FDA.reportPublic FDA data

Oxymorphone Hydrochloride

Product NDC
10702-071
11-digit product format
107020071
Labeler code
10702
Product ID
10702-071_499ffc26-7516-aea3-e063-6394a90a5845
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxymorphone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
KVK-Tech, Inc.
Application
ANDA203601
Marketing category
ANDA
Marketing start
2013-02-11
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
2027-12-31
Current FDA listing
Yes

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 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
10702-071-01Oxymorphone Hydrochloride100 in 1 BOTTLETABLET10017
10702-071-06Oxymorphone Hydrochloride60 in 1 BOTTLETABLET6017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10702-071-01EA - Each10702-07187b80e5e-ec76-41c1-abed-4d3398a138db12013-03-03
10702-071-06EA - Each10702-07152e388af-57f0-410f-add4-ba591bf2f65212019-01-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYMORPHONE HYDROCHLORIDEACTIVE INGREDIENT5Y2EI94NBCOXYMORPHONE HYDROCHLORIDE TABLET [KVK-TECH, INC.]3
OXYMORPHONEACTIVE MOIETY9VXA968E0COXYMORPHONE HYDROCHLORIDE TABLET [KVK-TECH, INC.]3
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BOXYMORPHONE HYDROCHLORIDE TABLET [KVK-TECH, INC.]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKOXYMORPHONE HYDROCHLORIDE TABLET [KVK-TECH, INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XOXYMORPHONE HYDROCHLORIDE TABLET [KVK-TECH, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OXYMORPHONE HYDROCHLORIDE TABLET [KVK-TECH, INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOXYMORPHONE HYDROCHLORIDE TABLET [KVK-TECH, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10702-071OXYMORPHONE HYDROCHLORIDE TABLET [KVK-TECH, INC.]15Current NDC, Legacy NDC, 2 package rows20240118_dcb5b5d2-7d0a-497a-8f1e-3b96fd43320b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
977942oxyMORphone HCl 10 MG Oral TabletPSNdcb5b5d2-7d0a-497a-8f1e-3b96fd43320b17
977939oxyMORphone HCl 5 MG Oral TabletPSNdcb5b5d2-7d0a-497a-8f1e-3b96fd43320b17
977942oxymorphone hydrochloride 10 MG Oral TabletSCDdcb5b5d2-7d0a-497a-8f1e-3b96fd43320b17
977939oxymorphone hydrochloride 5 MG Oral TabletSCDdcb5b5d2-7d0a-497a-8f1e-3b96fd43320b17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10702-071-0110702007101100 TABLET in 1 BOTTLE (10702-071-01) 100 tablet2013-02-110000-00-00NoNoCurrent
10702-071-061070200710660 TABLET in 1 BOTTLE (10702-071-06) 60 tablet2018-06-250000-00-00NoNoCurrent