NDC 67253-191

bicalutamide

Bicalutamide

bicalutamide is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Dava Pharmaceuticals, Inc.. The primary component is Bicalutamide.

• Product ID: 67253-191_0353c7a7-53e1-4628-8585-049afbc48c1b
• NDC: 67253-191
• Product Type: Human Prescription Drug
• Proprietary Name: bicalutamide
• Generic Name: Bicalutamide
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2009-07-06
• Marketing Category: ANDA / ANDA
• Application Number: ANDA077973
• Labeler Name: Dava Pharmaceuticals, Inc.
• Substance Name: BICALUTAMIDE
• Active Ingredient Strength: 50 mg/1
• Pharm Classes: Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 67253-191-03

30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (67253-191-03)

• Marketing Start Date: 2009-07-06
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 67253-191-10 [67253019110]

bicalutamide TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA077973
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2009-07-06
• Inactivation Date: 2019-10-21

NDC 67253-191-03 [67253019103]

bicalutamide TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA077973
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2009-07-06
• Inactivation Date: 2019-10-21

Drug Details

Active Ingredients

Ingredient	Strength
BICALUTAMIDE	50 mg/1

OpenFDA Data

• SPL SET ID: 59df7b06-81d0-423c-9e80-9014d424b64c
• Manufacturer:
  • Dava Pharmaceuticals, Inc.
• UNII:
  • A0Z3NAU9DP
• RxNorm Concept Unique ID - RxCUI:
  • 199123
• UPC Code:
  • 0367253191108
  • 0367253191030

Pharmacological Class

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

NDC Crossover Matching brand name "bicalutamide" or generic name "Bicalutamide"

NDC	Brand Name	Generic Name
0093-0220	Bicalutamide	Bicalutamide
0904-6019	Bicalutamide	Bicalutamide
16714-571	Bicalutamide	bicalutamide
16714-816	Bicalutamide	Bicalutamide
16729-023	Bicalutamide	Bicalutamide
47335-485	bicalutamide	bicalutamide
60429-177	Bicalutamide	Bicalutamide
60505-2642	Bicalutamide	Bicalutamide
62559-890	Bicalutamide	Bicalutamide
63629-8308	Bicalutamide	Bicalutamide
63672-0005	Bicalutamide	Bicalutamide
65841-613	Bicalutamide	Bicalutamide
67253-191	bicalutamide	bicalutamide
68382-224	Bicalutamide	Bicalutamide
70518-2993	Bicalutamide	Bicalutamide
71205-577	Bicalutamide	Bicalutamide
71335-0765	Bicalutamide	Bicalutamide
0310-0705	CASODEX	Bicalutamide
62559-680	CASODEX	Bicalutamide