NDC 63187-561

Dexamethasone

Dexamethasone

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

Product ID63187-561_1b3b2d99-0a73-493e-89c1-362cf6f1b0cf
NDC63187-561
Product TypeHuman Prescription Drug
Proprietary NameDexamethasone
Generic NameDexamethasone
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date1978-07-19
Marketing CategoryANDA / ANDA
Application NumberANDA084612
Labeler NameProficient Rx LP
Substance NameDEXAMETHASONE
Active Ingredient Strength4 mg/1
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 63187-561-00

100 TABLET in 1 BOTTLE, PLASTIC (63187-561-00)
Marketing Start Date2015-10-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63187-561-30 [63187056130]

Dexamethasone TABLET
Marketing CategoryANDA
Application NumberANDA084612
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-10-01

NDC 63187-561-15 [63187056115]

Dexamethasone TABLET
Marketing CategoryANDA
Application NumberANDA084612
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-09-01

NDC 63187-561-10 [63187056110]

Dexamethasone TABLET
Marketing CategoryANDA
Application NumberANDA084612
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-10-03

NDC 63187-561-24 [63187056124]

Dexamethasone TABLET
Marketing CategoryANDA
Application NumberANDA084612
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-10-01

NDC 63187-561-90 [63187056190]

Dexamethasone TABLET
Marketing CategoryANDA
Application NumberANDA084612
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-10-01

NDC 63187-561-60 [63187056160]

Dexamethasone TABLET
Marketing CategoryANDA
Application NumberANDA084612
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-10-01

NDC 63187-561-00 [63187056100]

Dexamethasone TABLET
Marketing CategoryANDA
Application NumberANDA084612
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-10-01

Drug Details

Active Ingredients

IngredientStrength
DEXAMETHASONE4 mg/1

OpenFDA Data

SPL SET ID:99296e80-3ca6-4430-9ef7-adca357c31b3
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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