NDC 71288-555

Fulvestrant

Fulvestrant

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

• Product ID: 71288-555_25b69c6b-389a-4d5c-b152-0af50efc12f0
• NDC: 71288-555
• Product Type: Human Prescription Drug
• Proprietary Name: Fulvestrant
• Generic Name: Fulvestrant
• Dosage Form: Injection
• Route of Administration: INTRAMUSCULAR
• Marketing Start Date: 2019-11-21
• Marketing Category: ANDA / ANDA
• Application Number: ANDA209714
• Labeler Name: Meitheal Pharmaceuticals Inc
• 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 71288-555-86

2 SYRINGE in 1 CARTON (71288-555-86) > 5 mL in 1 SYRINGE (71288-555-85)

• Marketing Start Date: 2019-11-21
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 71288-555-85 [71288055585]

Fulvestrant INJECTION

• Marketing Category: ANDA
• Application Number: ANDA209714
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-11-21

NDC 71288-555-86 [71288055586]

Fulvestrant INJECTION

• Marketing Category: ANDA
• Application Number: ANDA209714
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-11-21

Drug Details

Active Ingredients

Ingredient	Strength
FULVESTRANT	50 mg/mL

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