hydrocortisone valerate

Generic: hydrocortisone valerate

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

Drug Facts

Product Profile

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

hydrocortisone valerate 2 mg/g

Manufacturer
Cosette Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0713-0560
Product ID 0713-0560_0b46d11e-449c-315b-e063-6294a90a6e2a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211764
Listing Expiration 2026-12-31
Marketing Start 2021-05-03

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 07130560
Hyphenated Format 0713-0560

Supplemental Identifiers

RxCUI
1370750
UPC
0307130560603
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 ANDA211764 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (0713-0560-15) / 15 g in 1 TUBE
  • 1 TUBE in 1 CARTON (0713-0560-37) / 45 g in 1 TUBE
  • 1 TUBE in 1 CARTON (0713-0560-60) / 60 g in 1 TUBE
source: ndc

Packages (3)

0713-0560-15 1 TUBE in 1 CARTON (0713-0560-15) / 15 g in 1 TUBE 0713-0560-37 1 TUBE in 1 CARTON (0713-0560-37) / 45 g in 1 TUBE 0713-0560-60 1 TUBE in 1 CARTON (0713-0560-60) / 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": "0b46d11e-449c-315b-e063-6294a90a6e2a", "openfda": {"upc": ["0307130560603"], "unii": ["68717P8FUZ"], "rxcui": ["1370750"], "spl_set_id": ["1cb06573-1ac8-4dfe-8123-00bbd20a1650"], "manufacturer_name": ["Cosette Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (0713-0560-15)  / 15 g in 1 TUBE", "package_ndc": "0713-0560-15", "marketing_start_date": "20210503"}, {"sample": false, "description": "1 TUBE in 1 CARTON (0713-0560-37)  / 45 g in 1 TUBE", "package_ndc": "0713-0560-37", "marketing_start_date": "20210503"}, {"sample": false, "description": "1 TUBE in 1 CARTON (0713-0560-60)  / 60 g in 1 TUBE", "package_ndc": "0713-0560-60", "marketing_start_date": "20210503"}], "brand_name": "Hydrocortisone Valerate", "product_id": "0713-0560_0b46d11e-449c-315b-e063-6294a90a6e2a", "dosage_form": "OINTMENT", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "0713-0560", "generic_name": "HYDROCORTISONE VALERATE", "labeler_name": "Cosette Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydrocortisone Valerate", "active_ingredients": [{"name": "HYDROCORTISONE VALERATE", "strength": "2 mg/g"}], "application_number": "ANDA211764", "marketing_category": "ANDA", "marketing_start_date": "20210503", "listing_expiration_date": "20261231"}