NDC 0310-0705

CASODEX

Bicalutamide

CASODEX is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Astrazeneca Pharmaceuticals Lp. The primary component is Bicalutamide.

• Product ID: 0310-0705_dbfb2d98-13ad-4815-83d6-b0e10e184881
• NDC: 0310-0705
• Product Type: Human Prescription Drug
• Proprietary Name: CASODEX
• Generic Name: Bicalutamide
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 1995-10-16
• Marketing End Date: 2019-09-30
• Marketing Category: NDA / NDA
• Application Number: NDA020498
• Labeler Name: AstraZeneca Pharmaceuticals LP
• Substance Name: BICALUTAMIDE
• Active Ingredient Strength: 50 mg/1
• Pharm Classes: Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC]
• NDC Exclude Flag: N

Packaging

NDC 0310-0705-30

30 TABLET in 1 BOTTLE, PLASTIC (0310-0705-30)

• Marketing Start Date: 1995-10-16
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0310-0705-10 [00310070510]

CASODEX TABLET

• Marketing Category: NDA
• Application Number: NDA020498
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1995-10-16
• Marketing End Date: 2013-07-31

NDC 0310-0705-30 [00310070530]

CASODEX TABLET

• Marketing Category: NDA
• Application Number: NDA020498
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1995-10-16
• Marketing End Date: 2019-09-30

NDC 0310-0705-39 [00310070539]

CASODEX TABLET

• Marketing Category: NDA
• Application Number: NDA020498
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1995-10-16
• Marketing End Date: 2013-01-31

Drug Details

Active Ingredients

Ingredient	Strength
BICALUTAMIDE	50 mg/1

OpenFDA Data

• SPL SET ID: 03607c0d-b772-435f-c985-ecce8ea8cafd
• Manufacturer:
  • AstraZeneca Pharmaceuticals LP
• UNII:
  • A0Z3NAU9DP
• RxNorm Concept Unique ID - RxCUI:
  • 199123
  • 108828

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
0310-0705	CASODEX	Bicalutamide
62559-680	CASODEX	Bicalutamide
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