Home NDC 0054-0284 Oxymorphone Hydrochloride
Product NDC 0054-0284
11-digit product format 000540284
Labeler code 0054
Product ID 0054-0284_74519e3e-078f-42ea-882e-1df0eb0eaaee
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name oxymorphone hydrochloride
Dosage form TABLET
Route ORAL
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA090964
Marketing category ANDA
Marketing start 2010-09-27
Substance OXYMORPHONE HYDROCHLORIDE
Active strength 10 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 1 .
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 A090964-001 OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2010-09-27 A090964-002 OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2010-09-27
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 · 82 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 A090964-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2010-09-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090964-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2010-09-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090964-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2010-09-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090964-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2010-09-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090964-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2010-09-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090964-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2010-09-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090964-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2010-09-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090964-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2010-09-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090964-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2010-09-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090964-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2010-09-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090964-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2010-09-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090964-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2010-09-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090964-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2010-09-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090964-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2010-09-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090964-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2010-09-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090964-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2010-09-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090964-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2010-09-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090964-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2010-09-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090964-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2010-09-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090964-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2010-09-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090964-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2010-09-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090964-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2010-09-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090964-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2010-09-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090964-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2010-09-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090964-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2010-09-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090964-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2010-09-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090964-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2010-09-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A090964-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2010-09-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090964-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2010-09-27 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090964-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2010-09-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090964-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2010-09-27 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A090964-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2010-09-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090964-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2010-09-27 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A090964-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2010-09-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090964-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2010-09-27 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A090964-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2010-09-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090964-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2010-09-27 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A090964-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2010-09-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090964-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2010-09-27 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A090964-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2010-09-27 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Oxymorphone Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OXYMORPHONE HYDROCHLORIDE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5Y2EI94NBC Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 977939 Internal RxNorm lookup 977942 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 0054-0284-25 Oxymorphone Hydrochloride 100 in 1 BOTTLE TABLET 100 18
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded OXYMORPHONE HYDROCHLORIDE ACTIVE INGREDIENT 5Y2EI94NBC OXYMORPHONE HYDROCHLORIDE TABLET [ROXANE LABORATORIES, INC] 3 OXYMORPHONE ACTIVE MOIETY 9VXA968E0C OXYMORPHONE HYDROCHLORIDE TABLET [ROXANE LABORATORIES, INC] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U OXYMORPHONE HYDROCHLORIDE TABLET [ROXANE LABORATORIES, INC] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 OXYMORPHONE HYDROCHLORIDE TABLET [ROXANE LABORATORIES, INC] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ OXYMORPHONE HYDROCHLORIDE TABLET [ROXANE LABORATORIES, INC] 3 OXYMORPHONE HYDROCHLORIDE ACTIVE INGREDIENT 5Y2EI94NBC OXYMORPHONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 1 OXYMORPHONE ACTIVE MOIETY 9VXA968E0C OXYMORPHONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U OXYMORPHONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 OXYMORPHONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ OXYMORPHONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0054-0284 OXYMORPHONE HYDROCHLORIDE TABLET [HIKMA PHARMACEUTICALS USA INC.] 15 Current NDC, Legacy NDC, 1 package rows 20240203_3eb971cf-ab82-49f3-a46c-4d76a8ce599e.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 · 1 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 0054-0284-25 00054028425 100 TABLET in 1 BOTTLE (0054-0284-25) 100 tablet 2010-09-27 0000-00-00 No No Current