NDC 45802-396

gynazole 1

Butoconazole Nitrate

gynazole 1 is a Vaginal Cream in the Human Prescription Drug category. It is labeled and distributed by Padagis Israel Pharmaceuticals Ltd. The primary component is Butoconazole Nitrate.

• Product ID: 45802-396_10d7e03c-eff0-4383-98fd-a7bf88ab95a1
• NDC: 45802-396
• Product Type: Human Prescription Drug
• Proprietary Name: gynazole 1
• Generic Name: Butoconazole Nitrate
• Dosage Form: Cream
• Route of Administration: VAGINAL
• Marketing Start Date: 2015-04-29
• Marketing Category: ANDA / ANDA
• Application Number: ANDA200923
• Labeler Name: Padagis Israel Pharmaceuticals Ltd
• Substance Name: BUTOCONAZOLE NITRATE
• Active Ingredient Strength: 100 mg/5g
• Pharm Classes: Azole Antifungal [EPC],Azoles [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 45802-396-01

1 TUBE, WITH APPLICATOR in 1 CARTON (45802-396-01) > 5.8 g in 1 TUBE, WITH APPLICATOR

• Marketing Start Date: 2015-04-29
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 45802-396-02 [45802039602]

gynazole 1 CREAM

• Marketing Category: ANDA
• Application Number: ANDA200923
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2015-04-29

NDC 45802-396-01 [45802039601]

gynazole 1 CREAM

• Marketing Category: ANDA
• Application Number: ANDA200923
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2015-04-29

Drug Details

Active Ingredients

Ingredient	Strength
BUTOCONAZOLE NITRATE	100 mg/5g

OpenFDA Data

• SPL SET ID: 125d8ede-db38-4eb9-a6be-19208687f36a
• Manufacturer:
  • Perrigo New York Inc
• UNII:
  • 4805237NP5
• RxNorm Concept Unique ID - RxCUI:
  • 890785
  • 890786

Pharmacological Class

• Azole Antifungal [EPC]
• Azoles [CS]
• Azole Antifungal [EPC]
• Azoles [CS]

Medicade Reported Pricing

45802039601 GYNAZOLE 1 2% CREAM

Pricing Unit: GM | Drug Type: