NDC 55045-3259

TERCONAZOLE

Terconazole

TERCONAZOLE is a Vaginal Cream in the Human Prescription Drug category. It is labeled and distributed by Dispensing Solutions, Inc.. The primary component is Terconazole.

• Product ID: 55045-3259_bce76198-3fdc-482e-8c03-31fd4e134aeb
• NDC: 55045-3259
• Product Type: Human Prescription Drug
• Proprietary Name: TERCONAZOLE
• Generic Name: Terconazole
• Dosage Form: Cream
• Route of Administration: VAGINAL
• Marketing Start Date: 2004-04-01
• Marketing Category: NDA / NDA
• Application Number: NDA019964
• Labeler Name: Dispensing Solutions, Inc.
• Substance Name: TERCONAZOLE
• Active Ingredient Strength: 8 mg/g
• Pharm Classes: Azole Antifungal [EPC],Azoles [CS]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 55045-3259-3

20 g in 1 TUBE, WITH APPLICATOR (55045-3259-3)

• Marketing Start Date: 2004-04-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55045-3259-3 [55045325903]

TERCONAZOLE CREAM

• Marketing Category: NDA
• Application Number: NDA019964
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2004-04-01
• Inactivation Date: 2019-10-29

Drug Details

Active Ingredients

Ingredient	Strength
TERCONAZOLE	8 mg/g

OpenFDA Data

• SPL SET ID: 8e125228-4963-4a7b-a0e7-857e63496486
• Manufacturer:
  • Dispensing Solutions, Inc.
• UNII:
  • 0KJ2VE664U
• RxNorm Concept Unique ID - RxCUI:
  • 313227

Pharmacological Class

• Azole Antifungal [EPC]
• Azoles [CS]

NDC Crossover Matching brand name "TERCONAZOLE" or generic name "Terconazole"

NDC	Brand Name	Generic Name
0168-0346	Terconazole	terconazole
0168-0347	Terconazole	terconazole
0591-3196	TERCONAZOLE	TERCONAZOLE
0591-3197	TERCONAZOLE	TERCONAZOLE
0713-0552	Terconazole	Terconazole
21695-844	Terconazole	Terconazole
21695-933	TERCONAZOLE	terconazole
45802-717	Terconazole	Terconazole
50090-0917	Terconazole	Terconazole
50090-1196	Terconazole	Terconazole
50090-2341	TERCONAZOLE	TERCONAZOLE
50090-6266	Terconazole	terconazole
51672-1302	Terconazole	Terconazole
51672-1304	Terconazole	Terconazole
51672-1330	Terconazole	Terconazole
52959-811	TERCONAZOLE	terconazole
53002-7240	Terconazole	Terconazole
53002-8130	Terconazole	Terconazole
55045-3259	TERCONAZOLE	terconazole
63629-8837	Terconazole	terconazole
68071-1626	Terconazole	Terconazole
70518-1185	Terconazole	Terconazole
50458-531	Terazol 3	TERCONAZOLE
50458-536	Terazol 3	TERCONAZOLE
50458-535	Terazol 7	TERCONAZOLE