NDC 0591-5019

Fulvestrant

Fulvestrant

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

Product ID0591-5019_48c91dd6-7190-4d9a-b83e-a10ecb43ed6f
NDC0591-5019
Product TypeHuman Prescription Drug
Proprietary NameFulvestrant
Generic NameFulvestrant
Dosage FormInjection
Route of AdministrationINTRAMUSCULAR
Marketing Start Date2019-08-22
Marketing CategoryNDA / NDA
Application NumberNDA210063
Labeler NameActavis Pharma, Inc.
Substance NameFULVESTRANT
Active Ingredient Strength250 mg/5mL
Pharm ClassesEstrogen Receptor Antagonist [EPC],Estrogen Receptor Antagonists [MoA],Selective Estrogen Receptor Modulators [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0591-5019-02

2 SYRINGE, GLASS in 1 CARTON (0591-5019-02) > 5 mL in 1 SYRINGE, GLASS (0591-5019-11)
Marketing Start Date2019-08-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0591-5019-11 [00591501911]

Fulvestrant INJECTION
Marketing CategoryNDA
Application NumberNDA210063
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-08-22

NDC 0591-5019-02 [00591501902]

Fulvestrant INJECTION
Marketing CategoryNDA
Application NumberNDA210063
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-08-22

Drug Details

Active Ingredients

IngredientStrength
FULVESTRANT250 mg/5mL

Pharmacological Class

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