Home NDC 71335-0545 Acetaminophen and Codeine
Product NDC 71335-0545
11-digit product format 713350545
Labeler code 71335
Product ID 71335-0545_807a4459-2481-4325-a73e-a1e6bff4d5c0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Acetaminophen and Codeine
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA040779
Marketing category ANDA
Marketing start 2008-05-29
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 2027-12-31
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 3 · 143 matching rows.
View current auxiliary records. · View the auxiliary file history.
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.
Additional Listing Data#
Finished product Yes
Brand name base Acetaminophen and Codeine
Listing expiration 2027-12-31 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# NDC, Effective, Related label table NDC Effective Related label 71335-0545-0 2024-04-18 Acetaminophen and Codeine Phosphate Tablets, USP CIII 300 mg/30 mg Rx Only 71335-0545-1 2024-04-18 Acetaminophen and Codeine Phosphate Tablets, USP CIII 300 mg/30 mg Rx Only 71335-0545-2 2024-04-18 Acetaminophen and Codeine Phosphate Tablets, USP CIII 300 mg/30 mg Rx Only 71335-0545-3 2024-04-18 Acetaminophen and Codeine Phosphate Tablets, USP CIII 300 mg/30 mg Rx Only 71335-0545-4 2024-04-18 Acetaminophen and Codeine Phosphate Tablets, USP CIII 300 mg/30 mg Rx Only 71335-0545-5 2024-04-18 Acetaminophen and Codeine Phosphate Tablets, USP CIII 300 mg/30 mg Rx Only 71335-0545-6 2024-04-18 Acetaminophen and Codeine Phosphate Tablets, USP CIII 300 mg/30 mg Rx Only 71335-0545-7 2024-04-18 Acetaminophen and Codeine Phosphate Tablets, USP CIII 300 mg/30 mg Rx Only 71335-0545-8 2024-04-18 Acetaminophen and Codeine Phosphate Tablets, USP CIII 300 mg/30 mg Rx Only 71335-0545-9 2024-04-18 Acetaminophen and Codeine Phosphate Tablets, USP CIII 300 mg/30 mg Rx Only 71335-0545-0 2024-01-30 Acetaminophen and Codeine Phosphate Tablets, USP CIII 300 mg/30 mg Rx Only 71335-0545-1 2024-01-30 Acetaminophen and Codeine Phosphate Tablets, USP CIII 300 mg/30 mg Rx Only 71335-0545-2 2024-01-30 Acetaminophen and Codeine Phosphate Tablets, USP CIII 300 mg/30 mg Rx Only 71335-0545-3 2024-01-30 Acetaminophen and Codeine Phosphate Tablets, USP CIII 300 mg/30 mg Rx Only 71335-0545-4 2024-01-30 Acetaminophen and Codeine Phosphate Tablets, USP CIII 300 mg/30 mg Rx Only 71335-0545-5 2024-01-30 Acetaminophen and Codeine Phosphate Tablets, USP CIII 300 mg/30 mg Rx Only 71335-0545-6 2024-01-30 Acetaminophen and Codeine Phosphate Tablets, USP CIII 300 mg/30 mg Rx Only 71335-0545-7 2024-01-30 Acetaminophen and Codeine Phosphate Tablets, USP CIII 300 mg/30 mg Rx Only 71335-0545-8 2024-01-30 Acetaminophen and Codeine Phosphate Tablets, USP CIII 300 mg/30 mg Rx Only 71335-0545-9 2024-01-30 Acetaminophen and Codeine Phosphate Tablets, USP CIII 300 mg/30 mg Rx Only
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71335-0545-0 Acetaminophen and Codeine 40 in 1 BOTTLE TABLET 40 8 71335-0545-1 Acetaminophen and Codeine 6 in 1 BOTTLE TABLET 6 8 71335-0545-2 Acetaminophen and Codeine 20 in 1 BOTTLE TABLET 20 8 71335-0545-3 Acetaminophen and Codeine 30 in 1 BOTTLE TABLET 30 8 71335-0545-4 Acetaminophen and Codeine 84 in 1 BOTTLE TABLET 84 8 71335-0545-5 Acetaminophen and Codeine 15 in 1 BOTTLE TABLET 15 8 71335-0545-6 Acetaminophen and Codeine 120 in 1 BOTTLE TABLET 120 8 71335-0545-7 Acetaminophen and Codeine 100 in 1 BOTTLE TABLET 100 8 71335-0545-8 Acetaminophen and Codeine 60 in 1 BOTTLE TABLET 60 8 71335-0545-9 Acetaminophen and Codeine 90 in 1 BOTTLE TABLET 90 8
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 ndc (product): 71335-0545 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 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
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 71335-0545-0 71335054500 40 TABLET in 1 BOTTLE (71335-0545-0) 40 tablet 2018-05-11 0000-00-00 No No Current 71335-0545-1 71335054501 6 TABLET in 1 BOTTLE (71335-0545-1) 6 tablet 2018-05-01 0000-00-00 No No Current 71335-0545-2 71335054502 20 TABLET in 1 BOTTLE (71335-0545-2) 20 tablet 2018-05-01 0000-00-00 No No Current 71335-0545-3 71335054503 30 TABLET in 1 BOTTLE (71335-0545-3) 30 tablet 2018-05-11 0000-00-00 No No Current 71335-0545-4 71335054504 84 TABLET in 1 BOTTLE (71335-0545-4) 84 tablet 2018-05-11 0000-00-00 No No Current 71335-0545-5 71335054505 15 TABLET in 1 BOTTLE (71335-0545-5) 15 tablet 2018-05-11 0000-00-00 No No Current 71335-0545-6 71335054506 120 TABLET in 1 BOTTLE (71335-0545-6) 120 tablet 2018-05-11 0000-00-00 No No Current 71335-0545-7 71335054507 100 TABLET in 1 BOTTLE (71335-0545-7) 100 tablet 2018-05-11 0000-00-00 No No Current 71335-0545-8 71335054508 60 TABLET in 1 BOTTLE (71335-0545-8) 60 tablet 2018-05-11 0000-00-00 No No Current 71335-0545-9 71335054509 90 TABLET in 1 BOTTLE (71335-0545-9) 90 tablet 2018-05-11 0000-00-00 No No Current