OXYMORPHONE HYDROCHLORIDE

Product NDC
31722-930
11-digit product format
317220930
Labeler code
31722
Product ID
31722-930_53da63d9-6ef9-4feb-b704-5b7ef1785f6c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OXYMORPHONE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc
Application
ANDA210175
Marketing category
ANDA
Marketing start
2018-03-01
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYMORPHONE HYDROCHLORIDE10 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
31722-930-01OXYMORPHONE HYDROCHLORIDE100 in 1 BOTTLETABLET1007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-930OXYMORPHONE HYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS, INC]6Current NDC, Legacy NDC, 1 package rows20240418_06af7dff-c261-4c03-9cd9-0605c42507fa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
977942oxyMORphone HCl 10 MG Oral TabletPSN06af7dff-c261-4c03-9cd9-0605c42507fa7
977939oxyMORphone HCl 5 MG Oral TabletPSN06af7dff-c261-4c03-9cd9-0605c42507fa7
977942oxymorphone hydrochloride 10 MG Oral TabletSCD06af7dff-c261-4c03-9cd9-0605c42507fa7
977939oxymorphone hydrochloride 5 MG Oral TabletSCD06af7dff-c261-4c03-9cd9-0605c42507fa7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
31722-930-0131722093001100 TABLET in 1 BOTTLE (31722-930-01) 100 tablet2018-03-010000-00-00NoNoCurrent