proctocort

Generic: hydrocortisone

Labeler: salix pharmaceuticals, inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name proctocort
Generic Name hydrocortisone
Labeler salix pharmaceuticals, inc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

hydrocortisone 10 mg/g

Manufacturer
Salix Pharmaceuticals, Inc

Identifiers & Regulatory

Product NDC 65649-501
Product ID 65649-501_62bfc47a-1d14-4dd2-8020-56e01f4e89a7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA080706
Listing Expiration 2026-12-31
Marketing Start 2004-06-01

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 65649501
Hyphenated Format 65649-501

Supplemental Identifiers

RxCUI
106258 1865144
UNII
WI4X0X7BPJ
NUI
N0000175576 N0000175450

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 proctocort (source: ndc)
Generic Name hydrocortisone (source: ndc)
Application Number ANDA080706 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (65649-501-30) / 28.35 g in 1 TUBE
source: ndc

Packages (1)

65649-501-30 1 TUBE in 1 CARTON (65649-501-30) / 28.35 g in 1 TUBE

Ingredients (1)

hydrocortisone (10 mg/g)

Linked Drug Pages (1)

Proctocort ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "62bfc47a-1d14-4dd2-8020-56e01f4e89a7", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["WI4X0X7BPJ"], "rxcui": ["106258", "1865144"], "spl_set_id": ["8c318d15-30e4-4395-9aa9-4157d349fe70"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Salix Pharmaceuticals, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (65649-501-30)  / 28.35 g in 1 TUBE", "package_ndc": "65649-501-30", "marketing_start_date": "20040601"}], "brand_name": "Proctocort", "product_id": "65649-501_62bfc47a-1d14-4dd2-8020-56e01f4e89a7", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "65649-501", "generic_name": "HYDROCORTISONE", "labeler_name": "Salix Pharmaceuticals, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Proctocort", "active_ingredients": [{"name": "HYDROCORTISONE", "strength": "10 mg/g"}], "application_number": "ANDA080706", "marketing_category": "ANDA", "marketing_start_date": "20040601", "listing_expiration_date": "20261231"}