NDC 52187-534

Hydrocortisone Acetate 2.5% Pramoxine HCl 1%

Hydrocortisone Acetate, Pramoxine Hcl

Hydrocortisone Acetate 2.5% Pramoxine HCl 1% is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Kmm Pharmaceuticals, Llc. The primary component is Hydrocortisone Acetate; Pramoxine Hydrochloride.

• Product ID: 52187-534_a2b93492-05a8-51dd-e053-2995a90a0004
• NDC: 52187-534
• Product Type: Human Prescription Drug
• Proprietary Name: Hydrocortisone Acetate 2.5% Pramoxine HCl 1%
• Generic Name: Hydrocortisone Acetate, Pramoxine Hcl
• Dosage Form: Cream
• Route of Administration: TOPICAL
• Marketing Start Date: 2020-04-07
• Marketing Category: UNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
• Labeler Name: KMM Pharmaceuticals, LLC
• Substance Name: HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE
• Active Ingredient Strength: 25 mg/g; mg/g
• Pharm Classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 52187-534-01

1 TUBE, WITH APPLICATOR in 1 CARTON (52187-534-01) > 30 g in 1 TUBE, WITH APPLICATOR

• Marketing Start Date: 2020-04-07
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 52187-534-01 [52187053401]

Hydrocortisone Acetate 2.5% Pramoxine HCl 1% CREAM

• Marketing Category: unapproved drug other
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2020-04-07

Drug Details

Active Ingredients

Ingredient	Strength
HYDROCORTISONE ACETATE	25 mg/g

OpenFDA Data

• SPL SET ID: a2b93492-05a7-51dd-e053-2995a90a0004
• Manufacturer:
  • KMM Pharmaceuticals, LLC
• UNII:
  • 88AYB867L5
  • 3X7931PO74
• RxNorm Concept Unique ID - RxCUI:
  • 1234506

Pharmacological Class

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

NDC Crossover Matching brand name "Hydrocortisone Acetate 2.5% Pramoxine HCl 1%" or generic name "Hydrocortisone Acetate, Pramoxine Hcl"

NDC	Brand Name	Generic Name
52187-533	Hydrocortisone Acetate 2.5% Pramoxine HCl 1%	HYDROCORTISONE ACETATE, PRAMOXINE HCl
52187-534	Hydrocortisone Acetate 2.5% Pramoxine HCl 1%	HYDROCORTISONE ACETATE, PRAMOXINE HCL
45802-124	hydrocortisone acetate pramoxine HCl	Hydrocortisone Acetate, Pramoxine HCl
52817-817	hydrocortisone acetate pramoxine HCl	Hydrocortisone Acetate, Pramoxine HCl
63629-8673	hydrocortisone acetate pramoxine HCl	Hydrocortisone Acetate, Pramoxine HCl
63629-8674	hydrocortisone acetate pramoxine HCl	Hydrocortisone Acetate, Pramoxine HCl