hydrocortisone valerate

Generic: hydrocortisone valerate

Labeler: glenmark pharmaceuticals inc., usa
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydrocortisone valerate
Generic Name hydrocortisone valerate
Labeler glenmark pharmaceuticals inc., usa
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

hydrocortisone valerate 2 mg/g

Manufacturer
Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-836
Product ID 68462-836_555ffb0f-8e6b-4516-9e48-8dae3acf428f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211750
Listing Expiration 2026-12-31
Marketing Start 2019-03-05

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68462836
Hyphenated Format 68462-836

Supplemental Identifiers

RxCUI
1370750
UPC
0368462836477 0368462836170 0368462836651
UNII
68717P8FUZ

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 hydrocortisone valerate (source: ndc)
Generic Name hydrocortisone valerate (source: ndc)
Application Number ANDA211750 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (68462-836-17) / 15 g in 1 TUBE
  • 1 TUBE in 1 CARTON (68462-836-47) / 45 g in 1 TUBE
  • 1 TUBE in 1 CARTON (68462-836-65) / 60 g in 1 TUBE
source: ndc

Packages (3)

68462-836-17 1 TUBE in 1 CARTON (68462-836-17) / 15 g in 1 TUBE 68462-836-47 1 TUBE in 1 CARTON (68462-836-47) / 45 g in 1 TUBE 68462-836-65 1 TUBE in 1 CARTON (68462-836-65) / 60 g in 1 TUBE

Ingredients (1)

hydrocortisone valerate (2 mg/g)

Linked Drug Pages (1)

Hydrocortisone Valerate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "555ffb0f-8e6b-4516-9e48-8dae3acf428f", "openfda": {"upc": ["0368462836477", "0368462836170", "0368462836651"], "unii": ["68717P8FUZ"], "rxcui": ["1370750"], "spl_set_id": ["18db91a0-fe67-4740-8a37-d656707356f1"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (68462-836-17)  / 15 g in 1 TUBE", "package_ndc": "68462-836-17", "marketing_start_date": "20190305"}, {"sample": false, "description": "1 TUBE in 1 CARTON (68462-836-47)  / 45 g in 1 TUBE", "package_ndc": "68462-836-47", "marketing_start_date": "20190305"}, {"sample": false, "description": "1 TUBE in 1 CARTON (68462-836-65)  / 60 g in 1 TUBE", "package_ndc": "68462-836-65", "marketing_start_date": "20190305"}], "brand_name": "Hydrocortisone Valerate", "product_id": "68462-836_555ffb0f-8e6b-4516-9e48-8dae3acf428f", "dosage_form": "OINTMENT", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "68462-836", "generic_name": "HYDROCORTISONE VALERATE", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydrocortisone Valerate", "active_ingredients": [{"name": "HYDROCORTISONE VALERATE", "strength": "2 mg/g"}], "application_number": "ANDA211750", "marketing_category": "ANDA", "marketing_start_date": "20190305", "listing_expiration_date": "20261231"}