hydrocortisone valerate cream

Generic: hydrocortisone valerate cream

Labeler: encube ethicals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydrocortisone valerate cream
Generic Name hydrocortisone valerate cream
Labeler encube ethicals, inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

hydrocortisone valerate 2 mg/g

Manufacturer
Encube Ethicals, Inc.

Identifiers & Regulatory

Product NDC 21922-007
Product ID 21922-007_85b1a924-1037-419a-a141-878a1539f013
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211047
Listing Expiration 2026-12-31
Marketing Start 2022-12-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 21922007
Hyphenated Format 21922-007

Supplemental Identifiers

RxCUI
1370754
UPC
0321922007060 0321922007046
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 cream (source: ndc)
Generic Name hydrocortisone valerate cream (source: ndc)
Application Number ANDA211047 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (21922-007-04) / 15 g in 1 TUBE
  • 1 TUBE in 1 CARTON (21922-007-06) / 45 g in 1 TUBE
  • 1 TUBE in 1 CARTON (21922-007-07) / 60 g in 1 TUBE
source: ndc

Packages (3)

21922-007-04 1 TUBE in 1 CARTON (21922-007-04) / 15 g in 1 TUBE 21922-007-06 1 TUBE in 1 CARTON (21922-007-06) / 45 g in 1 TUBE 21922-007-07 1 TUBE in 1 CARTON (21922-007-07) / 60 g in 1 TUBE

Ingredients (1)

hydrocortisone valerate (2 mg/g)

Linked Drug Pages (1)

hydrocortisone valerate cream ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "85b1a924-1037-419a-a141-878a1539f013", "openfda": {"upc": ["0321922007060", "0321922007046"], "unii": ["68717P8FUZ"], "rxcui": ["1370754"], "spl_set_id": ["41723504-b2cf-4074-9c3a-e3c59bb48c98"], "manufacturer_name": ["Encube Ethicals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (21922-007-04)  / 15 g in 1 TUBE", "package_ndc": "21922-007-04", "marketing_start_date": "20221231"}, {"sample": false, "description": "1 TUBE in 1 CARTON (21922-007-06)  / 45 g in 1 TUBE", "package_ndc": "21922-007-06", "marketing_start_date": "20221231"}, {"sample": false, "description": "1 TUBE in 1 CARTON (21922-007-07)  / 60 g in 1 TUBE", "package_ndc": "21922-007-07", "marketing_start_date": "20221231"}], "brand_name": "hydrocortisone valerate cream", "product_id": "21922-007_85b1a924-1037-419a-a141-878a1539f013", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "21922-007", "generic_name": "hydrocortisone valerate cream", "labeler_name": "Encube Ethicals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "hydrocortisone valerate cream", "active_ingredients": [{"name": "HYDROCORTISONE VALERATE", "strength": "2 mg/g"}], "application_number": "ANDA211047", "marketing_category": "ANDA", "marketing_start_date": "20221231", "listing_expiration_date": "20261231"}