OXYMORPHONE HYDROCHLORIDE

Product NDC
63629-1926
11-digit product format
636291926
Labeler code
63629
Product ID
63629-1926_c58a9e13-1792-4569-a677-28d9aaf0c9f0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OXYMORPHONE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA210175
Marketing category
ANDA
Marketing start
2018-03-01
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

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
63629-1926-1OXYMORPHONE HYDROCHLORIDE100 in 1 BOTTLETABLET100102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1926-1EA - Each63629-1926650c7df6-ef2f-465c-b1c5-8321ee40302412021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1926OXYMORPHONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 1 package rows20240110_560e9425-dfcb-4fb4-a759-b1e3f8f40fdb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
977939oxyMORphone HCl 5 MG Oral TabletPSN560e9425-dfcb-4fb4-a759-b1e3f8f40fdb102
977939oxymorphone hydrochloride 5 MG Oral TabletSCD560e9425-dfcb-4fb4-a759-b1e3f8f40fdb102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1926-163629192601100 TABLET in 1 BOTTLE (63629-1926-1) 100 tablet2021-01-140000-00-00NoNoCurrent