Home NDC 76420-763 Oxycodone hydrochloride
Product NDC 76420-763
11-digit product format 764200763
Labeler code 76420
Product ID 76420-763_1bb160c8-a76d-7033-e063-6294a90adbef
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Oxycodone hydrochloride
Dosage form TABLET
Route ORAL
Labeler Asclemed USA, Inc.
Application ANDA202116
Marketing category ANDA
Marketing start 2011-12-30
Substance OXYCODONE HYDROCHLORIDE
Active strength 5 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 42 .
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 A202116-001 OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-12-30 A202116-002 OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2011-12-30 A202116-003 OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2011-12-30
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 · 126 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 2026-08-18 06:07:40 2026-07 A202116-001 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-12-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202116-002 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2011-12-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202116-003 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2011-12-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202116-001 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-12-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202116-002 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2011-12-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202116-003 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2011-12-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202116-001 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-12-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202116-002 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2011-12-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202116-003 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2011-12-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202116-001 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-12-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202116-002 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2011-12-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202116-003 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2011-12-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202116-001 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-12-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202116-002 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2011-12-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202116-003 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2011-12-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202116-001 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-12-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202116-002 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2011-12-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202116-003 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2011-12-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202116-001 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-12-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202116-002 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2011-12-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202116-003 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2011-12-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202116-001 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-12-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202116-002 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2011-12-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202116-003 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2011-12-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202116-001 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-12-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202116-002 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2011-12-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202116-003 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2011-12-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202116-001 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-12-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202116-002 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2011-12-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202116-003 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2011-12-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202116-001 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-12-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202116-002 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2011-12-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202116-003 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2011-12-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202116-001 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-12-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202116-002 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2011-12-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202116-003 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2011-12-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202116-001 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-12-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202116-002 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2011-12-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202116-003 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2011-12-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202116-001 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-12-30 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Oxycodone hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OXYCODONE HYDROCHLORIDE 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 1049611 Internal RxNorm lookup 1049618 Internal RxNorm lookup 1049621 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 76420-763-01 Oxycodone hydrochloride 100 in 1 BOTTLE TABLET 100 1 76420-763-05 Oxycodone hydrochloride 500 in 1 BOTTLE TABLET 500 1 76420-763-10 Oxycodone hydrochloride 10 in 1 BOTTLE TABLET 10 1 76420-763-20 Oxycodone hydrochloride 20 in 1 BOTTLE TABLET 20 1 76420-763-30 Oxycodone hydrochloride 30 in 1 BOTTLE TABLET 30 1 76420-763-60 Oxycodone hydrochloride 60 in 1 BOTTLE TABLET 60 1 76420-763-90 Oxycodone hydrochloride 90 in 1 BOTTLE TABLET 90 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76420-763 OXYCODONE HYDROCHLORIDE TABLET [ASCLEMED USA, INC.] 1 Current NDC, 7 package rows 20240626_1bb147d4-1ab6-dd70-e063-6394a90a67a8.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 76420-763-01 76420076301 100 TABLET in 1 BOTTLE (76420-763-01) 100 tablet 2024-06-25 No No Current 76420-763-05 76420076305 500 TABLET in 1 BOTTLE (76420-763-05) 500 tablet 2024-06-25 No No Current 76420-763-10 76420076310 10 TABLET in 1 BOTTLE (76420-763-10) 10 tablet 2024-06-25 No No Current 76420-763-20 76420076320 20 TABLET in 1 BOTTLE (76420-763-20) 20 tablet 2024-06-25 No No Current 76420-763-30 76420076330 30 TABLET in 1 BOTTLE (76420-763-30) 30 tablet 2024-06-25 No No Current 76420-763-60 76420076360 60 TABLET in 1 BOTTLE (76420-763-60) 60 tablet 2024-06-25 No No Current 76420-763-90 76420076390 90 TABLET in 1 BOTTLE (76420-763-90) 90 tablet 2024-06-25 No No Current