Home NDC 0228-2983 Oxycodone and Acetaminophen
Product NDC 0228-2983
11-digit product format 002282983
Labeler code 0228
Product ID 0228-2983_690cb229-a230-4f23-9c93-0bec0ee691a0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Oxycodone and Acetaminophen
Dosage form TABLET
Route ORAL
Labeler Actavis Pharma, Inc.
Application ANDA201447
Marketing category ANDA
Marketing start 2013-11-27
Marketing end 2019-10-31
Substance OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN
Active strength 10 mg/1; mg/1
Pharmacologic classes Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule CII
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record
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 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A201447-001 OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;2.5MG TABLET / ORAL AA 2013-04-12 A201447-002 OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;5MG TABLET / ORAL AA 2013-04-12 A201447-003 OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;7.5MG TABLET / ORAL AA 2013-04-12 A201447-004 OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;10MG TABLET / ORAL AA 2013-04-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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 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 A201447-001 OXYCODONE AND ACETAMINOPHEN 325MG;2.5MG TABLET / ORAL AA 2013-04-12 c2088c7a36db…2026-10-15 13:18:30 2026-09 A201447-002 OXYCODONE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2013-04-12 c2088c7a36db…2026-10-15 13:18:30 2026-09 A201447-003 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2013-04-12 c2088c7a36db…2026-10-15 13:18:30 2026-09 A201447-004 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2013-04-12 c2088c7a36db…2026-09-14 22:38:34 2026-08 A201447-001 OXYCODONE AND ACETAMINOPHEN 325MG;2.5MG TABLET / ORAL AA 2013-04-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 A201447-002 OXYCODONE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2013-04-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 A201447-003 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2013-04-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 A201447-004 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2013-04-12 84e616aacf4f…2026-08-18 06:07:40 2026-07 A201447-001 OXYCODONE AND ACETAMINOPHEN 325MG;2.5MG TABLET / ORAL AA 2013-04-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A201447-002 OXYCODONE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2013-04-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A201447-003 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2013-04-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A201447-004 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2013-04-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A201447-001 OXYCODONE AND ACETAMINOPHEN 325MG;2.5MG TABLET / ORAL AA 2013-04-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201447-002 OXYCODONE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2013-04-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201447-003 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2013-04-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201447-004 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2013-04-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201447-001 OXYCODONE AND ACETAMINOPHEN 325MG;2.5MG TABLET / ORAL AA 2013-04-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201447-002 OXYCODONE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2013-04-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201447-003 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2013-04-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201447-004 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2013-04-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201447-001 OXYCODONE AND ACETAMINOPHEN 325MG;2.5MG TABLET / ORAL AA 2013-04-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201447-002 OXYCODONE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2013-04-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201447-003 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2013-04-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201447-004 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2013-04-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201447-001 OXYCODONE AND ACETAMINOPHEN 325MG;2.5MG TABLET / ORAL AA 2013-04-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201447-002 OXYCODONE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2013-04-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201447-003 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2013-04-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201447-004 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2013-04-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201447-001 OXYCODONE AND ACETAMINOPHEN 325MG;2.5MG TABLET / ORAL AA 2013-04-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201447-002 OXYCODONE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2013-04-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201447-003 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2013-04-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201447-004 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2013-04-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201447-001 OXYCODONE AND ACETAMINOPHEN 325MG;2.5MG TABLET / ORAL AA 2013-04-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201447-002 OXYCODONE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2013-04-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201447-003 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2013-04-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201447-004 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2013-04-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201447-001 OXYCODONE AND ACETAMINOPHEN 325MG;2.5MG TABLET / ORAL AA 2013-04-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201447-002 OXYCODONE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2013-04-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201447-003 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2013-04-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201447-004 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2013-04-12 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 5 of 5 · 176 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Socrata Ingredients# DailyMed RxNorm Mappings#