NDC 53002-8130

Terconazole

Terconazole

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

• Product ID: 53002-8130_2d3f4a33-71aa-43e0-b0c9-54e6f513f27f
• NDC: 53002-8130
• Product Type: Human Prescription Drug
• Proprietary Name: Terconazole
• Generic Name: Terconazole
• Dosage Form: Cream
• Route of Administration: VAGINAL
• Marketing Start Date: 2005-01-19
• Marketing Category: ANDA / ANDA
• Application Number: ANDA076043
• Labeler Name: RPK Pharmaceuticals, Inc.
• Substance Name: TERCONAZOLE
• Active Ingredient Strength: 4 mg/g
• Pharm Classes: Azole Antifungal [EPC],Azoles [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 53002-8130-1

1 TUBE, WITH APPLICATOR in 1 CARTON (53002-8130-1) > 45 g in 1 TUBE, WITH APPLICATOR

• Marketing Start Date: 2018-10-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 53002-8130-1 [53002813001]

Terconazole CREAM

• Marketing Category: ANDA
• Application Number: ANDA076043
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-10-01
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
TERCONAZOLE	4 mg/g

OpenFDA Data

• SPL SET ID: 77271d50-de82-4345-a003-e383e8e6576b
• Manufacturer:
  • RPK Pharmaceuticals, Inc.
• UNII:
  • 0KJ2VE664U
• RxNorm Concept Unique ID - RxCUI:
  • 313226

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