FDA.reportPublic FDA data

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 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
A204459-001OXYMORPHONE HYDROCHLORIDEOXYMORPHONE HYDROCHLORIDE5MGTABLET / ORALAB2016-04-26
A204459-002OXYMORPHONE HYDROCHLORIDEOXYMORPHONE HYDROCHLORIDE10MGTABLET / ORALAB2016-04-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204459-001AB
A204459-002AB

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 22:54:322026-06A204459-001OXYMORPHONE HYDROCHLORIDE5MGTABLET / ORALAB2016-04-26a50c72e98297…
2026-08-01 22:54:322026-06A204459-002OXYMORPHONE HYDROCHLORIDE10MGTABLET / ORALAB2016-04-26a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A204459-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A204459-002AB1a50c72e98297…

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 HYDROCHLORIDEAurolife Pharma, LLC22c7652a-aa16-4fa8-89d9-517e690590682026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204459
application number: ANDA204459
ndc (product): 13107-104

Additional Listing Data#

Finished product
Yes
Brand name base
Oxymorphone Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYMORPHONE HYDROCHLORIDE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5Y2EI94NBCInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
977939Internal RxNorm lookup
977942Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
22c7652a-aa16-4fa8-89d9-517e69059068Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
52f0f025-f368-4487-8f9b-49af2656aeebProduct name320201015
3792daf4-c308-47ef-a996-98dc7faa1671Product name220150511
0476a93f-c9eb-691e-8ebf-e5b816d8f47bProduct name120140508
a4b9889e-23ea-ee9f-05f6-4b861fda077bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13107-104-01Oxymorphone Hydrochloride100 in 1 BOTTLETABLET10015
13107-104-30Oxymorphone Hydrochloride30 in 1 BOTTLETABLET3015
13107-104-99Oxymorphone Hydrochloride1000 in 1 BOTTLETABLET100015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13107-104-01EA - Each13107-104d54e700c-d36f-4be9-ade7-6c54cfcea36112016-11-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13107-104OXYMORPHONE HYDROCHLORIDE TABLET [AUROLIFE PHARMA, LLC]14Current NDC, Legacy NDC, 3 package rows20240711_22c7652a-aa16-4fa8-89d9-517e69059068.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
977942oxyMORphone HCl 10 MG Oral TabletPSN22c7652a-aa16-4fa8-89d9-517e6905906815
977939oxyMORphone HCl 5 MG Oral TabletPSN22c7652a-aa16-4fa8-89d9-517e6905906815
977942oxymorphone hydrochloride 10 MG Oral TabletSCD22c7652a-aa16-4fa8-89d9-517e6905906815
977939oxymorphone hydrochloride 5 MG Oral TabletSCD22c7652a-aa16-4fa8-89d9-517e6905906815

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13107-104-0113107010401100 TABLET in 1 BOTTLE (13107-104-01) 100 tablet2016-04-260000-00-00NoNoCurrent
13107-104-301310701043030 TABLET in 1 BOTTLE (13107-104-30) 30 tablet2016-04-260000-00-00NoNoCurrent
13107-104-99131070104991000 TABLET in 1 BOTTLE (13107-104-99) 1000 tablet2016-04-260000-00-00NoNoCurrent