Home NDC 47781-264 Oxycodone hydrochloride
Product NDC 47781-264
11-digit product format 477810264
Labeler code 47781
Product ID 47781-264_aa023689-6275-e0a0-ab08-d45edc45ec40
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Oxycodone hydrochloride
Dosage form TABLET
Route ORAL
Labeler Alvogen, Inc.
Application ANDA202116
Marketing category ANDA
Marketing start 2011-12-30
Substance OXYCODONE HYDROCHLORIDE
Active strength 15 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 1 .
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 · 123 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 2026-02-19 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…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202116-002 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2011-12-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202116-003 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2011-12-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202116-001 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-12-30 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Oxycodone hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OXYCODONE HYDROCHLORIDE 15 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 47781-264-01 Oxycodone hydrochloride 100 in 1 BOTTLE TABLET 100 18 47781-264-05 Oxycodone hydrochloride 500 in 1 BOTTLE TABLET 500 18
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded OXYCODONE HYDROCHLORIDE ACTIVE INGREDIENT C1ENJ2TE6C OXYCODONE HYDROCHLORIDE TABLET [ALVOGEN, INC.] 6 OXYCODONE ACTIVE MOIETY CD35PMG570 OXYCODONE HYDROCHLORIDE TABLET [ALVOGEN, INC.] 6 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U OXYCODONE HYDROCHLORIDE TABLET [ALVOGEN, INC.] 6 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G OXYCODONE HYDROCHLORIDE TABLET [ALVOGEN, INC.] 6 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK OXYCODONE HYDROCHLORIDE TABLET [ALVOGEN, INC.] 6 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 OXYCODONE HYDROCHLORIDE TABLET [ALVOGEN, INC.] 6 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ OXYCODONE HYDROCHLORIDE TABLET [ALVOGEN, INC.] 6 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP OXYCODONE HYDROCHLORIDE TABLET [ALVOGEN, INC.] 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 47781-264 OXYCODONE HYDROCHLORIDE TABLET [ALVOGEN, INC.] 17 Current NDC, Legacy NDC, 2 package rows 20250427_20bb6bb4-230a-c9c2-01d8-a6e9341e96ba.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 Marketing end Sample Exclude flag Status 47781-264-01 47781026401 100 TABLET in 1 BOTTLE (47781-264-01) 100 tablet 2011-12-30 0000-00-00 No No Current 47781-264-05 47781026405 500 TABLET in 1 BOTTLE (47781-264-05) 500 tablet 2011-12-30 0000-00-00 No No Current