NDC 0378-3520

Fosamprenavir Calcium

Fosamprenavir Calcium

Fosamprenavir Calcium 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 Fosamprenavir Calcium.

Product ID0378-3520_1e209ffb-4b81-41fe-b4e6-d6e98fbf59b5
NDC0378-3520
Product TypeHuman Prescription Drug
Proprietary NameFosamprenavir Calcium
Generic NameFosamprenavir Calcium
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2017-09-18
Marketing CategoryANDA / ANDA
Application NumberANDA204060
Labeler NameMylan Pharmaceuticals Inc.
Substance NameFOSAMPRENAVIR CALCIUM
Active Ingredient Strength700 mg/1
Pharm ClassesProtease Inhibitor [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A4 Inducers [MoA],P-Glycoprotein Inducers [MoA],HIV Protease Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0378-3520-91

60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3520-91)
Marketing Start Date2017-09-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-3520-91 [00378352091]

Fosamprenavir Calcium TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA204060
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-09-18

Drug Details

Active Ingredients

IngredientStrength
FOSAMPRENAVIR CALCIUM700 mg/1

OpenFDA Data

SPL SET ID:3a1424d8-844c-4e24-9ebd-b2c2b61b61a3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 402109
  • UPC Code
  • 0303783520919
  • Pharmacological Class

    • Protease Inhibitor [EPC]
    • Cytochrome P450 3A4 Inhibitors [MoA]
    • Cytochrome P450 3A4 Inducers [MoA]
    • P-Glycoprotein Inducers [MoA]
    • HIV Protease Inhibitors [MoA]

    NDC Crossover Matching brand name "Fosamprenavir Calcium" or generic name "Fosamprenavir Calcium"

    NDCBrand NameGeneric Name
    0378-3520Fosamprenavir Calciumfosamprenavir calcium
    63304-583Fosamprenavir CalciumFosamprenavir Calcium
    49702-207LEXIVAfosamprenavir calcium
    49702-208LEXIVAfosamprenavir calcium
    53808-0281LEXIVAfosamprenavir calcium
    53808-1010LEXIVAfosamprenavir calcium

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