Home NDC 67544-003 ACETAMINOPHEN AND CODEINE PHOSPHATE
Product NDC 67544-003
11-digit product format 675440003
Labeler code 67544
Product ID 67544-003_c4cf2f28-c73e-4370-843e-487b7b42e077
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
Substance ACETAMINOPHEN; CODEINE PHOSPHATE
Active strength 300; 60 mg/1; mg/1
Pharmacologic classes Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule CIII
NDC exclude flag No
Listing certified through 2026-12-31
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 1 · 6 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.
Additional Listing Data#
Finished product Yes
Brand name base ACETAMINOPHEN AND CODEINE PHOSPHATE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 300 mg/1 CODEINE PHOSPHATE 60 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination GSL05Y1MN6 Internal UNII lookup 362O9ITL9D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 993770 Internal RxNorm lookup 993781 Internal RxNorm lookup 993890 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 67544-003-53 ACETAMINOPHEN AND CODEINE PHOSPHATE 60 in 1 BOTTLE, PLASTIC TABLET 60 5 67544-003-60 ACETAMINOPHEN AND CODEINE PHOSPHATE 90 in 1 BOTTLE, PLASTIC TABLET 90 5 67544-003-70 ACETAMINOPHEN AND CODEINE PHOSPHATE 120 in 1 BOTTLE, PLASTIC TABLET 120 5 67544-003-80 ACETAMINOPHEN AND CODEINE PHOSPHATE 180 in 1 BOTTLE, PLASTIC TABLET 180 5 67544-003-90 ACETAMINOPHEN AND CODEINE PHOSPHATE 240 in 1 BOTTLE, PLASTIC TABLET 240 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 CODEINE PHOSPHATE ACTIVE INGREDIENT GSL05Y1MN6 ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 CODEINE ANHYDROUS ACTIVE MOIETY UX6OWY2V7J ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 POVIDONES INACTIVE INGREDIENT FZ989GH94E ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67544-003 ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 5 Current NDC, Legacy NDC, 5 package rows 20250110_d53bf9b7-1652-4287-a0c1-e89f6f0cb7f1.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 67544-003-53 67544000353 60 TABLET in 1 BOTTLE, PLASTIC (67544-003-53) 60 tablet 2011-07-06 0000-00-00 No No Current 67544-003-60 67544000360 90 TABLET in 1 BOTTLE, PLASTIC (67544-003-60) 90 tablet 2011-07-06 0000-00-00 No No Current 67544-003-70 67544000370 120 TABLET in 1 BOTTLE, PLASTIC (67544-003-70) 120 tablet 2011-07-06 0000-00-00 No No Current 67544-003-80 67544000380 180 TABLET in 1 BOTTLE, PLASTIC (67544-003-80) 180 tablet 2011-07-06 0000-00-00 No No Current 67544-003-90 67544000390 240 TABLET in 1 BOTTLE, PLASTIC (67544-003-90) 240 tablet 2011-07-06 0000-00-00 No No Current