Home NDC 63187-721 Oxycodone and Acetaminophen
Product NDC 63187-721
11-digit product format 631870721
Labeler code 63187
Product ID 63187-721_b6da114d-fc88-4f72-9055-a963b4625f25
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Oxycodone and Acetaminophen
Dosage form TABLET
Route ORAL
Labeler Proficient Rx LP
Application ANDA040778
Marketing category ANDA
Marketing start 2007-11-27
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 2027-12-31
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A040778-001 OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;10MG TABLET / ORAL AA 2007-11-27 A040778-002 OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;7.5MG TABLET / ORAL AA 2014-06-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 3 · 86 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 A040778-001 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2007-11-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A040778-002 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2014-06-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 A040778-001 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2007-11-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040778-002 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2014-06-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040778-001 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2007-11-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040778-002 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2014-06-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040778-001 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2007-11-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040778-002 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2014-06-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040778-001 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2007-11-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040778-002 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2014-06-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040778-001 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2007-11-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040778-002 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2014-06-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040778-001 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2007-11-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040778-002 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2014-06-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040778-001 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2007-11-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040778-002 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2014-06-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040778-001 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2007-11-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040778-002 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2014-06-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040778-001 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2007-11-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040778-002 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2014-06-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040778-001 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2007-11-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040778-002 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2014-06-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040778-001 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2007-11-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A040778-002 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2014-06-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040778-001 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2007-11-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040778-002 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2014-06-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040778-001 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2007-11-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040778-002 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2014-06-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040778-001 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2007-11-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040778-002 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2014-06-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040778-001 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2007-11-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A040778-002 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2014-06-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040778-001 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2007-11-27 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040778-002 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2014-06-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040778-001 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2007-11-27 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A040778-002 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2014-06-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040778-001 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2007-11-27 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A040778-002 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2014-06-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040778-001 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2007-11-27 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A040778-002 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2014-06-27 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 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 2027-12-31 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 C1ENJ2TE6C Internal UNII lookup 362O9ITL9D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1049214 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 63187-721-15 Oxycodone and Acetaminophen 15 in 1 BOTTLE TABLET 15 4 63187-721-20 Oxycodone and Acetaminophen 20 in 1 BOTTLE TABLET 20 4 63187-721-30 Oxycodone and Acetaminophen 30 in 1 BOTTLE TABLET 30 4 63187-721-60 Oxycodone and Acetaminophen 60 in 1 BOTTLE TABLET 60 4 63187-721-90 Oxycodone and Acetaminophen 90 in 1 BOTTLE TABLET 90 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63187-721 OXYCODONE AND ACETAMINOPHEN TABLET [PROFICIENT RX LP] 4 Current NDC, Legacy NDC, 5 package rows 20191121_6253b3ae-bb52-4532-8d1f-756c0b1577c7.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 · 4 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 63187-721-15 63187072115 15 TABLET in 1 BOTTLE (63187-721-15) 15 tablet 2016-06-01 0000-00-00 No No Current 63187-721-20 63187072120 20 TABLET in 1 BOTTLE (63187-721-20) 20 tablet 2016-06-01 0000-00-00 No No Current 63187-721-30 63187072130 30 TABLET in 1 BOTTLE (63187-721-30) 30 tablet 2016-06-01 0000-00-00 No No Current 63187-721-60 63187072160 60 TABLET in 1 BOTTLE (63187-721-60) 60 tablet 2016-06-01 0000-00-00 No No Current 63187-721-90 63187072190 90 TABLET in 1 BOTTLE (63187-721-90) 90 tablet 2017-05-30 0000-00-00 No No Current