Home NDC 42806-115 Oxycodone and Acetaminophen
Product NDC 42806-115
11-digit product format 428060115
Labeler code 42806
Product ID 42806-115_5418fa2c-3b31-4aec-ad48-6ee7bff4dd27
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Oxycodone and Acetaminophen
Dosage form TABLET
Route ORAL
Labeler Epic Pharma, LLC
Application ANDA203864
Marketing category ANDA
Marketing start 2018-07-02
Substance OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN
Active strength 7.5; 325 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 44 .
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 A203864-001 OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;5MG TABLET / ORAL AA 2018-07-02 A203864-002 OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;7.5MG TABLET / ORAL AA 2018-07-02 A203864-003 OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;10MG TABLET / ORAL AA 2018-07-02
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 · 132 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 A203864-001 OXYCODONE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2018-07-02 c2088c7a36db…2026-10-15 13:18:30 2026-09 A203864-002 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2018-07-02 c2088c7a36db…2026-10-15 13:18:30 2026-09 A203864-003 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2018-07-02 c2088c7a36db…2026-09-14 22:38:34 2026-08 A203864-001 OXYCODONE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2018-07-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203864-002 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2018-07-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203864-003 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2018-07-02 84e616aacf4f…2026-08-18 06:07:40 2026-07 A203864-001 OXYCODONE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2018-07-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203864-002 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2018-07-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203864-003 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2018-07-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203864-001 OXYCODONE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2018-07-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203864-002 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2018-07-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203864-003 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2018-07-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203864-001 OXYCODONE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2018-07-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203864-002 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2018-07-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203864-003 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2018-07-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203864-001 OXYCODONE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2018-07-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203864-002 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2018-07-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203864-003 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2018-07-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203864-001 OXYCODONE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2018-07-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203864-002 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2018-07-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203864-003 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2018-07-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203864-001 OXYCODONE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2018-07-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203864-002 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2018-07-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203864-003 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2018-07-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203864-001 OXYCODONE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2018-07-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203864-002 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2018-07-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203864-003 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2018-07-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203864-001 OXYCODONE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2018-07-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203864-002 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2018-07-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203864-003 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2018-07-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203864-001 OXYCODONE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2018-07-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203864-002 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2018-07-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203864-003 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2018-07-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203864-001 OXYCODONE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2018-07-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203864-002 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2018-07-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203864-003 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2018-07-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203864-001 OXYCODONE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2018-07-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203864-002 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2018-07-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203864-003 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2018-07-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203864-001 OXYCODONE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2018-07-02 79d66fd596c7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 132 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 Oxycodone and Acetaminophen
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OXYCODONE HYDROCHLORIDE 7.5 mg/1 ACETAMINOPHEN 325 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1049214 Internal RxNorm lookup 1049221 Internal RxNorm lookup 1049225 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 42806-115-01 Oxycodone and Acetaminophen 100 in 1 BOTTLE TABLET 100 18
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42806-115 OXYCODONE AND ACETAMINOPHEN TABLET [EPIC PHARMA, LLC] 13 Current NDC, Legacy NDC, 1 package rows 20231221_700a229f-dc2d-7086-e053-2991aa0aec91.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 Marketing end Sample Exclude flag Status 42806-115-01 42806011501 100 TABLET in 1 BOTTLE (42806-115-01) 100 tablet 2018-07-02 0000-00-00 No No Current