NDC 0378-5001

Exemestane

Exemestane

Exemestane is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Exemestane.

Product ID0378-5001_3843631e-c4d0-4454-8af3-8211d490e2af
NDC0378-5001
Product TypeHuman Prescription Drug
Proprietary NameExemestane
Generic NameExemestane
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2017-03-10
Marketing CategoryANDA / ANDA
Application NumberANDA203315
Labeler NameMylan Pharmaceuticals Inc.
Substance NameEXEMESTANE
Active Ingredient Strength25 mg/1
Pharm ClassesAromatase Inhibitor [EPC],Aromatase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0378-5001-93

30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5001-93)
Marketing Start Date2017-03-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-5001-93 [00378500193]

Exemestane TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA203315
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-03-10

Drug Details

Active Ingredients

IngredientStrength
EXEMESTANE25 mg/1

OpenFDA Data

SPL SET ID:3573e3c9-ca05-413f-909f-93607a2ccb79
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310261
  • Pharmacological Class

    • Aromatase Inhibitor [EPC]
    • Aromatase Inhibitors [MoA]
    • Aromatase Inhibitor [EPC]
    • Aromatase Inhibitors [MoA]

    NDC Crossover Matching brand name "Exemestane" or generic name "Exemestane"

    NDCBrand NameGeneric Name
    0054-0080ExemestaneExemestane
    0378-5001Exemestaneexemestane
    0832-0595ExemestaneExemestane
    44278-025ExemestaneEXEMESTANE
    47781-108ExemestaneExemestane
    50090-5193ExemestaneExemestane
    51991-005ExemestaneExemestane
    59651-516ExemestaneExemestane
    59762-2858EXEMESTANEExemestane
    63629-2056ExemestaneExemestane
    65162-240ExemestaneExemestane
    68382-383ExemestaneExemestane
    69097-316EXEMESTANEexemestane
    70771-1374ExemestaneExemestane
    71921-190ExemestaneExemestane
    0009-7663Aromasinexemestane

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