Home NDC 42806-331 Oxymorphone Hydrochloride
Product NDC 42806-331
11-digit product format 428060331
Labeler code 42806
Product ID 42806-331_8a01b8b5-5114-46e2-9949-1ab6beb78d81
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Oxymorphone Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Epic Pharma, LLC
Application ANDA201187
Marketing category ANDA
Marketing start 2019-05-15
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 A201187-001 OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2014-12-15 A201187-002 OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2014-12-15
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 2 · 60 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 2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201187-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2014-12-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201187-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2014-12-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201187-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2014-12-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201187-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2014-12-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A201187-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2014-12-15 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A201187-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2014-12-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201187-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2014-12-15 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201187-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2014-12-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A201187-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2014-12-15 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A201187-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2014-12-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A201187-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2014-12-15 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A201187-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2014-12-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A201187-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2014-12-15 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A201187-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2014-12-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A201187-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2014-12-15 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A201187-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2014-12-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A201187-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2014-12-15 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A201187-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2014-12-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A201187-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2014-12-15 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A201187-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2014-12-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A201187-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2014-12-15 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 A201187-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2014-12-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A201187-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2014-12-15 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 A201187-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2014-12-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A201187-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2014-12-15 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 A201187-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2014-12-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A201187-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2014-12-15 3f01610625f2…2019-12-14 00:12 UTC 2019-12 A201187-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2014-12-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A201187-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2014-12-15 b00525d2431f…2019-09-15 20:21 UTC 2019-09 A201187-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2014-12-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A201187-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2014-12-15 ea99ee380514…2019-07-19 19:46 UTC 2019-07 A201187-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2014-12-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A201187-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2014-12-15 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A201187-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2014-12-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A201187-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2014-12-15 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A201187-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2014-12-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A201187-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2014-12-15 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A201187-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2014-12-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A201187-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2014-12-15 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A201187-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2014-12-15 a72a2bbeb626…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 60 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 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42806-331-01 Oxymorphone Hydrochloride 100 in 1 BOTTLE TABLET 100 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42806-331 OXYMORPHONE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC] 10 Current NDC, Legacy NDC, 1 package rows 20241222_95804e72-232d-425d-b23d-a66f43bdf0c6.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 42806-331-01 42806033101 100 TABLET in 1 BOTTLE (42806-331-01) 100 tablet 2019-05-15 0000-00-00 No No Current