-1772 I Inactivated by FDA excluded / ndc_excluded.zip 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 67296-1772 67296-1772-6 I Inactivated by FDA excluded / ndc_excluded.zip 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 67296-1772 I Inactivated by FDA excluded / ndc_excluded.zip 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 67296-1772 67296-1772-6 I Inactivated by FDA excluded / ndc_excluded.zip 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 67296-1772 I Inactivated by FDA excluded / ndc_excluded.zip 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 67296-1772 67296-1772-6 I Inactivated by FDA excluded / ndc_excluded.zip 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 RLD / RS 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.
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 (product): 67296-1772 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
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.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength 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
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 67296-1772-1 67296177201 10 TABLET in 1 BOTTLE (67296-1772-1) 10 tablet 2020-01-01 No No Current 67296-1772-5 67296177205 15 TABLET in 1 BOTTLE, PLASTIC (67296-1772-5) 15 tablet 2020-01-01 No No Current 67296-1772-6 67296177206 6 TABLET in 1 BOTTLE (67296-1772-6) 6 tablet 2020-01-01 0000-00-00 No No Current