NDC 68047-702

Dexamethasone 1.5 mg

Dexamethasone 1.5 Mg

Dexamethasone 1.5 mg is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Larken Laboratories, Inc.. The primary component is Dexamethasone.

Product ID68047-702_7be555cd-132c-50b5-e053-2a91aa0a91e2
NDC68047-702
Product TypeHuman Prescription Drug
Proprietary NameDexamethasone 1.5 mg
Generic NameDexamethasone 1.5 Mg
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2017-09-01
Marketing CategoryANDA / ANDA
Application NumberANDA201270
Labeler NameLarken Laboratories, Inc.
Substance NameDEXAMETHASONE
Active Ingredient Strength2 mg/1
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 68047-702-21

21 TABLET in 1 DOSE PACK (68047-702-21)
Marketing Start Date2018-08-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68047-702-21 [68047070221]

Dexamethasone 1.5 mg TABLET
Marketing CategoryANDA
Application NumberANDA201270
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-08-08

NDC 68047-702-35 [68047070235]

Dexamethasone 1.5 mg TABLET
Marketing CategoryANDA
Application NumberANDA201270
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-08-08

NDC 68047-702-51 [68047070251]

Dexamethasone 1.5 mg TABLET
Marketing CategoryANDA
Application NumberANDA201270
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-08-08

NDC 68047-702-01 [68047070201]

Dexamethasone 1.5 mg TABLET
Marketing CategoryANDA
Application NumberANDA201270
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-09-01

Drug Details

Active Ingredients

IngredientStrength
DEXAMETHASONE1.5 mg/1

OpenFDA Data

SPL SET ID:fcc75691-974e-4a67-b9d7-64dde72b5595
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197580
  • 759481
  • 846192
  • 759697
  • UPC Code
  • 0368047702012
  • Pharmacological Class

    • Corticosteroid [EPC]
    • Corticosteroid Hormone Receptor Agonists [MoA]

    NDC Crossover Matching brand name "Dexamethasone 1.5 mg" or generic name "Dexamethasone 1.5 Mg"

    NDCBrand NameGeneric Name
    68047-702DexamethasoneDexamethasone 1.5 mg
    70362-702DxevoDexamethasone 1.5 mg
    70362-707DxevoDexamethasone 1.5 mg

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.