NDC 69837-010

Home PapKit

Hydrocortisone

Home PapKit is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by International Brand Management, Llc. The primary component is Hydrocortisone.

Product ID69837-010_25383117-5f5a-4ecb-bd6b-98e7cd1b6218
NDC69837-010
Product TypeHuman Prescription Drug
Proprietary NameHome PapKit
Generic NameHydrocortisone
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2016-09-15
Marketing CategoryANDA / ANDA
Application NumberANDA085027
Labeler NameInternational Brand Management, LLC
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 69837-010-02

1 TUBE in 1 CARTON (69837-010-02) > 28 g in 1 TUBE (69837-010-01)
Marketing Start Date2016-09-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69837-010-01 [69837001001]

Home PapKit CREAM
Marketing CategoryANDA
Application NumberANDA085027
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-09-15

NDC 69837-010-02 [69837001002]

Home PapKit CREAM
Marketing CategoryANDA
Application NumberANDA085027
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-09-15
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
HYDROCORTISONE25 mg/g

OpenFDA Data

SPL SET ID:caa9637a-73a7-4627-8bb6-74bc2b2f9291
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310891

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    69837-010Home PapKitHome PapKit
    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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