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 ID71288-555_25b69c6b-389a-4d5c-b152-0af50efc12f0
NDC71288-555
Product TypeHuman Prescription Drug
Proprietary NameFulvestrant
Generic NameFulvestrant
Dosage FormInjection
Route of AdministrationINTRAMUSCULAR
Marketing Start Date2019-11-21
Marketing CategoryANDA / ANDA
Application NumberANDA209714
Labeler NameMeitheal Pharmaceuticals Inc
Substance NameFULVESTRANT
Active Ingredient Strength50 mg/mL
Pharm ClassesEstrogen Receptor Antagonist [EPC],Estrogen Receptor Antagonists [MoA],Selective Estrogen Receptor Modulators [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 71288-555-86

2 SYRINGE in 1 CARTON (71288-555-86) > 5 mL in 1 SYRINGE (71288-555-85)
Marketing Start Date2019-11-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71288-555-85 [71288055585]

Fulvestrant INJECTION
Marketing CategoryANDA
Application NumberANDA209714
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-11-21

NDC 71288-555-86 [71288055586]

Fulvestrant INJECTION
Marketing CategoryANDA
Application NumberANDA209714
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-11-21

Drug Details

Active Ingredients

IngredientStrength
FULVESTRANT50 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"

NDCBrand NameGeneric Name
0143-9022FulvestrantFulvestrant
0310-7720FulvestrantFulvestrant
0591-5019FulvestrantFulvestrant
0781-3079FulvestrantFulvestrant
0781-3492FulvestrantFulvestrant
16714-070FULVESTRANTfulvestrant
16714-118FulvestrantFulvestrant
16729-436FULVESTRANTFulvestrant
25021-462fulvestrantfulvestrant
43598-262FulvestrantFulvestrant
70121-1463FulvestrantFulvestrant
63323-715FulvestrantFulvestrant
67457-311FulvestrantFulvestrant
68462-317FulvestrantFulvestrant
70534-002fulvestrantfulvestrant
68001-424fulvestrantfulvestrant
68842-301FulvestrantFulvestrant
70860-211FulvestrantFulvestrant
71288-555FulvestrantFulvestrant
71731-6121FulvestrantFulvestrant
72603-105FulvestrantFulvestrant
0310-0720FASLODEXFulvestrant

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