Home NDC 49999-026 ACETAMINOPHEN AND CODEINE PHOSPHATE
Product NDC 49999-026
11-digit product format 499990026
Labeler code 49999
Product ID 49999-026_f2dc64fe-6c56-4bfc-a7af-447cce174394
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name acetaminophen and codeine phosphate
Dosage form TABLET
Route ORAL
Labeler Quality Care Products 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 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 1 · 27 matching rows.
View current auxiliary records. · View the auxiliary file history.
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.
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 49999-026-30 49999002630 30 TABLET in 1 BOTTLE (49999-026-30) 30 tablet 2011-07-06 0000-00-00 No No Current 49999-026-60 49999002660 60 TABLET in 1 BOTTLE (49999-026-60) 60 tablet 2011-07-06 0000-00-00 No No Current