proctofoam hc

Generic: pramoxine hydrochloride hydrocortisone acetate

Labeler: viatris specialty llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name proctofoam hc
Generic Name pramoxine hydrochloride hydrocortisone acetate
Labeler viatris specialty llc
Dosage Form AEROSOL, FOAM
Routes
TOPICAL
Active Ingredients

hydrocortisone acetate 100 mg/10g, pramoxine hydrochloride 100 mg/10g

Manufacturer
Viatris Specialty LLC

Identifiers & Regulatory

Product NDC 0037-6822
Product ID 0037-6822_d63033a1-dca0-44f9-a6f3-210e38c2691e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA086195
Listing Expiration 2026-12-31
Marketing Start 2014-08-15

Pharmacologic Class

Classes
corticosteroid hormone receptor agonists [moa] corticosteroid [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00376822
Hyphenated Format 0037-6822

Supplemental Identifiers

RxCUI
828362 828364
UNII
3X7931PO74 88AYB867L5

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name proctofoam hc (source: ndc)
Generic Name pramoxine hydrochloride hydrocortisone acetate (source: ndc)
Application Number ANDA086195 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/10g
source: ndc
Packaging
  • 1 CANISTER in 1 CARTON (0037-6822-10) / 10 g in 1 CANISTER
source: ndc

Packages (1)

0037-6822-10 1 CANISTER in 1 CARTON (0037-6822-10) / 10 g in 1 CANISTER

Ingredients (2)

hydrocortisone acetate (100 mg/10g) pramoxine hydrochloride (100 mg/10g)

Linked Drug Pages (1)

PROCTOFOAM HC ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "d63033a1-dca0-44f9-a6f3-210e38c2691e", "openfda": {"unii": ["3X7931PO74", "88AYB867L5"], "rxcui": ["828362", "828364"], "spl_set_id": ["3831e931-ec0a-11e3-ac10-0800200c9a66"], "manufacturer_name": ["Viatris Specialty LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 CANISTER in 1 CARTON (0037-6822-10)  / 10 g in 1 CANISTER", "package_ndc": "0037-6822-10", "marketing_start_date": "20140815"}], "brand_name": "PROCTOFOAM HC", "product_id": "0037-6822_d63033a1-dca0-44f9-a6f3-210e38c2691e", "dosage_form": "AEROSOL, FOAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "0037-6822", "generic_name": "pramoxine hydrochloride hydrocortisone acetate", "labeler_name": "Viatris Specialty LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PROCTOFOAM", "brand_name_suffix": "HC", "active_ingredients": [{"name": "HYDROCORTISONE ACETATE", "strength": "100 mg/10g"}, {"name": "PRAMOXINE HYDROCHLORIDE", "strength": "100 mg/10g"}], "application_number": "ANDA086195", "marketing_category": "ANDA", "marketing_start_date": "20140815", "listing_expiration_date": "20261231"}