NDC 0378-0197

Chlorpropamide

Chlorpropamide

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

Product ID0378-0197_4839ee63-9713-4e1b-847d-84bc384905fd
NDC0378-0197
Product TypeHuman Prescription Drug
Proprietary NameChlorpropamide
Generic NameChlorpropamide
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date1984-06-01
Marketing CategoryANDA / ANDA
Application NumberANDA088549
Labeler NameMylan Pharmaceuticals Inc.
Substance NameCHLORPROPAMIDE
Active Ingredient Strength100 mg/1
Pharm ClassesSulfonylurea [EPC],Sulfonylurea Compounds [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0378-0197-01

100 TABLET in 1 BOTTLE, PLASTIC (0378-0197-01)
Marketing Start Date1984-06-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-0197-05 [00378019705]

Chlorpropamide TABLET
Marketing CategoryANDA
Application NumberANDA088549
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1984-06-01
Marketing End Date2013-12-16

NDC 0378-0197-01 [00378019701]

Chlorpropamide TABLET
Marketing CategoryANDA
Application NumberANDA088549
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1984-06-01
Marketing End Date2019-04-30

Drug Details

Active Ingredients

IngredientStrength
CHLORPROPAMIDE100 mg/1

OpenFDA Data

SPL SET ID:baa54287-8065-da1a-f19e-ce8daf61bd01
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197496
  • 197495

    • Pharmacological Class

    • Sulfonylurea [EPC]
    • Sulfonylurea Compounds [CS]

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

    NDCBrand NameGeneric Name
    0378-0197Chlorpropamidechlorpropamide
    0378-0210Chlorpropamidechlorpropamide
    55289-066Chlorpropamidechlorpropamide
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.