Home NDC 72189-095-30 OXYCODONE HYDROCHLORIDE
Product NDC 72189-095
Requested package NDC 72189-095-30
11-digit product format 721890095
Labeler code 72189
Product ID 72189-095_36d68732-0635-1380-e063-6394a90a69c6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name OXYCODONE HYDROCHLORIDE
Dosage form TABLET
Route ORAL
Labeler DIRECT RX
Application ANDA204021
Marketing category ANDA
Marketing start 2020-06-15
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 7 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
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 5 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1049214 Internal RxNorm lookup 1049225 Internal RxNorm lookup 1049621 Internal RxNorm lookup 1049683 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72189-095-30 OXYCODONE HYDROCHLORIDE 30 in 1 BOTTLE TABLET 30 10 72189-095-60 OXYCODONE HYDROCHLORIDE 60 in 1 BOTTLE TABLET 60 10 72189-095-90 OXYCODONE HYDROCHLORIDE 90 in 1 BOTTLE TABLET 90 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72189-095 OXYCODONE HYDROCHLORIDE TABLET OXYCODONE AND ACETAMINOPHEN TABLET [DIRECT RX] 9 Current NDC, Legacy NDC, 3 package rows 20231025_a8206207-ad09-83df-e053-2995a90a78b7.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 72189-095-30 72189009530 30 TABLET in 1 BOTTLE (72189-095-30) 30 tablet 2020-06-15 0000-00-00 No No Current