TERCONAZOLE

Product NDC: 0591-3197
11-digit product format: 005913197
Labeler code: 0591
Product ID: 0591-3197_6f162fe6-6443-11e8-9489-6877e1fc7600
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: TERCONAZOLE
Dosage form: CREAM
Route: VAGINAL
Labeler: Actavis Pharma, Inc
Application: NDA019964
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2004-04-01
Marketing end: 0000-00-00
Substance: TERCONAZOLE
Active strength: 8 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 concept	Relation	Version	Effective
a1f2acc3-46a1-8c88-4468-5826c2e9fea6	Product name	1	20140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0591-3197-52	GM - Gram	0591-3197	6f0e3b2d-c18b-44ac-a8d4-3b79603a3231	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TERCONAZOLE	ACTIVE INGREDIENT	0KJ2VE664U	TERCONAZOLE CREAM [REBEL DISTRIBUTORS CORP]	1
TERCONAZOLE	ACTIVE INGREDIENT	0KJ2VE664U	TERCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.]	1
TERCONAZOLE	ACTIVE MOIETY	0KJ2VE664U	TERCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.]	1
TERCONAZOLE	ACTIVE MOIETY	0KJ2VE664U	TERCONAZOLE CREAM [REBEL DISTRIBUTORS CORP]	1
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	TERCONAZOLE CREAM [REBEL DISTRIBUTORS CORP]	1
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	TERCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.]	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	TERCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.]	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	TERCONAZOLE CREAM [REBEL DISTRIBUTORS CORP]	1
ISOPROPYL MYRISTATE	INACTIVE INGREDIENT	0RE8K4LNJS	TERCONAZOLE CREAM [REBEL DISTRIBUTORS CORP]	1
ISOPROPYL MYRISTATE	INACTIVE INGREDIENT	0RE8K4LNJS	TERCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.]	1
POLYSORBATE 60	INACTIVE INGREDIENT	CAL22UVI4M	TERCONAZOLE CREAM [REBEL DISTRIBUTORS CORP]	1
POLYSORBATE 60	INACTIVE INGREDIENT	CAL22UVI4M	TERCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	TERCONAZOLE CREAM [REBEL DISTRIBUTORS CORP]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	TERCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	TERCONAZOLE CREAM [REBEL DISTRIBUTORS CORP]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	TERCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.]	1
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	TERCONAZOLE CREAM [REBEL DISTRIBUTORS CORP]	1
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	TERCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	TERCONAZOLE CREAM [REBEL DISTRIBUTORS CORP]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	TERCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.]	1

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0KJ2VE664U	TERCONAZOLE	67915-31-5	TERCONAZOLE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
313226	terconazole 0.4 % Vaginal Cream	PSN	91c8519c-314e-4b30-95a5-aefa3b0338d9	7
313227	terconazole 0.8 % Vaginal Cream	PSN	91c8519c-314e-4b30-95a5-aefa3b0338d9	7
313226	terconazole 4 MG/ML Vaginal Cream	SCD	91c8519c-314e-4b30-95a5-aefa3b0338d9	7
313227	terconazole 8 MG/ML Vaginal Cream	SCD	91c8519c-314e-4b30-95a5-aefa3b0338d9	7
313226	terconazole 0.4 % Vaginal Cream	SY	91c8519c-314e-4b30-95a5-aefa3b0338d9	7
313227	terconazole 0.8 % Vaginal Cream	SY	91c8519c-314e-4b30-95a5-aefa3b0338d9	7
313227	terconazole 0.8 % Vaginal Cream	PSN	472e7b07-83fc-4857-9cc0-50e6aa03f10d	1
313227	terconazole 0.8 % Vaginal Cream	PSN	8e125228-4963-4a7b-a0e7-857e63496486	1
313227	terconazole 8 MG/ML Vaginal Cream	SCD	472e7b07-83fc-4857-9cc0-50e6aa03f10d	1
313227	terconazole 8 MG/ML Vaginal Cream	SCD	8e125228-4963-4a7b-a0e7-857e63496486	1
313227	terconazole 0.8 % Vaginal Cream	SY	472e7b07-83fc-4857-9cc0-50e6aa03f10d	1
313227	terconazole 0.8 % Vaginal Cream	SY	8e125228-4963-4a7b-a0e7-857e63496486	1

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TERCONAZOLE VAGINAL CREAM 0.4% 7-DAY REGIMEN TERCONAZOLE VAGINAL CREAM 0.8% 3-DAY REGIMEN	A-S Medication Solutions	2017-12-15	HUMAN PRESCRIPTION DRUG LABEL	7
TERCONAZOLE VAGINAL CREAM 0.4% 7-Day Regimen TERCONAZOLE VAGINAL CREAM 0.8% 3-Day Regimen	Dispensing Solutions, Inc.	2011-09-22	HUMAN PRESCRIPTION DRUG LABEL	1
TERCONAZOLE VAGINAL CREAM 0.8% 3-Day Regimen	Rebel Distributors Corp	2011-04-28	HUMAN PRESCRIPTION DRUG LABEL	1

TERCONAZOLE

DailyMed Product Concepts#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Related DailyMed Labels#