Home NDC 71610-111 ACETAMINOPHEN AND CODEINE PHOSPHATE
Product NDC 71610-111
11-digit product format 716100111
Labeler code 71610
Product ID 71610-111_c998316d-8c03-4d5a-a57c-3d63398d85de
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name acetaminophen and codeine phosphate
Dosage form TABLET
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application ANDA040419
Marketing category ANDA
Marketing start 2011-07-06
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A040419-001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;15MG TABLET / ORAL AA RS 2001-05-31 A040419-002 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;30MG TABLET / ORAL AA RS 2001-05-31 A040419-003 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;60MG TABLET / ORAL AA RS 2001-05-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 4 · 129 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 2026-09-14 22:38:34 2026-08 A040419-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;15MG TABLET / ORAL AA RS 2001-05-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 A040419-002 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;30MG TABLET / ORAL AA RS 2001-05-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 A040419-003 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;60MG TABLET / ORAL AA RS 2001-05-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 A040419-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;15MG TABLET / ORAL AA RS 2001-05-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040419-002 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;30MG TABLET / ORAL AA RS 2001-05-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040419-003 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;60MG TABLET / ORAL AA RS 2001-05-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040419-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;15MG TABLET / ORAL AA RS 2001-05-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040419-002 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;30MG TABLET / ORAL AA RS 2001-05-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040419-003 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;60MG TABLET / ORAL AA RS 2001-05-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040419-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;15MG TABLET / ORAL AA RS 2001-05-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040419-002 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;30MG TABLET / ORAL AA RS 2001-05-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040419-003 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;60MG TABLET / ORAL AA RS 2001-05-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040419-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;15MG TABLET / ORAL AA RS 2001-05-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040419-002 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;30MG TABLET / ORAL AA RS 2001-05-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040419-003 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;60MG TABLET / ORAL AA RS 2001-05-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040419-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;15MG TABLET / ORAL AA RS 2001-05-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040419-002 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;30MG TABLET / ORAL AA RS 2001-05-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040419-003 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;60MG TABLET / ORAL AA RS 2001-05-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040419-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;15MG TABLET / ORAL AA RS 2001-05-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040419-002 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;30MG TABLET / ORAL AA RS 2001-05-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040419-003 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;60MG TABLET / ORAL AA RS 2001-05-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040419-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;15MG TABLET / ORAL AA RS 2001-05-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040419-002 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;30MG TABLET / ORAL AA RS 2001-05-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040419-003 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;60MG TABLET / ORAL AA RS 2001-05-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040419-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;15MG TABLET / ORAL AA RS 2001-05-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040419-002 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;30MG TABLET / ORAL AA RS 2001-05-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040419-003 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;60MG TABLET / ORAL AA RS 2001-05-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040419-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;15MG TABLET / ORAL AA RS 2001-05-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040419-002 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;30MG TABLET / ORAL AA RS 2001-05-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040419-003 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;60MG TABLET / ORAL AA RS 2001-05-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040419-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;15MG TABLET / ORAL AA RS 2001-05-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040419-002 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;30MG TABLET / ORAL AA RS 2001-05-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040419-003 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;60MG TABLET / ORAL AA RS 2001-05-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040419-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;15MG TABLET / ORAL AA RS 2001-05-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A040419-002 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;30MG TABLET / ORAL AA RS 2001-05-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A040419-003 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;60MG TABLET / ORAL AA RS 2001-05-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040419-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;15MG TABLET / ORAL AA RS 2001-05-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040419-002 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;30MG TABLET / ORAL AA RS 2001-05-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040419-003 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;60MG TABLET / ORAL AA RS 2001-05-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040419-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;15MG TABLET / ORAL AA RS 2001-05-31 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71610-111 ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 Legacy NDC 20180828_0b4e335b-afd3-4a87-81de-efb8fa41ae33.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 2 of 2 · 21 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 71610-111-30 71610011130 30 TABLET in 1 BOTTLE (71610-111-30) 30 tablet 2018-08-09 0000-00-00 No No Current 71610-111-45 71610011145 45 TABLET in 1 BOTTLE (71610-111-45) 45 tablet 2018-08-09 0000-00-00 No No Current 71610-111-46 71610011146 56 TABLET in 1 BOTTLE (71610-111-46) 56 tablet 2018-08-06 0000-00-00 No No Current 71610-111-53 71610011153 60 TABLET in 1 BOTTLE (71610-111-53) 60 tablet 2018-08-09 0000-00-00 No No Current 71610-111-54 71610011154 84 TABLET in 1 BOTTLE (71610-111-54) 84 tablet 2018-08-06 0000-00-00 No No Current 71610-111-60 71610011160 90 TABLET in 1 BOTTLE (71610-111-60) 90 tablet 2018-08-09 0000-00-00 No No Current 71610-111-70 71610011170 120 TABLET in 1 BOTTLE (71610-111-70) 120 tablet 2018-08-09 0000-00-00 No No Current 71610-111-72 71610011172 112 TABLET in 1 BOTTLE (71610-111-72) 112 tablet 2018-08-06 0000-00-00 No No Current 71610-111-75 71610011175 150 TABLET in 1 BOTTLE (71610-111-75) 150 tablet 2018-08-06 0000-00-00 No No Current 71610-111-80 71610011180 180 TABLET in 1 BOTTLE (71610-111-80) 180 tablet 2018-08-09 0000-00-00 No No Current 71610-111-90 71610011190 240 TABLET in 1 BOTTLE (71610-111-90) 240 tablet 2018-08-09 0000-00-00 No No Current