NDC 68001-424

fulvestrant

Fulvestrant

fulvestrant is a Intramuscular Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Bluepoint Laboratories. The primary component is Fulvestrant.

Product ID68001-424_916a5a5e-4d74-4616-8d44-c58d0db649d8
NDC68001-424
Product TypeHuman Prescription Drug
Proprietary Namefulvestrant
Generic NameFulvestrant
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR
Marketing Start Date2019-08-01
Marketing CategoryANDA / ANDA
Application NumberANDA205871
Labeler NameBluePoint Laboratories
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 68001-424-85

2 SYRINGE in 1 CARTON (68001-424-85) > 5 mL in 1 SYRINGE (68001-424-86)
Marketing Start Date2019-12-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68001-424-86 [68001042486]

fulvestrant INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA205871
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-08-01

NDC 68001-424-85 [68001042485]

fulvestrant INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA205871
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-12-10

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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