NDC 0316-0128

Alacort

Hydrocortisone

Alacort is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Crown Laboratories. The primary component is Hydrocortisone.

Product ID0316-0128_63280338-a048-d490-e053-2a91aa0a777f
NDC0316-0128
Product TypeHuman Prescription Drug
Proprietary NameAlacort
Generic NameHydrocortisone
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2016-01-06
Marketing CategoryANDA / ANDA
Application NumberANDA080706
Labeler NameCrown Laboratories
Substance NameHYDROCORTISONE
Active Ingredient Strength25 mg/g
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0316-0128-16

454 g in 1 JAR (0316-0128-16)
Marketing Start Date2016-01-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0316-0128-20 [00316012820]

Alacort CREAM
Marketing CategoryANDA
Application NumberANDA080706
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-01-06

NDC 0316-0128-30 [00316012830]

Alacort CREAM
Marketing CategoryANDA
Application NumberANDA080706
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2016-01-06

NDC 0316-0128-16 [00316012816]

Alacort CREAM
Marketing CategoryANDA
Application NumberANDA080706
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-01-06

Drug Details

Active Ingredients

IngredientStrength
HYDROCORTISONE25 mg/g

OpenFDA Data

SPL SET ID:de000081-a245-4f6b-9e7c-e47d84b82338
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1729511
  • 206347
  • 310891
  • 106258
    • UPC Code
  • 0303160128301
  • 0303160126017

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0316-0126AlacortAlacort
    0316-0128AlacortAlacort
    0096-0732Aquanil HCHydrocortisone
    0113-0793basic care hydrocortisonehydrocortisone
    0113-7369basic care hydrocortisoneHydrocortisone
    0113-7006Basic Case Hydrocortisone Anti-Itchhydrocortisone
    0009-0012CORTEFhydrocortisone
    0009-0031CORTEFhydrocortisone
    0009-0044CORTEFhydrocortisone
    0113-0471Good Sense Anti Itchhydrocortisone
    0113-0541good sense anti itchHydrocortisone
    0113-0973Good Sense Anti Itchhydrocortisone
    0113-1369good sense anti itchHydrocortisone
    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
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