NDC 75834-197

HYDROCORTISONE ACETATE PRAMOXINE HYDROCHLORIDE

Pramoxine Hydrochloride And Hydrocortisone Acetate

HYDROCORTISONE ACETATE PRAMOXINE HYDROCHLORIDE is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Nivagen Pharmaceuticals Inc.. The primary component is Pramoxine Hydrochloride; Hydrocortisone Acetate.

Product ID75834-197_4421cc1e-f6b1-48ea-9698-de306d21e994
NDC75834-197
Product TypeHuman Prescription Drug
Proprietary NameHYDROCORTISONE ACETATE PRAMOXINE HYDROCHLORIDE
Generic NamePramoxine Hydrochloride And Hydrocortisone Acetate
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2019-04-29
Marketing CategoryUNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
Labeler NameNivagen Pharmaceuticals Inc.
Substance NamePRAMOXINE HYDROCHLORIDE; HYDROCORTISONE ACETATE
Active Ingredient Strength10 mg/g; mg/g
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 75834-197-01

1 TUBE, WITH APPLICATOR in 1 CARTON (75834-197-01) > 28.5 g in 1 TUBE, WITH APPLICATOR
Marketing Start Date2019-04-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 75834-197-01 [75834019701]

HYDROCORTISONE ACETATE PRAMOXINE HYDROCHLORIDE CREAM
Marketing CategoryUnapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2019-04-29

Drug Details

Active Ingredients

IngredientStrength
PRAMOXINE HYDROCHLORIDE10 mg/g

Pharmacological Class

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

NDC Crossover Matching brand name "HYDROCORTISONE ACETATE PRAMOXINE HYDROCHLORIDE" or generic name "Pramoxine Hydrochloride And Hydrocortisone Acetate"

NDCBrand NameGeneric Name
69367-285Hydrocortisone Acetate Pramoxine HydrochlorideHydrocortisone Acetate and Pramoxine Hydrochloride
73028-401Hydrocortisone Acetate Pramoxine HydrochlorideHydrocortisone Acetate and Pramoxine Hydrochloride
75834-197HYDROCORTISONE ACETATE PRAMOXINE HYDROCHLORIDEPRAMOXINE HYDROCHLORIDE and HYDROCORTISONE ACETATE
79043-240Hydrocortisone Acetate Pramoxine HydrochlorideHYDROCORTISONE ACETATE and PRAMOXINE HYDROCHLORIDE
0037-6824EPIFOAMpramoxine hydrochloride and hydrocortisone acetate

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