Home NDC 72887-683 oxycodone and acetaminophen
Product NDC 72887-683
11-digit product format 728870683
Labeler code 72887
Product ID 72887-683_57ab82a0-2dbe-236b-e063-6394a90a0ab8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name oxycodone and acetaminophen tablets
Dosage form TABLET
Route ORAL
Labeler FH2 Pharma LLC
Application ANDA040608
Marketing category ANDA
Marketing start 2020-07-01
Substance OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN
Active strength 10; 300 mg/1; mg/1
Pharmacologic classes Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule CII
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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A040608-001 OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 300MG;2.5MG TABLET / ORAL RS 2005-12-30 A040608-002 OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 300MG;5MG TABLET / ORAL RS 2005-12-30 A040608-003 OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 300MG;7.5MG TABLET / ORAL RS 2005-12-30 A040608-004 OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 300MG;10MG TABLET / ORAL RS 2005-12-30
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 5 · 176 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 A040608-001 OXYCODONE AND ACETAMINOPHEN 300MG;2.5MG TABLET / ORAL RS 2005-12-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 A040608-002 OXYCODONE AND ACETAMINOPHEN 300MG;5MG TABLET / ORAL RS 2005-12-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 A040608-003 OXYCODONE AND ACETAMINOPHEN 300MG;7.5MG TABLET / ORAL RS 2005-12-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 A040608-004 OXYCODONE AND ACETAMINOPHEN 300MG;10MG TABLET / ORAL RS 2005-12-30 c2088c7a36db…2026-09-14 22:38:34 2026-08 A040608-001 OXYCODONE AND ACETAMINOPHEN 300MG;2.5MG TABLET / ORAL RS 2005-12-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A040608-002 OXYCODONE AND ACETAMINOPHEN 300MG;5MG TABLET / ORAL RS 2005-12-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A040608-003 OXYCODONE AND ACETAMINOPHEN 300MG;7.5MG TABLET / ORAL RS 2005-12-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A040608-004 OXYCODONE AND ACETAMINOPHEN 300MG;10MG TABLET / ORAL RS 2005-12-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 A040608-001 OXYCODONE AND ACETAMINOPHEN 300MG;2.5MG TABLET / ORAL RS 2005-12-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040608-002 OXYCODONE AND ACETAMINOPHEN 300MG;5MG TABLET / ORAL RS 2005-12-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040608-003 OXYCODONE AND ACETAMINOPHEN 300MG;7.5MG TABLET / ORAL RS 2005-12-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040608-004 OXYCODONE AND ACETAMINOPHEN 300MG;10MG TABLET / ORAL RS 2005-12-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040608-001 OXYCODONE AND ACETAMINOPHEN 300MG;2.5MG TABLET / ORAL RS 2005-12-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040608-002 OXYCODONE AND ACETAMINOPHEN 300MG;5MG TABLET / ORAL RS 2005-12-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040608-003 OXYCODONE AND ACETAMINOPHEN 300MG;7.5MG TABLET / ORAL RS 2005-12-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040608-004 OXYCODONE AND ACETAMINOPHEN 300MG;10MG TABLET / ORAL RS 2005-12-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040608-001 OXYCODONE AND ACETAMINOPHEN 300MG;2.5MG TABLET / ORAL RS 2005-12-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040608-002 OXYCODONE AND ACETAMINOPHEN 300MG;5MG TABLET / ORAL RS 2005-12-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040608-003 OXYCODONE AND ACETAMINOPHEN 300MG;7.5MG TABLET / ORAL RS 2005-12-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040608-004 OXYCODONE AND ACETAMINOPHEN 300MG;10MG TABLET / ORAL RS 2005-12-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040608-001 OXYCODONE AND ACETAMINOPHEN 300MG;2.5MG TABLET / ORAL RS 2005-12-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040608-002 OXYCODONE AND ACETAMINOPHEN 300MG;5MG TABLET / ORAL RS 2005-12-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040608-003 OXYCODONE AND ACETAMINOPHEN 300MG;7.5MG TABLET / ORAL RS 2005-12-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040608-004 OXYCODONE AND ACETAMINOPHEN 300MG;10MG TABLET / ORAL RS 2005-12-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040608-001 OXYCODONE AND ACETAMINOPHEN 300MG;2.5MG TABLET / ORAL RS 2005-12-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040608-002 OXYCODONE AND ACETAMINOPHEN 300MG;5MG TABLET / ORAL RS 2005-12-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040608-003 OXYCODONE AND ACETAMINOPHEN 300MG;7.5MG TABLET / ORAL RS 2005-12-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040608-004 OXYCODONE AND ACETAMINOPHEN 300MG;10MG TABLET / ORAL RS 2005-12-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040608-001 OXYCODONE AND ACETAMINOPHEN 300MG;2.5MG TABLET / ORAL RS 2005-12-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040608-002 OXYCODONE AND ACETAMINOPHEN 300MG;5MG TABLET / ORAL RS 2005-12-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040608-003 OXYCODONE AND ACETAMINOPHEN 300MG;7.5MG TABLET / ORAL RS 2005-12-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040608-004 OXYCODONE AND ACETAMINOPHEN 300MG;10MG TABLET / ORAL RS 2005-12-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040608-001 OXYCODONE AND ACETAMINOPHEN 300MG;2.5MG TABLET / ORAL RS 2005-12-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040608-002 OXYCODONE AND ACETAMINOPHEN 300MG;5MG TABLET / ORAL RS 2005-12-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040608-003 OXYCODONE AND ACETAMINOPHEN 300MG;7.5MG TABLET / ORAL RS 2005-12-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040608-004 OXYCODONE AND ACETAMINOPHEN 300MG;10MG TABLET / ORAL RS 2005-12-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040608-001 OXYCODONE AND ACETAMINOPHEN 300MG;2.5MG TABLET / ORAL RS 2005-12-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040608-002 OXYCODONE AND ACETAMINOPHEN 300MG;5MG TABLET / ORAL RS 2005-12-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040608-003 OXYCODONE AND ACETAMINOPHEN 300MG;7.5MG TABLET / ORAL RS 2005-12-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040608-004 OXYCODONE AND ACETAMINOPHEN 300MG;10MG TABLET / ORAL RS 2005-12-30 2680178bc6a6…
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 oxycodone and acetaminophen
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OXYCODONE HYDROCHLORIDE 10 mg/1 ACETAMINOPHEN 300 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 C1ENJ2TE6C Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1014599 Internal RxNorm lookup 1014615 Internal RxNorm lookup 1014632 Internal RxNorm lookup 1037259 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 72887-683-03 oxycodone and acetaminophen 30 in 1 BOTTLE, PLASTIC TABLET 30 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72887-683 OXYCODONE AND ACETAMINOPHEN TABLET OXYCODONE AND ACETAMINOPHEN (OXYCODONE AND ACETAMINOPHEN TABLETS) TABLET [FH2 PHARMA LLC] 10 Current NDC, Legacy NDC, 1 package rows 20250223_88d97caf-bcf5-3cde-e053-2995a90acf4a.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 · 3 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 72887-683-03 72887068303 30 TABLET in 1 BOTTLE, PLASTIC (72887-683-03) 30 tablet 2020-09-25 0000-00-00 No No Current