anusol hc

Generic: hydrocortisone

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

Drug Facts

Product Profile

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

hydrocortisone 25 mg/g

Manufacturer
Salix Pharmaceuticals, Inc

Identifiers & Regulatory

Product NDC 65649-401
Product ID 65649-401_1103c6ea-1e5c-465c-bae8-9d56dfa9a7cd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA088250
Listing Expiration 2026-12-31
Marketing Start 1984-06-06

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 65649401
Hyphenated Format 65649-401

Supplemental Identifiers

RxCUI
310891 1659445
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 anusol hc (source: ndc)
Generic Name hydrocortisone (source: ndc)
Application Number ANDA088250 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (65649-401-30) / 30 g in 1 TUBE
source: ndc

Packages (1)

65649-401-30 1 TUBE in 1 CARTON (65649-401-30) / 30 g in 1 TUBE

Ingredients (1)

hydrocortisone (25 mg/g)

Linked Drug Pages (1)

Anusol HC ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "1103c6ea-1e5c-465c-bae8-9d56dfa9a7cd", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["WI4X0X7BPJ"], "rxcui": ["310891", "1659445"], "spl_set_id": ["5a0439c8-50a0-4f85-9cb4-9e3a5b0c31e7"], "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 (65649-401-30)  / 30 g in 1 TUBE", "package_ndc": "65649-401-30", "marketing_start_date": "19840606"}], "brand_name": "Anusol HC", "product_id": "65649-401_1103c6ea-1e5c-465c-bae8-9d56dfa9a7cd", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "65649-401", "generic_name": "hydrocortisone", "labeler_name": "Salix Pharmaceuticals, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Anusol", "brand_name_suffix": "HC", "active_ingredients": [{"name": "HYDROCORTISONE", "strength": "25 mg/g"}], "application_number": "ANDA088250", "marketing_category": "ANDA", "marketing_start_date": "19840606", "listing_expiration_date": "20261231"}