proctosol-hc

Generic: hydrocortisone

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name proctosol-hc
Generic Name hydrocortisone
Labeler sun pharmaceutical industries, inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

hydrocortisone 25 mg/g

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 10631-407
Product ID 10631-407_38f87659-b6da-4111-e063-6294a90a522d
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 10631407
Hyphenated Format 10631-407

Supplemental Identifiers

RxCUI
310891 1540356
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 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 (10631-407-01) / 28.35 g in 1 TUBE
source: ndc

Packages (1)

10631-407-01 1 TUBE in 1 CARTON (10631-407-01) / 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": "38f87659-b6da-4111-e063-6294a90a522d", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["WI4X0X7BPJ"], "rxcui": ["310891", "1540356"], "spl_set_id": ["565284e7-4994-486b-8267-18bd166655ac"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (10631-407-01)  / 28.35 g in 1 TUBE", "package_ndc": "10631-407-01", "marketing_start_date": "20050428"}], "brand_name": "Proctosol-HC", "product_id": "10631-407_38f87659-b6da-4111-e063-6294a90a522d", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "10631-407", "generic_name": "Hydrocortisone", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "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"}