Home NDC 43386-430 Oxycodone Hydrochloride
Product NDC 43386-430
11-digit product format 433860430
Labeler code 43386
Product ID 43386-430_78c8a4dc-d475-41ca-acf7-9078e9c36c7f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Oxycodone Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Lupin Pharmaceuticals,Inc.
Application ANDA204021
Marketing category ANDA
Marketing start 2017-06-12
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 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 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A204021-001 OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL 2017-06-12 A204021-002 OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 10MG TABLET / ORAL 2017-06-12 A204021-003 OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL 2017-06-12 A204021-004 OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 20MG TABLET / ORAL 2017-06-12 A204021-005 OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL 2017-06-12
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 6 · 210 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 A204021-001 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL 2017-06-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204021-002 OXYCODONE HYDROCHLORIDE 10MG TABLET / ORAL 2017-06-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204021-003 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL 2017-06-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204021-004 OXYCODONE HYDROCHLORIDE 20MG TABLET / ORAL 2017-06-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204021-005 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL 2017-06-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204021-001 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL 2017-06-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204021-002 OXYCODONE HYDROCHLORIDE 10MG TABLET / ORAL 2017-06-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204021-003 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL 2017-06-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204021-004 OXYCODONE HYDROCHLORIDE 20MG TABLET / ORAL 2017-06-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204021-005 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL 2017-06-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204021-001 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL 2017-06-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204021-002 OXYCODONE HYDROCHLORIDE 10MG TABLET / ORAL 2017-06-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204021-003 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL 2017-06-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204021-004 OXYCODONE HYDROCHLORIDE 20MG TABLET / ORAL 2017-06-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204021-005 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL 2017-06-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204021-001 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL 2017-06-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204021-002 OXYCODONE HYDROCHLORIDE 10MG TABLET / ORAL 2017-06-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204021-003 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL 2017-06-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204021-004 OXYCODONE HYDROCHLORIDE 20MG TABLET / ORAL 2017-06-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204021-005 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL 2017-06-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204021-001 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL 2017-06-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204021-002 OXYCODONE HYDROCHLORIDE 10MG TABLET / ORAL 2017-06-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204021-003 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL 2017-06-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204021-004 OXYCODONE HYDROCHLORIDE 20MG TABLET / ORAL 2017-06-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204021-005 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL 2017-06-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204021-001 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2017-06-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204021-002 OXYCODONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2017-06-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204021-003 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2017-06-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204021-004 OXYCODONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2017-06-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204021-005 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2017-06-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204021-001 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2017-06-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204021-002 OXYCODONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2017-06-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204021-003 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2017-06-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204021-004 OXYCODONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2017-06-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204021-005 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2017-06-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204021-001 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2017-06-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204021-002 OXYCODONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2017-06-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204021-003 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2017-06-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204021-004 OXYCODONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2017-06-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204021-005 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2017-06-12 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 180 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 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 · 5 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1049611 Internal RxNorm lookup 1049618 Internal RxNorm lookup 1049621 Internal RxNorm lookup 1049683 Internal RxNorm lookup 1049686 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 43386-430-01 Oxycodone Hydrochloride 100 in 1 BOTTLE TABLET 100 5 43386-430-03 Oxycodone Hydrochloride 30 in 1 BOTTLE TABLET 30 5 43386-430-05 Oxycodone Hydrochloride 500 in 1 BOTTLE TABLET 500 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43386-430 OXYCODONE HYDROCHLORIDE TABLET [LUPIN PHARMACEUTICALS,INC.] 5 Current NDC, Legacy NDC, 3 package rows 20240131_801cb437-c189-44f5-83eb-a51c365d8a6b.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 43386-430-01 43386043001 100 TABLET in 1 BOTTLE (43386-430-01) 100 tablet 2017-06-12 0000-00-00 No No Current 43386-430-03 43386043003 30 TABLET in 1 BOTTLE (43386-430-03) 30 tablet 2017-06-12 0000-00-00 No No Current 43386-430-05 43386043005 500 TABLET in 1 BOTTLE (43386-430-05) 500 tablet 2017-06-12 0000-00-00 No No Current