Home NDC 68788-8881 Acetaminophen and Codeine Phosphate
Product NDC 68788-8881
11-digit product format 687888881
Labeler code 68788
Product ID 68788-8881_caa96b80-d8a7-4920-9d5c-717435e798de
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Acetaminophen and Codeine Phosphate
Dosage form TABLET
Route ORAL
Labeler Preferred Pharmaceuticals Inc.
Application ANDA089828
Marketing category ANDA
Marketing start 2025-06-02
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 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 A089828-001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;60MG 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 A089828-001 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 A089828-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;60MG TABLET / ORAL AA 1988-09-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 A089828-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;60MG TABLET / ORAL AA 1988-09-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A089828-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;60MG TABLET / ORAL AA 1988-09-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A089828-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;60MG TABLET / ORAL AA 1988-09-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A089828-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;60MG TABLET / ORAL AA 1988-09-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A089828-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;60MG TABLET / ORAL AA 1988-09-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A089828-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;60MG TABLET / ORAL AA 1988-09-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A089828-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;60MG TABLET / ORAL AA 1988-09-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A089828-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;60MG TABLET / ORAL AA 1988-09-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A089828-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;60MG TABLET / ORAL AA 1988-09-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A089828-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;60MG TABLET / ORAL AA 1988-09-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A089828-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;60MG TABLET / ORAL AA 1988-09-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A089828-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;60MG TABLET / ORAL AA 1988-09-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A089828-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;60MG TABLET / ORAL AA 1988-09-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A089828-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;60MG TABLET / ORAL AA 1988-09-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A089828-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;60MG TABLET / ORAL AA 1988-09-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A089828-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;60MG TABLET / ORAL 1988-09-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A089828-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;60MG TABLET / ORAL 1988-09-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A089828-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;60MG TABLET / ORAL 1988-09-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A089828-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;60MG TABLET / ORAL AA 1988-09-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A089828-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;60MG TABLET / ORAL 1988-09-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A089828-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;60MG TABLET / ORAL 1988-09-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A089828-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;60MG TABLET / ORAL AA 1988-09-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A089828-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;60MG TABLET / ORAL AA 1988-09-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A089828-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;60MG TABLET / ORAL AA 1988-09-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A089828-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;60MG TABLET / ORAL AA 1988-09-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A089828-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;60MG TABLET / ORAL AA 1988-09-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A089828-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;60MG TABLET / ORAL AA 1988-09-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A089828-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;60MG TABLET / ORAL AA 1988-09-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A089828-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;60MG TABLET / ORAL 1988-09-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A089828-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;60MG TABLET / ORAL 1988-09-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A089828-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;60MG TABLET / ORAL 1988-09-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A089828-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;60MG TABLET / ORAL 1988-09-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A089828-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;60MG TABLET / ORAL 1988-09-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A089828-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;60MG TABLET / ORAL 1988-09-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A089828-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;60MG TABLET / ORAL 1988-09-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A089828-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;60MG TABLET / ORAL 1988-09-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A089828-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;60MG TABLET / ORAL 1988-09-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A089828-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;60MG TABLET / ORAL 1988-09-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A089828-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;60MG 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 60 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 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 68788-8881-1 Acetaminophen and Codeine Phosphate 15 in 1 BOTTLE TABLET 15 1 68788-8881-3 Acetaminophen and Codeine Phosphate 30 in 1 BOTTLE TABLET 30 1 68788-8881-6 Acetaminophen and Codeine Phosphate 60 in 1 BOTTLE TABLET 60 1
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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Acetaminophen and Codeine Phosphate ACETAMINOPHEN AND CODEINE PHOSPHATE Bryant Ranch Prepack 3e41e55f-7e41-4653-aadb-32a9e47962d9 2025-10-22 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 089828 application number: ANDA089828 Acetaminophen and Codeine Phosphate ACETAMINOPHEN AND CODEINE PHOSPHATE Advanced Rx of Tennessee, LLC 36988ba2-cefd-99f8-e063-6294a90aa41a 2025-06-02 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 089828 application number: ANDA089828 Acetaminophen and Codeine Phosphate ACETAMINOPHEN AND CODEINE PHOSPHATE Preferred Pharmaceuticals Inc. caa96b80-d8a7-4920-9d5c-717435e798de 2025-06-02 Warnings, Adverse reactions Exact identifier application applno (ANDA): 089828 application number: ANDA089828 ndc (product): 68788-8881 Acetaminophen and Codeine Phosphate ACETAMINOPHEN AND CODEINE PHOSPHATE Strides Pharma Science Limited c459ed02-afd6-4533-82b6-bfb2c7ab0e72 2024-05-20 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 089828 application number: ANDA089828
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 68788-8881-1 68788888101 15 TABLET in 1 BOTTLE (68788-8881-1) 15 tablet 2025-06-02 No No Current 68788-8881-3 68788888103 30 TABLET in 1 BOTTLE (68788-8881-3) 30 tablet 2025-06-02 No No Current 68788-8881-6 68788888106 60 TABLET in 1 BOTTLE (68788-8881-6) 60 tablet 2025-06-02 No No Current