Home NDC 31722-930 OXYMORPHONE HYDROCHLORIDE
Product NDC 31722-930
11-digit product format 317220930
Labeler code 31722
Product ID 31722-930_53da63d9-6ef9-4feb-b704-5b7ef1785f6c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name OXYMORPHONE HYDROCHLORIDE
Dosage form TABLET
Route ORAL
Labeler Camber Pharmaceuticals, Inc
Application ANDA210175
Marketing category ANDA
Marketing start 2018-03-01
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 A210175-001 OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2018-02-02 A210175-002 OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2018-02-02
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 A210175-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2018-02-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210175-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2018-02-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210175-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2018-02-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210175-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2018-02-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210175-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2018-02-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210175-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2018-02-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210175-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2018-02-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210175-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2018-02-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210175-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2018-02-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210175-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2018-02-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210175-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2018-02-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210175-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2018-02-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210175-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2018-02-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210175-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2018-02-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210175-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2018-02-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210175-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2018-02-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210175-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2018-02-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210175-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2018-02-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210175-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2018-02-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A210175-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2018-02-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210175-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2018-02-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210175-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2018-02-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210175-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2018-02-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210175-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2018-02-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210175-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2018-02-02 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210175-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2018-02-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210175-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2018-02-02 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A210175-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2018-02-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210175-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2018-02-02 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210175-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2018-02-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210175-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2018-02-02 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A210175-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2018-02-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210175-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2018-02-02 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A210175-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2018-02-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A210175-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2018-02-02 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A210175-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2018-02-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A210175-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2018-02-02 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A210175-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2018-02-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210175-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2018-02-02 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A210175-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2018-02-02 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 31722-930-01 OXYMORPHONE HYDROCHLORIDE 100 in 1 BOTTLE TABLET 100 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 31722-930 OXYMORPHONE HYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS, INC] 6 Current NDC, Legacy NDC, 1 package rows 20240418_06af7dff-c261-4c03-9cd9-0605c42507fa.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 · 3 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE Camber Pharmaceuticals, Inc 06af7dff-c261-4c03-9cd9-0605c42507fa 2025-08-18 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 210175 application number: ANDA210175 ndc (product): 31722-930 OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE Bryant Ranch Prepack 560e9425-dfcb-4fb4-a759-b1e3f8f40fdb 2024-01-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 210175 application number: ANDA210175 OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE XLCare Pharmaceuticals, Inc. 1a1d5061-b62a-49fa-a5b2-4970f51416ae 2020-05-07 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 210175 application number: ANDA210175
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 31722-930-01 31722093001 100 TABLET in 1 BOTTLE (31722-930-01) 100 tablet 2018-03-01 0000-00-00 No No Current