Home NDC 43386-493 Oxycodone and Acetaminophen
Product NDC 43386-493
11-digit product format 433860493
Labeler code 43386
Product ID 43386-493_5e566e5f-2fef-4d70-8cfe-c24b13659b8e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Oxycodone and Acetaminophen
Dosage form TABLET
Route ORAL
Labeler Lupin Pharmaceuticals,Inc.
Application ANDA204407
Marketing category ANDA
Marketing start 2017-02-24
Substance OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN
Active strength 10; 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 43 .
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 A204407-001 OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;2.5MG TABLET / ORAL AA 2017-02-24 A204407-002 OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;5MG TABLET / ORAL AA 2017-02-24 A204407-003 OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;7.5MG TABLET / ORAL AA 2017-02-24 A204407-004 OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;10MG TABLET / ORAL AA 2017-02-24
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 · 172 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 A204407-001 OXYCODONE AND ACETAMINOPHEN 325MG;2.5MG TABLET / ORAL AA 2017-02-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 A204407-002 OXYCODONE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2017-02-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 A204407-003 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2017-02-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 A204407-004 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2017-02-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 A204407-001 OXYCODONE AND ACETAMINOPHEN 325MG;2.5MG TABLET / ORAL AA 2017-02-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204407-002 OXYCODONE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2017-02-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204407-003 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2017-02-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204407-004 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2017-02-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204407-001 OXYCODONE AND ACETAMINOPHEN 325MG;2.5MG TABLET / ORAL AA 2017-02-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204407-002 OXYCODONE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2017-02-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204407-003 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2017-02-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204407-004 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2017-02-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204407-001 OXYCODONE AND ACETAMINOPHEN 325MG;2.5MG TABLET / ORAL AA 2017-02-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204407-002 OXYCODONE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2017-02-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204407-003 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2017-02-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204407-004 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2017-02-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204407-001 OXYCODONE AND ACETAMINOPHEN 325MG;2.5MG TABLET / ORAL AA 2017-02-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204407-002 OXYCODONE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2017-02-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204407-003 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2017-02-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204407-004 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2017-02-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204407-001 OXYCODONE AND ACETAMINOPHEN 325MG;2.5MG TABLET / ORAL AA 2017-02-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204407-002 OXYCODONE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2017-02-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204407-003 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2017-02-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204407-004 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2017-02-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204407-001 OXYCODONE AND ACETAMINOPHEN 325MG;2.5MG TABLET / ORAL AA 2017-02-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204407-002 OXYCODONE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2017-02-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204407-003 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2017-02-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204407-004 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2017-02-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204407-001 OXYCODONE AND ACETAMINOPHEN 325MG;2.5MG TABLET / ORAL AA 2017-02-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204407-002 OXYCODONE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2017-02-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204407-003 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2017-02-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204407-004 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2017-02-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204407-001 OXYCODONE AND ACETAMINOPHEN 325MG;2.5MG TABLET / ORAL AA 2017-02-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204407-002 OXYCODONE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2017-02-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204407-003 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2017-02-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204407-004 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2017-02-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204407-001 OXYCODONE AND ACETAMINOPHEN 325MG;2.5MG TABLET / ORAL AA 2017-02-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204407-002 OXYCODONE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2017-02-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204407-003 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2017-02-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204407-004 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2017-02-24 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 172 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 10 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1049214 Internal RxNorm lookup 1049221 Internal RxNorm lookup 1049225 Internal RxNorm lookup 1049635 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 43386-493-01 Oxycodone and Acetaminophen 100 in 1 BOTTLE TABLET 100 8 43386-493-05 Oxycodone and Acetaminophen 500 in 1 BOTTLE TABLET 500 8 43386-493-10 Oxycodone and Acetaminophen 1000 in 1 BOTTLE TABLET 1000 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43386-493 OXYCODONE AND ACETAMINOPHEN TABLET [LUPIN PHARMACEUTICALS,INC.] 8 Current NDC, Legacy NDC, 3 package rows 20241204_916ff456-a27e-49dc-a312-274126a8c30c.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 43386-493-01 43386049301 100 TABLET in 1 BOTTLE (43386-493-01) 100 tablet 2017-02-24 0000-00-00 No No Current 43386-493-05 43386049305 500 TABLET in 1 BOTTLE (43386-493-05) 500 tablet 2017-02-24 0000-00-00 No No Current 43386-493-10 43386049310 1000 TABLET in 1 BOTTLE (43386-493-10) 1000 tablet 2017-02-24 0000-00-00 No No Current