Home NDC 13107-103 Oxymorphone Hydrochloride
Product NDC 13107-103
11-digit product format 131070103
Labeler code 13107
Product ID 13107-103_6c5c7596-0b2c-435f-a619-706b4424370d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Oxymorphone Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Aurolife Pharma, LLC
Application ANDA204459
Marketing category ANDA
Marketing start 2016-04-26
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 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 A204459-001 OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2016-04-26 A204459-002 OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2016-04-26
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 A204459-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2016-04-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204459-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2016-04-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204459-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2016-04-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204459-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2016-04-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204459-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2016-04-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204459-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2016-04-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204459-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2016-04-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204459-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2016-04-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204459-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2016-04-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204459-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2016-04-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204459-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2016-04-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204459-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2016-04-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204459-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2016-04-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204459-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2016-04-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204459-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2016-04-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204459-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2016-04-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204459-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2016-04-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204459-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2016-04-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204459-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2016-04-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204459-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2016-04-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204459-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2016-04-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204459-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2016-04-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204459-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2016-04-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204459-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2016-04-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204459-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2016-04-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204459-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2016-04-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204459-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2016-04-26 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A204459-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2016-04-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204459-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2016-04-26 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204459-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2016-04-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204459-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2016-04-26 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A204459-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2016-04-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204459-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2016-04-26 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A204459-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2016-04-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204459-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2016-04-26 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A204459-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2016-04-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204459-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2016-04-26 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A204459-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2016-04-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204459-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2016-04-26 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A204459-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2016-04-26 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
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 13107-103-01 Oxymorphone Hydrochloride 100 in 1 BOTTLE TABLET 100 15 13107-103-30 Oxymorphone Hydrochloride 30 in 1 BOTTLE TABLET 30 15 13107-103-99 Oxymorphone Hydrochloride 1000 in 1 BOTTLE TABLET 1000 15
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 13107-103 OXYMORPHONE HYDROCHLORIDE TABLET [AUROLIFE PHARMA, LLC] 14 Current NDC, Legacy NDC, 3 package rows 20240711_22c7652a-aa16-4fa8-89d9-517e69059068.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 13107-103-01 13107010301 100 TABLET in 1 BOTTLE (13107-103-01) 100 tablet 2016-04-26 0000-00-00 No No Current 13107-103-30 13107010330 30 TABLET in 1 BOTTLE (13107-103-30) 30 tablet 2016-04-26 0000-00-00 No No Current 13107-103-99 13107010399 1000 TABLET in 1 BOTTLE (13107-103-99) 1000 tablet 2016-04-26 0000-00-00 No No Current