NDC 54879-003

Dexamethasone

Dexamethasone

Dexamethasone is a Oral Elixir in the Human Prescription Drug category. It is labeled and distributed by Sti Pharma Llc. The primary component is Dexamethasone.

Product ID54879-003_d5792fb0-0c66-696b-e053-2a95a90a806a
NDC54879-003
Product TypeHuman Prescription Drug
Proprietary NameDexamethasone
Generic NameDexamethasone
Dosage FormElixir
Route of AdministrationORAL
Marketing Start Date1976-09-21
Marketing CategoryANDA / ANDA
Application NumberANDA084754
Labeler NameSTI Pharma LLC
Substance NameDEXAMETHASONE
Active Ingredient Strength1 mg/5mL
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 54879-003-08

237 mL in 1 BOTTLE, GLASS (54879-003-08)
Marketing Start Date1976-09-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 54879-003-08 [54879000308]

Dexamethasone ELIXIR
Marketing CategoryANDA
Application NumberANDA084754
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1976-09-21

Drug Details

Active Ingredients

IngredientStrength
DEXAMETHASONE.5 mg/5mL

OpenFDA Data

SPL SET ID:320747b3-5cf1-4e0c-b670-c6a9e72a8845
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 309686

    • Pharmacological Class

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

    Medicade Reported Pricing

    54879000308 DEXAMETHASONE 0.5 MG/5 ML ELX

    Pricing Unit: ML | Drug Type:

    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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