Home NDC 64380-448 Acetaminophen and Codeine Phosphate
Product NDC 64380-448
11-digit product format 643800448
Labeler code 64380
Product ID 64380-448_c87671eb-3ec7-4930-be25-5686a75679de
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Acetaminophen and Codeine Phosphate
Dosage form TABLET
Route ORAL
Labeler Strides Pharma Science Limited
Application ANDA089990
Marketing category ANDA
Marketing start 2024-05-20
Substance ACETAMINOPHEN; CODEINE PHOSPHATE
Active strength 300; 15 mg/1; mg/1
Pharmacologic classes Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule CII
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A089990-001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;15MG TABLET / ORAL AA 1988-09-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A089990-001 AA
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 2 · 43 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 A089990-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;15MG TABLET / ORAL AA 1988-09-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 A089990-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;15MG TABLET / ORAL AA 1988-09-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A089990-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;15MG TABLET / ORAL AA 1988-09-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A089990-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;15MG TABLET / ORAL AA 1988-09-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A089990-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;15MG TABLET / ORAL AA 1988-09-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A089990-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;15MG TABLET / ORAL AA 1988-09-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A089990-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;15MG TABLET / ORAL AA 1988-09-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A089990-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;15MG TABLET / ORAL AA 1988-09-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A089990-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;15MG TABLET / ORAL AA 1988-09-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A089990-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;15MG TABLET / ORAL AA 1988-09-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A089990-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;15MG TABLET / ORAL AA 1988-09-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A089990-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;15MG TABLET / ORAL AA 1988-09-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A089990-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;15MG TABLET / ORAL AA 1988-09-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A089990-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;15MG TABLET / ORAL AA 1988-09-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A089990-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;15MG TABLET / ORAL AA 1988-09-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A089990-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;15MG TABLET / ORAL AA 1988-09-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A089990-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;15MG TABLET / ORAL 1988-09-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A089990-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;15MG TABLET / ORAL 1988-09-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A089990-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;15MG TABLET / ORAL 1988-09-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A089990-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;15MG TABLET / ORAL AA 1988-09-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A089990-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;15MG TABLET / ORAL 1988-09-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A089990-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;15MG TABLET / ORAL 1988-09-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A089990-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;15MG TABLET / ORAL AA 1988-09-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A089990-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;15MG TABLET / ORAL AA 1988-09-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A089990-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;15MG TABLET / ORAL AA 1988-09-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A089990-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;15MG TABLET / ORAL AA 1988-09-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A089990-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;15MG TABLET / ORAL AA 1988-09-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A089990-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;15MG TABLET / ORAL AA 1988-09-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A089990-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;15MG TABLET / ORAL AA 1988-09-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A089990-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;15MG TABLET / ORAL 1988-09-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A089990-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;15MG TABLET / ORAL 1988-09-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A089990-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;15MG TABLET / ORAL 1988-09-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A089990-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;15MG TABLET / ORAL 1988-09-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A089990-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;15MG TABLET / ORAL 1988-09-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A089990-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;15MG TABLET / ORAL 1988-09-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A089990-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;15MG TABLET / ORAL 1988-09-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A089990-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;15MG TABLET / ORAL 1988-09-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A089990-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;15MG TABLET / ORAL 1988-09-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A089990-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;15MG TABLET / ORAL 1988-09-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A089990-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;15MG TABLET / ORAL 1988-09-30 f41ea6bd6efb…
Observed Orange Book normalized TE history# 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 15 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 · 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 64380-448-01 Acetaminophen and Codeine Phosphate 100 in 1 BOTTLE TABLET 100 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64380-448 ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [STRIDES PHARMA SCIENCE LIMITED] 1 Current NDC, 1 package rows 20240520_c459ed02-afd6-4533-82b6-bfb2c7ab0e72.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 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 64380-448-01 64380044801 100 TABLET in 1 BOTTLE (64380-448-01) 100 tablet 2024-05-20 No No Current