Home NDC 0054-0283-25 Oxymorphone Hydrochloride
Product NDC 0054-0283
Requested package NDC 0054-0283-25
11-digit product format 000540283
Labeler code 0054
Product ID 0054-0283_8a79e4ba-019b-487c-8171-cdd021b7b986
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 5 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 45 .
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 · 90 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 2026-11-14 07:37:17 2026-10 A090964-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2010-09-27 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A090964-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2010-09-27 d4dbc9d85df4…2026-10-15 13:18:30 2026-09 A090964-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2010-09-27 c2088c7a36db…2026-10-15 13:18:30 2026-09 A090964-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2010-09-27 c2088c7a36db…2026-09-14 22:38:34 2026-08 A090964-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2010-09-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090964-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2010-09-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 A090964-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2010-09-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090964-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2010-09-27 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 90 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Oxymorphone Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OXYMORPHONE 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 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 0054-0283-25 Oxymorphone Hydrochloride 100 in 1 BOTTLE TABLET 100 18
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0054-0283 OXYMORPHONE HYDROCHLORIDE TABLET [HIKMA PHARMACEUTICALS USA INC.] 15 Current NDC, Legacy NDC, 1 package rows 20240203_3eb971cf-ab82-49f3-a46c-4d76a8ce599e.zip
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 0054-0283-25 00054028325 100 TABLET in 1 BOTTLE (0054-0283-25) 100 tablet 2010-09-27 0000-00-00 No No Current