TERCONAZOLE

Product NDC
0591-3196
11-digit product format
005913196
Labeler code
0591
Product ID
0591-3196_6f162fe6-6443-11e8-9489-6877e1fc7600
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TERCONAZOLE
Dosage form
CREAM
Route
VAGINAL
Labeler
Actavis Pharma, Inc
Application
NDA019579
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2004-04-01
Marketing end
0000-00-00
Substance
TERCONAZOLE
Active strength
4 mg/g
Pharmacologic classes
Azole Antifungal [EPC],Azoles [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a1f2acc3-46a1-8c88-4468-5826c2e9fea6Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-3196-89GM - Gram0591-319675858fd4-1b42-44c9-bb7b-d9926e1486cd12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TERCONAZOLEACTIVE INGREDIENT0KJ2VE664UTERCONAZOLE CREAM [H.J. HARKINS COMPANY, INC.]3
TERCONAZOLEACTIVE MOIETY0KJ2VE664UTERCONAZOLE CREAM [H.J. HARKINS COMPANY, INC.]3
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UTERCONAZOLE CREAM [H.J. HARKINS COMPANY, INC.]3
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNTERCONAZOLE CREAM [H.J. HARKINS COMPANY, INC.]3
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSTERCONAZOLE CREAM [H.J. HARKINS COMPANY, INC.]3
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MTERCONAZOLE CREAM [H.J. HARKINS COMPANY, INC.]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTERCONAZOLE CREAM [H.J. HARKINS COMPANY, INC.]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TERCONAZOLE CREAM [H.J. HARKINS COMPANY, INC.]3
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YTERCONAZOLE CREAM [H.J. HARKINS COMPANY, INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RTERCONAZOLE CREAM [H.J. HARKINS COMPANY, INC.]3

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313226terconazole 0.4 % Vaginal CreamPSN91c8519c-314e-4b30-95a5-aefa3b0338d97
313227terconazole 0.8 % Vaginal CreamPSN91c8519c-314e-4b30-95a5-aefa3b0338d97
313226terconazole 4 MG/ML Vaginal CreamSCD91c8519c-314e-4b30-95a5-aefa3b0338d97
313227terconazole 8 MG/ML Vaginal CreamSCD91c8519c-314e-4b30-95a5-aefa3b0338d97
313226terconazole 0.4 % Vaginal CreamSY91c8519c-314e-4b30-95a5-aefa3b0338d97
313227terconazole 0.8 % Vaginal CreamSY91c8519c-314e-4b30-95a5-aefa3b0338d97
313226terconazole 0.4 % Vaginal CreamPSN426c71b4-39cf-4d12-ad6a-8f64a7c154903
313226terconazole 4 MG/ML Vaginal CreamSCD426c71b4-39cf-4d12-ad6a-8f64a7c154903
313226terconazole 0.4 % Vaginal CreamSY426c71b4-39cf-4d12-ad6a-8f64a7c154903