Home NDC 60760-581-30 ACETAMINOPHEN AND CODEINE PHOSPHATE
Product NDC 60760-581
Requested package NDC 60760-581-30
11-digit product format 607600581
Labeler code 60760
Product ID 60760-581_54cf59d2-356e-4636-e063-6394a90a54f3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name acetaminophen and codeine phosphate
Dosage form TABLET
Route ORAL
Labeler St. Mary's Medical Park Pharmacy
Application ANDA040419
Marketing category ANDA
Marketing start 2022-09-30
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 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 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 · 132 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 A040419-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;15MG TABLET / ORAL AA RS 2001-05-31 c2088c7a36db…2026-10-15 13:18:30 2026-09 A040419-002 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;30MG TABLET / ORAL AA RS 2001-05-31 c2088c7a36db…2026-10-15 13:18:30 2026-09 A040419-003 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;60MG TABLET / ORAL AA RS 2001-05-31 c2088c7a36db…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 132 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base ACETAMINOPHEN AND CODEINE PHOSPHATE
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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 60760-581-30 ACETAMINOPHEN AND CODEINE PHOSPHATE 30 in 1 BOTTLE, PLASTIC TABLET 30 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60760-581 ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [ST. MARY'S MEDICAL PARK PHARMACY] 1 Current NDC, Legacy NDC, 1 package rows 20221027_eac5f350-93e5-4dc2-e053-2a95a90aed60.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.
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 60760-581-30 60760058130 30 TABLET in 1 BOTTLE, PLASTIC (60760-581-30) 30 tablet 2022-09-30 0000-00-00 No No Current