NDC 67457-311

Fulvestrant

Fulvestrant

Fulvestrant is a Intramuscular Injection in the Human Prescription Drug category. It is labeled and distributed by Mylan Institutional Llc. The primary component is Fulvestrant.

• Product ID: 67457-311_4b3d0541-a8f2-4cfc-a0d1-b9c8b6717101
• NDC: 67457-311
• Product Type: Human Prescription Drug
• Proprietary Name: Fulvestrant
• Generic Name: Fulvestrant
• Dosage Form: Injection
• Route of Administration: INTRAMUSCULAR
• Marketing Start Date: 2019-09-09
• Marketing Category: ANDA / ANDA
• Application Number: ANDA208811
• Labeler Name: Mylan Institutional LLC
• 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: 2021-12-31

Packaging

NDC 67457-311-05

2 SYRINGE, GLASS in 1 CARTON (67457-311-05) > 5 mL in 1 SYRINGE, GLASS (67457-311-00)

• Marketing Start Date: 2019-09-09
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 67457-311-05 [67457031105]

Fulvestrant INJECTION

• Marketing Category: ANDA
• Application Number: ANDA208811
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-09-09

NDC 67457-311-00 [67457031100]

Fulvestrant INJECTION

• Marketing Category: ANDA
• Application Number: ANDA208811
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-09-09

Drug Details

Active Ingredients

Ingredient	Strength
FULVESTRANT	50 mg/mL

OpenFDA Data

• SPL SET ID: 6e61139b-da59-4159-8139-2e7351a50690
• Manufacturer:
  • Mylan Institutional LLC
• UNII:
  • 22X328QOC4
• RxNorm Concept Unique ID - RxCUI:
  • 727762

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
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
70121-1463	Fulvestrant	Fulvestrant
63323-715	Fulvestrant	Fulvestrant
67457-311	Fulvestrant	Fulvestrant
68462-317	Fulvestrant	Fulvestrant
70534-002	fulvestrant	fulvestrant
68001-424	fulvestrant	fulvestrant
68842-301	Fulvestrant	Fulvestrant
70860-211	Fulvestrant	Fulvestrant
71288-555	Fulvestrant	Fulvestrant
71731-6121	Fulvestrant	Fulvestrant
72603-105	Fulvestrant	Fulvestrant
0310-0720	FASLODEX	Fulvestrant