hydrocortisone valerate

Generic: hydrocortisone valerate

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

Drug Facts

Product Profile

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

hydrocortisone valerate 2 mg/g

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-954
Product ID 68180-954_a6615fbc-add1-481b-98e0-afd117c7a599
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210307
Listing Expiration 2027-12-31
Marketing Start 2019-11-19

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68180954
Hyphenated Format 68180-954

Supplemental Identifiers

RxCUI
1370754
UPC
0368180954019
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 ANDA210307 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (68180-954-01) / 15 g in 1 TUBE
  • 1 TUBE in 1 CARTON (68180-954-02) / 45 g in 1 TUBE
  • 1 TUBE in 1 CARTON (68180-954-03) / 60 g in 1 TUBE
source: ndc

Packages (3)

68180-954-01 1 TUBE in 1 CARTON (68180-954-01) / 15 g in 1 TUBE 68180-954-02 1 TUBE in 1 CARTON (68180-954-02) / 45 g in 1 TUBE 68180-954-03 1 TUBE in 1 CARTON (68180-954-03) / 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": "a6615fbc-add1-481b-98e0-afd117c7a599", "openfda": {"upc": ["0368180954019"], "unii": ["68717P8FUZ"], "rxcui": ["1370754"], "spl_set_id": ["17e93b8c-aede-4cab-9a8c-0c29abdb05f2"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (68180-954-01)  / 15 g in 1 TUBE", "package_ndc": "68180-954-01", "marketing_start_date": "20191119"}, {"sample": false, "description": "1 TUBE in 1 CARTON (68180-954-02)  / 45 g in 1 TUBE", "package_ndc": "68180-954-02", "marketing_start_date": "20191119"}, {"sample": false, "description": "1 TUBE in 1 CARTON (68180-954-03)  / 60 g in 1 TUBE", "package_ndc": "68180-954-03", "marketing_start_date": "20191119"}], "brand_name": "HYDROCORTISONE VALERATE", "product_id": "68180-954_a6615fbc-add1-481b-98e0-afd117c7a599", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "68180-954", "generic_name": "HYDROCORTISONE VALERATE", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "HYDROCORTISONE VALERATE", "active_ingredients": [{"name": "HYDROCORTISONE VALERATE", "strength": "2 mg/g"}], "application_number": "ANDA210307", "marketing_category": "ANDA", "marketing_start_date": "20191119", "listing_expiration_date": "20271231"}