Home NDC 71335-0701 Acetaminophen and Codeine Phosphate
Product NDC 71335-0701
11-digit product format 713350701
Labeler code 71335
Product ID 71335-0701_b3eeebc3-05cf-4e86-bdef-5d721e79d1fe
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Acetaminophen and Codeine Phosphate
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA088629
Marketing category ANDA
Marketing start 1990-09-30
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 2023-12-31
Current FDA listing Historical FDA.report record
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 · 165 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 RLD / RS Approval date A088629-001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;60MG TABLET / ORAL RLD 1985-03-06 A088629-002 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;15MG TABLET / ORAL 1985-03-06 A088629-003 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;30MG TABLET / ORAL 1985-03-06
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 3 · 116 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 2026-10-15 13:18:30 2026-09 A088629-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;60MG TABLET / ORAL RLD 1985-03-06 c2088c7a36db…2026-10-15 13:18:30 2026-09 A088629-002 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;15MG TABLET / ORAL 1985-03-06 c2088c7a36db…2026-10-15 13:18:30 2026-09 A088629-003 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;30MG TABLET / ORAL 1985-03-06 c2088c7a36db…2026-09-14 22:38:34 2026-08 A088629-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;60MG TABLET / ORAL RLD 1985-03-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A088629-002 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;15MG TABLET / ORAL 1985-03-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A088629-003 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;30MG TABLET / ORAL 1985-03-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 A088629-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;60MG TABLET / ORAL RLD 1985-03-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A088629-002 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;15MG TABLET / ORAL 1985-03-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A088629-003 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;30MG TABLET / ORAL 1985-03-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A088629-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;60MG TABLET / ORAL RLD 1985-03-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A088629-002 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;15MG TABLET / ORAL 1985-03-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A088629-003 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;30MG TABLET / ORAL 1985-03-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A088629-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;60MG TABLET / ORAL RLD 1985-03-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A088629-002 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;15MG TABLET / ORAL 1985-03-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A088629-003 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;30MG TABLET / ORAL 1985-03-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A088629-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;60MG TABLET / ORAL RLD 1985-03-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A088629-002 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;15MG TABLET / ORAL 1985-03-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A088629-003 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;30MG TABLET / ORAL 1985-03-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A088629-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;60MG TABLET / ORAL RLD 1985-03-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A088629-002 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;15MG TABLET / ORAL 1985-03-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A088629-003 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;30MG TABLET / ORAL 1985-03-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A088629-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;60MG TABLET / ORAL RLD 1985-03-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A088629-002 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;15MG TABLET / ORAL 1985-03-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A088629-003 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;30MG TABLET / ORAL 1985-03-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A088629-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;60MG TABLET / ORAL RLD 1985-03-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A088629-002 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;15MG TABLET / ORAL 1985-03-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A088629-003 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;30MG TABLET / ORAL 1985-03-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A088629-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;60MG TABLET / ORAL RLD 1985-03-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A088629-002 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;15MG TABLET / ORAL 1985-03-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A088629-003 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;30MG TABLET / ORAL 1985-03-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A088629-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;60MG TABLET / ORAL RLD 1985-03-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A088629-002 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;15MG TABLET / ORAL 1985-03-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A088629-003 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;30MG TABLET / ORAL 1985-03-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A088629-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;60MG TABLET / ORAL RLD 1985-03-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A088629-002 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;15MG TABLET / ORAL 1985-03-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A088629-003 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;30MG TABLET / ORAL 1985-03-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A088629-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;60MG TABLET / ORAL RLD 1985-03-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A088629-002 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;15MG TABLET / ORAL 1985-03-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A088629-003 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;30MG TABLET / ORAL 1985-03-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A088629-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;60MG TABLET / ORAL RLD 1985-03-06 79d66fd596c7…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A088629-003 AA 1 cb3db0bc1861…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Related label table NDC Related label 71335-0701-0 Acetaminophen and Codeine Phosphate Tablets, USP CIII Rx only 71335-0701-1 Acetaminophen and Codeine Phosphate Tablets, USP CIII Rx only 71335-0701-2 Acetaminophen and Codeine Phosphate Tablets, USP CIII Rx only 71335-0701-3 Acetaminophen and Codeine Phosphate Tablets, USP CIII Rx only 71335-0701-4 Acetaminophen and Codeine Phosphate Tablets, USP CIII Rx only 71335-0701-5 Acetaminophen and Codeine Phosphate Tablets, USP CIII Rx only 71335-0701-6 Acetaminophen and Codeine Phosphate Tablets, USP CIII Rx only 71335-0701-7 Acetaminophen and Codeine Phosphate Tablets, USP CIII Rx only 71335-0701-8 Acetaminophen and Codeine Phosphate Tablets, USP CIII Rx only 71335-0701-9 Acetaminophen and Codeine Phosphate Tablets, USP CIII Rx only
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71335-0701-0 Acetaminophen and Codeine Phosphate 100 in 1 BOTTLE TABLET 100 4 71335-0701-1 Acetaminophen and Codeine Phosphate 30 in 1 BOTTLE TABLET 30 4 71335-0701-2 Acetaminophen and Codeine Phosphate 120 in 1 BOTTLE TABLET 120 4 71335-0701-3 Acetaminophen and Codeine Phosphate 60 in 1 BOTTLE TABLET 60 4 71335-0701-4 Acetaminophen and Codeine Phosphate 90 in 1 BOTTLE TABLET 90 4 71335-0701-5 Acetaminophen and Codeine Phosphate 40 in 1 BOTTLE TABLET 40 4 71335-0701-6 Acetaminophen and Codeine Phosphate 20 in 1 BOTTLE TABLET 20 4 71335-0701-7 Acetaminophen and Codeine Phosphate 112 in 1 BOTTLE TABLET 112 4 71335-0701-8 Acetaminophen and Codeine Phosphate 84 in 1 BOTTLE TABLET 84 4 71335-0701-9 Acetaminophen and Codeine Phosphate 15 in 1 BOTTLE TABLET 15 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-0701 ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [BRYANT RANCH PREPACK] 4 Legacy NDC, 10 package rows 20220129_b3eeebc3-05cf-4e86-bdef-5d721e79d1fe.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 71335-0701-0 71335070100 100 TABLET in 1 BOTTLE (71335-0701-0) 100 tablet 2021-12-27 0000-00-00 No No Current 71335-0701-1 71335070101 30 TABLET in 1 BOTTLE (71335-0701-1) 30 tablet 2010-04-28 0000-00-00 No No Current 71335-0701-2 71335070102 120 TABLET in 1 BOTTLE (71335-0701-2) 120 tablet 2010-04-28 0000-00-00 No No Current 71335-0701-3 71335070103 60 TABLET in 1 BOTTLE (71335-0701-3) 60 tablet 2010-04-28 0000-00-00 No No Current 71335-0701-4 71335070104 90 TABLET in 1 BOTTLE (71335-0701-4) 90 tablet 2010-04-28 0000-00-00 No No Current 71335-0701-5 71335070105 40 TABLET in 1 BOTTLE (71335-0701-5) 40 tablet 2010-04-28 0000-00-00 No No Current 71335-0701-6 71335070106 20 TABLET in 1 BOTTLE (71335-0701-6) 20 tablet 2010-04-28 0000-00-00 No No Current 71335-0701-7 71335070107 112 TABLET in 1 BOTTLE (71335-0701-7) 112 tablet 2010-04-28 0000-00-00 No No Current 71335-0701-8 71335070108 84 TABLET in 1 BOTTLE (71335-0701-8) 84 tablet 2010-04-28 0000-00-00 No No Current 71335-0701-9 71335070109 15 TABLET in 1 BOTTLE (71335-0701-9) 15 tablet 2010-04-28 0000-00-00 No No Current