FDA.reportPublic FDA data

Oxymorphone Hydrochloride

Product NDC
35356-968
Requested package NDC
35356-968-01
11-digit product format
353560968
Labeler code
35356
Product ID
35356-968_a6d134e4-52fd-42f2-8740-20332fb3b614
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxymorphone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Lake Erie Medical DBA Quality Care Products LLC
Application
ANDA203601
Marketing category
ANDA
Marketing start
2013-02-11
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage35356-96835356-968-01DDiscontinued by firm2026-07-31

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203601-001OXYMORPHONE HYDROCHLORIDEOXYMORPHONE HYDROCHLORIDE5MGTABLET / ORALAB2013-01-30
A203601-002OXYMORPHONE HYDROCHLORIDEOXYMORPHONE HYDROCHLORIDE10MGTABLET / ORALABRS2013-01-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A203601-001AB
A203601-002AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A203601-001OXYMORPHONE HYDROCHLORIDE5MGTABLET / ORALAB2013-01-30a50c72e98297…
2026-08-01 22:54:322026-06A203601-002OXYMORPHONE HYDROCHLORIDE10MGTABLET / ORALABRS2013-01-30a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A203601-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A203601-002AB1a50c72e98297…

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oxymorphone HydrochlorideOXYMORPHONE HYDROCHLORIDEKVK-Tech, Inc.dcb5b5d2-7d0a-497a-8f1e-3b96fd43320b2026-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203601
application number: ANDA203601

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
35356-968-012022-08-29C16284748780-1d6a99b39-ccc0-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use Oxymorphone Hydrochloride safely and effectively. see full prescribing information for Oxymorphone Hydrochloride. Oxymorphone Hydrochloride (Oxymorphone Hydrochloride) TABLET for ORAL use. Initial U.S. Approval: 1959
35356-968-302022-08-29C16284748780-1d6a99b39-ccc0-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use Oxymorphone Hydrochloride safely and effectively. see full prescribing information for Oxymorphone Hydrochloride. Oxymorphone Hydrochloride (Oxymorphone Hydrochloride) TABLET for ORAL use. Initial U.S. Approval: 1959
35356-968-602022-08-29C16284748780-1d6a99b39-ccc0-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use Oxymorphone Hydrochloride safely and effectively. see full prescribing information for Oxymorphone Hydrochloride. Oxymorphone Hydrochloride (Oxymorphone Hydrochloride) TABLET for ORAL use. Initial U.S. Approval: 1959
35356-968-012022-01-28C16284748780-1d6a99b39-ccc0-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use Oxymorphone Hydrochloride safely and effectively. see full prescribing information for Oxymorphone Hydrochloride. Oxymorphone Hydrochloride (Oxymorphone Hydrochloride) TABLET for ORAL use. Initial U.S. Approval: 1959
35356-968-302022-01-28C16284748780-1d6a99b39-ccc0-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use Oxymorphone Hydrochloride safely and effectively. see full prescribing information for Oxymorphone Hydrochloride. Oxymorphone Hydrochloride (Oxymorphone Hydrochloride) TABLET for ORAL use. Initial U.S. Approval: 1959
35356-968-602022-01-28C16284748780-1d6a99b39-ccc0-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use Oxymorphone Hydrochloride safely and effectively. see full prescribing information for Oxymorphone Hydrochloride. Oxymorphone Hydrochloride (Oxymorphone Hydrochloride) TABLET for ORAL use. Initial U.S. Approval: 1959

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
35356-968-01EA - Each35356-968d50a0502-c602-4e86-af8d-555eec884cf012016-10-06
35356-968-30EA - Each35356-9684222e874-1ae9-4a43-9738-9a4bb5f03cd612013-11-04
35356-968-60EA - Each35356-968fc1febd4-ff95-4015-a837-b4af2c83e77612016-10-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYMORPHONE HYDROCHLORIDEACTIVE INGREDIENT5Y2EI94NBCOXYMORPHONE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
OXYMORPHONEACTIVE MOIETY9VXA968E0COXYMORPHONE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BOXYMORPHONE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKOXYMORPHONE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XOXYMORPHONE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OXYMORPHONE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOXYMORPHONE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35356-968-0135356096801120 TABLET in 1 BOTTLE (35356-968-01) 120 tablet2013-02-110000-00-00NoNoCurrent