NDC 70518-1534

Dexamethasone

Dexamethasone

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

Product ID70518-1534_784e528f-8a7d-2ad0-e053-2991aa0a1086
NDC70518-1534
Product TypeHuman Prescription Drug
Proprietary NameDexamethasone
Generic NameDexamethasone
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-10-15
Marketing CategoryANDA / ANDA
Application NumberANDA084612
Labeler NameREMEDYREPACK INC.
Substance NameDEXAMETHASONE
Active Ingredient Strength4 mg/1
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 70518-1534-0

30 TABLET in 1 BLISTER PACK (70518-1534-0)
Marketing Start Date2018-10-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-1534-0 [70518153400]

Dexamethasone TABLET
Marketing CategoryANDA
Application NumberANDA084612
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-15

NDC 70518-1534-1 [70518153401]

Dexamethasone TABLET
Marketing CategoryANDA
Application NumberANDA084612
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-13

Drug Details

Active Ingredients

IngredientStrength
DEXAMETHASONE4 mg/1

OpenFDA Data

SPL SET ID:f5c9b70b-b835-4f3b-9643-0aec50a0d3f2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197582
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0054-3177DexamethasoneDexamethasone
    0054-4179DexamethasoneDexamethasone
    0054-4180DexamethasoneDexamethasone
    0054-4181DexamethasoneDexamethasone
    0054-4182DexamethasoneDexamethasone
    0054-4183DexamethasoneDexamethasone
    0054-4184DexamethasoneDexamethasone
    0054-4186DexamethasoneDexamethasone
    0054-8174DexamethasoneDexamethasone
    68071-4127DexamethasoneDexamethasone
    68788-7142DexamethasoneDexamethasone
    68788-7267DexamethasoneDexamethasone
    68788-9939DexamethasoneDexamethasone
    68788-9938DexamethasoneDexamethasone
    0054-8176DexamethasoneDexamethasone
    0054-8181DexamethasoneDexamethasone
    0054-8183DexamethasoneDexamethasone
    0054-8180DexamethasoneDexamethasone
    0054-8175DexamethasoneDexamethasone
    0054-8179DexamethasoneDexamethasone
    70518-0843DexamethasoneDexamethasone
    70518-1534DexamethasoneDexamethasone
    71335-0177DexamethasoneDexamethasone
    71335-0077DexamethasoneDexamethasone
    10544-211DexamethasoneDexamethasone
    10544-212DexamethasoneDexamethasone
    0095-0089DexamethasoneDexamethasone
    0095-0088DexamethasoneDexamethasone
    0095-0087DexamethasoneDexamethasone
    21695-382DexamethasoneDexamethasone
    21695-290DexamethasoneDexamethasone
    21695-728DexamethasoneDexamethasone
    21695-745DexamethasoneDexamethasone
    33261-625DexamethasoneDexamethasone
    42195-151DexamethasoneDexamethasone
    43063-266DexamethasoneDexamethasone
    48102-048DexamethasoneDexamethasone
    48102-047DexamethasoneDexamethasone
    48102-046DexamethasoneDexamethasone
    48102-045DexamethasoneDexamethasone
    49999-059DexamethasoneDexamethasone
    49884-085DexamethasoneDexamethasone
    49884-086DexamethasoneDexamethasone
    49884-087DexamethasoneDexamethasone
    49884-373DexamethasoneDexamethasone
    49884-084DexamethasoneDexamethasone
    50090-0091DexamethasoneDexamethasone
    50090-0090DexamethasoneDexamethasone
    50090-0088DexamethasoneDexamethasone
    50090-0089DexamethasoneDexamethasone

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