hydrocortisone acetate pramoxine hcl

Generic: hydrocortisone acetate pramoxine hcl

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydrocortisone acetate pramoxine hcl
Generic Name hydrocortisone acetate pramoxine hcl
Labeler bryant ranch prepack
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

hydrocortisone acetate 1 g/100g, pramoxine hydrochloride 1 g/100g

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-8669
Product ID 63629-8669_8172f406-59b6-4b90-8ffd-f408d1799b71
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA085368
Listing Expiration 2026-12-31
Marketing Start 2010-04-13

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 636298669
Hyphenated Format 63629-8669

Supplemental Identifiers

RxCUI
1235049
UNII
3X7931PO74 88AYB867L5

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 hydrocortisone acetate pramoxine hcl (source: ndc)
Generic Name hydrocortisone acetate pramoxine hcl (source: ndc)
Application Number ANDA085368 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1 g/100g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (63629-8669-1) / 28.35 g in 1 TUBE
source: ndc

Packages (1)

63629-8669-1 1 TUBE in 1 CARTON (63629-8669-1) / 28.35 g in 1 TUBE

Ingredients (2)

hydrocortisone acetate (1 g/100g) pramoxine hydrochloride (1 g/100g)

Linked Drug Pages (1)

hydrocortisone acetate pramoxine hcl ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "8172f406-59b6-4b90-8ffd-f408d1799b71", "openfda": {"unii": ["3X7931PO74", "88AYB867L5"], "rxcui": ["1235049"], "spl_set_id": ["3c5e1833-9908-4e4f-bdf2-7a28c14a585c"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (63629-8669-1)  / 28.35 g in 1 TUBE", "package_ndc": "63629-8669-1", "marketing_start_date": "20100413"}], "brand_name": "hydrocortisone acetate pramoxine hcl", "product_id": "63629-8669_8172f406-59b6-4b90-8ffd-f408d1799b71", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "63629-8669", "generic_name": "hydrocortisone acetate pramoxine hcl", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "hydrocortisone acetate pramoxine hcl", "active_ingredients": [{"name": "HYDROCORTISONE ACETATE", "strength": "1 g/100g"}, {"name": "PRAMOXINE HYDROCHLORIDE", "strength": "1 g/100g"}], "application_number": "ANDA085368", "marketing_category": "ANDA", "marketing_start_date": "20100413", "listing_expiration_date": "20261231"}