proctosol-hc

Generic: hydrocortisone

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

Drug Facts

Product Profile

Brand Name proctosol-hc
Generic Name hydrocortisone
Labeler bryant ranch prepack
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

hydrocortisone 25 mg/g

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 72162-2165
Product ID 72162-2165_33134cc8-52fb-4b1d-adf4-05ecf58c6941
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA088799
Listing Expiration 2026-12-31
Marketing Start 2005-04-28

Pharmacologic Class

Established (EPC)
corticosteroid [epc]
Mechanism of Action
corticosteroid hormone receptor agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 721622165
Hyphenated Format 72162-2165

Supplemental Identifiers

RxCUI
310891 1540356
UNII
WI4X0X7BPJ
NUI
N0000175576 N0000175450

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 proctosol-hc (source: ndc)
Generic Name hydrocortisone (source: ndc)
Application Number ANDA088799 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (72162-2165-2) / 28.35 g in 1 TUBE
source: ndc

Packages (1)

72162-2165-2 1 TUBE in 1 CARTON (72162-2165-2) / 28.35 g in 1 TUBE

Ingredients (1)

hydrocortisone (25 mg/g)

Linked Drug Pages (1)

Proctosol-HC ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "33134cc8-52fb-4b1d-adf4-05ecf58c6941", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["WI4X0X7BPJ"], "rxcui": ["310891", "1540356"], "spl_set_id": ["68e177fd-87aa-45f3-a380-0d092abdb77d"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (72162-2165-2)  / 28.35 g in 1 TUBE", "package_ndc": "72162-2165-2", "marketing_start_date": "20231207"}], "brand_name": "Proctosol-HC", "product_id": "72162-2165_33134cc8-52fb-4b1d-adf4-05ecf58c6941", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "72162-2165", "generic_name": "Hydrocortisone", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Proctosol-HC", "active_ingredients": [{"name": "HYDROCORTISONE", "strength": "25 mg/g"}], "application_number": "ANDA088799", "marketing_category": "ANDA", "marketing_start_date": "20050428", "listing_expiration_date": "20261231"}