Home NDC 13107-104 Oxymorphone Hydrochloride
Product NDC 13107-104
11-digit product format 131070104
Labeler code 13107
Product ID 13107-104_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 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 42 .
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 · 84 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 A204459-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2016-04-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204459-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2016-04-26 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
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 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 13107-104-01 Oxymorphone Hydrochloride 100 in 1 BOTTLE TABLET 100 15 13107-104-30 Oxymorphone Hydrochloride 30 in 1 BOTTLE TABLET 30 15 13107-104-99 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 13107-104 OXYMORPHONE HYDROCHLORIDE TABLET [AUROLIFE PHARMA, LLC] 14 Current NDC, Legacy NDC, 3 package rows 20240711_22c7652a-aa16-4fa8-89d9-517e69059068.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 13107-104-01 13107010401 100 TABLET in 1 BOTTLE (13107-104-01) 100 tablet 2016-04-26 0000-00-00 No No Current 13107-104-30 13107010430 30 TABLET in 1 BOTTLE (13107-104-30) 30 tablet 2016-04-26 0000-00-00 No No Current 13107-104-99 13107010499 1000 TABLET in 1 BOTTLE (13107-104-99) 1000 tablet 2016-04-26 0000-00-00 No No Current