OXYMORPHONE HYDROCHLORIDE

Product NDC
72865-130
11-digit product format
728650130
Labeler code
72865
Product ID
72865-130_4fdf3b7e-f6ff-4d78-a928-c9d47c5bc9d9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OXYMORPHONE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
XLCare Pharmaceuticals, Inc.
Application
ANDA210175
Marketing category
ANDA
Marketing start
2020-05-06
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
OXYMORPHONE HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYMORPHONE HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5Y2EI94NBC
Rxcui977939, 977942

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
72865-130-01OXYMORPHONE HYDROCHLORIDE100 in 1 BOTTLETABLET1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72865-130-01EA - Each72865-13015b98725-e715-452d-9394-ea306845ec6812020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72865-130OXYMORPHONE HYDROCHLORIDE TABLET [XLCARE PHARMACEUTICALS, INC.]1Current NDC, Legacy NDC, 1 package rows20200508_1a1d5061-b62a-49fa-a5b2-4970f51416ae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
977942oxyMORphone HCl 10 MG Oral TabletPSN1a1d5061-b62a-49fa-a5b2-4970f51416ae1
977939oxyMORphone HCl 5 MG Oral TabletPSN1a1d5061-b62a-49fa-a5b2-4970f51416ae1
977942oxymorphone hydrochloride 10 MG Oral TabletSCD1a1d5061-b62a-49fa-a5b2-4970f51416ae1
977939oxymorphone hydrochloride 5 MG Oral TabletSCD1a1d5061-b62a-49fa-a5b2-4970f51416ae1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72865-130-0172865013001100 TABLET in 1 BOTTLE (72865-130-01) 100 tablet2020-05-060000-00-00NoNoCurrent