NDC 69097-915

FLUTAMIDE

Flutamide

FLUTAMIDE is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Cipla Usa Inc.. The primary component is Flutamide.

• Product ID: 69097-915_b002fcb1-d247-4333-b38a-6b1de5a05a2c
• NDC: 69097-915
• Product Type: Human Prescription Drug
• Proprietary Name: FLUTAMIDE
• Generic Name: Flutamide
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2016-09-21
• Marketing Category: ANDA / ANDA
• Application Number: ANDA075780
• Labeler Name: Cipla USA Inc.
• Substance Name: FLUTAMIDE
• Active Ingredient Strength: 125 mg/1
• Pharm Classes: Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 69097-915-12

500 CAPSULE in 1 BOTTLE (69097-915-12)

• Marketing Start Date: 2016-09-21
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69097-915-91 [69097091591]

FLUTAMIDE CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA075780
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-09-21

NDC 69097-915-12 [69097091512]

FLUTAMIDE CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA075780
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-09-21

Drug Details

Active Ingredients

Ingredient	Strength
FLUTAMIDE	125 mg/1

OpenFDA Data

• SPL SET ID: 328910be-4d0e-4d7b-a062-e3ce0cf793b9
• Manufacturer:
  • Cipla USA Inc.
• UNII:
  • 76W6J0943E
• RxNorm Concept Unique ID - RxCUI:
  • 197726
• UPC Code:
  • 0369097915919
  • 0369097915124

Pharmacological Class

• Androgen Receptor Antagonists [MoA]
• Androgen Receptor Inhibitor [EPC]
• Androgen Receptor Antagonists [MoA]
• Androgen Receptor Inhibitor [EPC]

Medicade Reported Pricing

69097091591 FLUTAMIDE 125 MG CAPSULE

Pricing Unit: EA | Drug Type:

NDC Crossover Matching brand name "FLUTAMIDE" or generic name "Flutamide"

NDC	Brand Name	Generic Name
0591-2466	Flutamide	Flutamide
49884-753	Flutamide	Flutamide
60429-272	Flutamide	Flutamide
69097-915	FLUTAMIDE	FLUTAMIDE
80725-600	Eulexin	Flutamide