NDC 0310-0720

FASLODEX

Fulvestrant

FASLODEX is a Intramuscular Injection in the Human Prescription Drug category. It is labeled and distributed by Astrazeneca Pharmaceuticals Lp. The primary component is Fulvestrant.

• Product ID: 0310-0720_185e8383-2af3-4ddc-bef9-3ea4351ddbbd
• NDC: 0310-0720
• Product Type: Human Prescription Drug
• Proprietary Name: FASLODEX
• Generic Name: Fulvestrant
• Dosage Form: Injection
• Route of Administration: INTRAMUSCULAR
• Marketing Start Date: 2010-11-01
• Marketing Category: NDA / NDA
• Application Number: NDA021344
• Labeler Name: AstraZeneca Pharmaceuticals LP
• Substance Name: FULVESTRANT
• Active Ingredient Strength: 50 mg/mL
• Pharm Classes: Estrogen Receptor Antagonist [EPC],Estrogen Receptor Antagonists [MoA],Selective Estrogen Receptor Modulators [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 0310-0720-10

2 SYRINGE, GLASS in 1 CARTON (0310-0720-10) > 5 mL in 1 SYRINGE, GLASS

• Marketing Start Date: 2010-11-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0310-0720-10 [00310072010]

FASLODEX INJECTION

• Marketing Category: NDA
• Application Number: NDA021344
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2010-11-01

NDC 0310-0720-50 [00310072050]

FASLODEX INJECTION

• Marketing Category: NDA
• Application Number: NDA021344
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2002-05-20
• Marketing End Date: 2015-10-31

NDC 0310-0720-25 [00310072025]

FASLODEX INJECTION

• Marketing Category: NDA
• Application Number: NDA021344
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2010-11-01
• Marketing End Date: 2010-09-21

Drug Details

Active Ingredients

Ingredient	Strength
FULVESTRANT	50 mg/mL

OpenFDA Data

• SPL SET ID: 83d7a440-e904-4e36-afb5-cb02b1c919f7
• Manufacturer:
  • AstraZeneca Pharmaceuticals LP
• UNII:
  • 22X328QOC4
• RxNorm Concept Unique ID - RxCUI:
  • 727954
  • 727762

Pharmacological Class

• Estrogen Receptor Antagonist [EPC]
• Estrogen Receptor Antagonists [MoA]
• Selective Estrogen Receptor Modulators [MoA]

NDC Crossover Matching brand name "FASLODEX" or generic name "Fulvestrant"

NDC	Brand Name	Generic Name
0310-0720	FASLODEX	Fulvestrant
0143-9022	Fulvestrant	Fulvestrant
0310-7720	Fulvestrant	Fulvestrant
0591-5019	Fulvestrant	Fulvestrant
0781-3079	Fulvestrant	Fulvestrant
0781-3492	Fulvestrant	Fulvestrant
16714-070	FULVESTRANT	fulvestrant
16714-118	Fulvestrant	Fulvestrant
16729-436	FULVESTRANT	Fulvestrant
25021-462	fulvestrant	fulvestrant
43598-262	Fulvestrant	Fulvestrant