NDC 0603-3900

Hydrocortisone

Hydrocortisone

Hydrocortisone is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Par Pharmaceutical. The primary component is Hydrocortisone.

Product ID0603-3900_922778c7-7e86-4fe8-8a5b-5e4d0ad066ab
NDC0603-3900
Product TypeHuman Prescription Drug
Proprietary NameHydrocortisone
Generic NameHydrocortisone
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2007-07-16
Marketing End Date2019-10-31
Marketing CategoryANDA / ANDA
Application NumberANDA040761
Labeler NamePar Pharmaceutical
Substance NameHYDROCORTISONE
Active Ingredient Strength10 mg/1
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN

Packaging

NDC 0603-3900-21

100 TABLET in 1 BOTTLE, PLASTIC (0603-3900-21)
Marketing Start Date2007-07-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0603-3900-32 [00603390032]

Hydrocortisone TABLET
Marketing CategoryANDA
Application NumberANDA040761
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-07-16
Marketing End Date2016-10-26

NDC 0603-3900-28 [00603390028]

Hydrocortisone TABLET
Marketing CategoryANDA
Application NumberANDA040761
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-07-16
Marketing End Date2018-12-04

NDC 0603-3900-10 [00603390010]

Hydrocortisone TABLET
Marketing CategoryANDA
Application NumberANDA040761
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-07-16
Marketing End Date2016-10-26

NDC 0603-3900-21 [00603390021]

Hydrocortisone TABLET
Marketing CategoryANDA
Application NumberANDA040761
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-07-16
Marketing End Date2019-10-31

Drug Details

Active Ingredients

IngredientStrength
HYDROCORTISONE10 mg/1

OpenFDA Data

SPL SET ID:cc6f9187-baa3-46bc-b424-d348be820c50
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197782
  • 197783
  • 197787
    • UPC Code
  • 0306033901216
  • 0306033899216
  • 0306033900219

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0115-1696HYDROCORTISONEhydrocortisone
    0115-1697HYDROCORTISONEhydrocortisone
    0115-1700HYDROCORTISONEhydrocortisone
    0143-1252HydrocortisoneHydrocortisone
    0143-1253HydrocortisoneHydrocortisone
    0143-1254HydrocortisoneHydrocortisone
    0168-0014HYDROCORTISONEHYDROCORTISONE
    0168-0015hydrocortisoneHydrocortisone
    0168-0016HYDROCORTISONEHYDROCORTISONE
    0168-0020HydrocortisoneHydrocortisone
    0168-0080HydrocortisoneHydrocortisone
    0168-0146HydrocortisoneHydrocortisone
    0168-0154HYDROCORTISONEHYDROCORTISONE
    0168-0181HYDROCORTISONEHYDROCORTISONE
    0168-0288Hydrocortisonehydrocortisone
    67777-004HydrocortisoneHydrocortisone
    67777-224HydrocortisoneHydrocortisone
    67777-237HydrocortisoneHydrocortisone
    67777-415HydrocortisoneHydrocortisone
    67777-003HydrocortisoneHydrocortisone
    67777-417HydrocortisoneHydrocortisone
    68071-1844HYDROCORTISONEHYDROCORTISONE
    68071-1581HydrocortisoneHydrocortisone
    68071-4511HydrocortisoneHydrocortisone
    68071-4582HydrocortisoneHydrocortisone
    68084-789HydrocortisoneHydrocortisone
    68084-469HydrocortisoneHydrocortisone
    68151-4021HydrocortisoneHydrocortisone
    68151-2269HYDROCORTISONEHYDROCORTISONE
    68084-930HydrocortisoneHydrocortisone
    0472-0321HydrocortisoneHydrocortisone
    0472-0337HydrocortisoneHydrocortisone
    0498-0800HYDROCORTISONEHYDROCORTISONE
    68599-1182HydrocortisoneHydrocortisone
    68786-223HydrocortisoneHydrocortisone
    68786-224HydrocortisoneHydrocortisone
    68788-0645hydrocortisonehydrocortisone
    68788-9922HydrocortisoneHydrocortisone
    68788-9715HydrocortisoneHydrocortisone
    68788-9856HydrocortisoneHydrocortisone
    69396-003HydrocortisoneHydrocortisone
    69842-627hydrocortisonehydrocortisone
    70518-0143HydrocortisoneHydrocortisone
    70518-1360HydrocortisoneHydrocortisone
    0603-0535HydrocortisoneHydrocortisone
    0603-3901HydrocortisoneHydrocortisone
    0603-3900HydrocortisoneHydrocortisone
    0603-7781HydrocortisoneHydrocortisone
    0603-3899HydrocortisoneHydrocortisone
    71335-0812HydrocortisoneHydrocortisone
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.