Home NDC 10702-070-01 Oxymorphone Hydrochloride
Product NDC 10702-070
Requested package NDC 10702-070-01
11-digit product format 107020070
Labeler code 10702
Product ID 10702-070_499ffc26-7516-aea3-e063-6394a90a5845
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Oxymorphone Hydrochloride
Dosage form TABLET
Route ORAL
Labeler KVK-Tech, Inc.
Application ANDA203601
Marketing category ANDA
Marketing start 2013-02-11
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 43 .
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 A203601-001 OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-01-30 A203601-002 OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB RS 2013-01-30
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 · 86 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 2026-09-14 22:38:34 2026-08 A203601-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-01-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203601-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB RS 2013-01-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 A203601-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-01-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203601-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB RS 2013-01-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203601-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-01-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203601-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB RS 2013-01-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203601-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-01-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203601-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB RS 2013-01-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203601-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-01-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203601-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB RS 2013-01-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203601-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-01-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203601-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB RS 2013-01-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203601-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-01-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203601-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB RS 2013-01-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203601-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-01-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203601-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB RS 2013-01-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203601-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-01-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203601-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB RS 2013-01-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203601-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-01-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203601-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB RS 2013-01-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203601-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-01-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203601-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB RS 2013-01-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203601-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-01-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203601-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB RS 2013-01-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203601-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-01-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203601-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB RS 2013-01-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203601-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-01-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203601-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB RS 2013-01-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203601-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-01-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203601-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB RS 2013-01-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203601-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-01-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A203601-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB RS 2013-01-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203601-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-01-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203601-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB RS 2013-01-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203601-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-01-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A203601-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB RS 2013-01-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203601-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-01-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A203601-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB RS 2013-01-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203601-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-01-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A203601-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2013-01-30 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 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 10702-070-01 Oxymorphone Hydrochloride 100 in 1 BOTTLE TABLET 100 17 10702-070-06 Oxymorphone Hydrochloride 60 in 1 BOTTLE TABLET 60 17
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded OXYMORPHONE HYDROCHLORIDE ACTIVE INGREDIENT 5Y2EI94NBC OXYMORPHONE HYDROCHLORIDE TABLET [KVK-TECH, INC.] 3 OXYMORPHONE ACTIVE MOIETY 9VXA968E0C OXYMORPHONE HYDROCHLORIDE TABLET [KVK-TECH, INC.] 3 D&C RED NO. 30 INACTIVE INGREDIENT 2S42T2808B OXYMORPHONE HYDROCHLORIDE TABLET [KVK-TECH, INC.] 3 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK OXYMORPHONE HYDROCHLORIDE TABLET [KVK-TECH, INC.] 3 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X OXYMORPHONE HYDROCHLORIDE TABLET [KVK-TECH, INC.] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 OXYMORPHONE HYDROCHLORIDE TABLET [KVK-TECH, INC.] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ OXYMORPHONE HYDROCHLORIDE TABLET [KVK-TECH, INC.] 3 OXYMORPHONE HYDROCHLORIDE ACTIVE INGREDIENT 5Y2EI94NBC OXYMORPHONE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] 1 OXYMORPHONE ACTIVE MOIETY 9VXA968E0C OXYMORPHONE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] 1 D&C RED NO. 30 INACTIVE INGREDIENT 2S42T2808B OXYMORPHONE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK OXYMORPHONE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X OXYMORPHONE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 OXYMORPHONE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ OXYMORPHONE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10702-070 OXYMORPHONE HYDROCHLORIDE TABLET [KVK-TECH, INC.] 15 Current NDC, Legacy NDC, 2 package rows 20240118_dcb5b5d2-7d0a-497a-8f1e-3b96fd43320b.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 10702-070-01 10702007001 100 TABLET in 1 BOTTLE (10702-070-01) 100 tablet 2013-02-11 0000-00-00 No No Current