NDC 68842-301

Fulvestrant

Fulvestrant

Fulvestrant is a Intramuscular Injection in the Human Prescription Drug category. It is labeled and distributed by Ebewe Pharma Ges.m.b.h. Nfg.kg. The primary component is Fulvestrant.

Product ID68842-301_bde57084-4e15-45d0-9290-55dd66a56452
NDC68842-301
Product TypeHuman Prescription Drug
Proprietary NameFulvestrant
Generic NameFulvestrant
Dosage FormInjection
Route of AdministrationINTRAMUSCULAR
Marketing Start Date2019-05-29
Marketing CategoryANDA / ANDA
Application NumberANDA205935
Labeler NameEBEWE Pharma Ges.m.b.H. Nfg.KG
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 68842-301-12

2 SYRINGE, GLASS in 1 CARTON (68842-301-12) > 5 mL in 1 SYRINGE, GLASS (68842-301-01)
Marketing Start Date2019-05-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68842-301-01 [68842030101]

Fulvestrant INJECTION
Marketing CategoryANDA
Application NumberANDA205935
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-29

NDC 68842-301-12 [68842030112]

Fulvestrant INJECTION
Marketing CategoryANDA
Application NumberANDA205935
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-29

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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