clobetasol propionate

Generic: clobetasol propionate

Labeler: northstar rx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clobetasol propionate
Generic Name clobetasol propionate
Labeler northstar rx llc
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

clobetasol propionate .5 mg/g

Manufacturer
Northstar Rx LLC

Identifiers & Regulatory

Product NDC 16714-782
Product ID 16714-782_683b22fa-b609-40de-8547-73b9d1120c22
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208933
Listing Expiration 2026-12-31
Marketing Start 2018-05-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16714782
Hyphenated Format 16714-782

Supplemental Identifiers

RxCUI
861448
UPC
0316714782034
UNII
779619577M

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 clobetasol propionate (source: ndc)
Generic Name clobetasol propionate (source: ndc)
Application Number ANDA208933 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/g
source: ndc
Packaging
  • HOW SUPPLIED Clobetasol Propionate Ointment USP, 0.05% is available as follows: NDC 16714-782-01 15 g tube (1 tube per carton) NDC 16714-782-02 30 g tube (1 tube per carton) NDC 16714-782-03 45 g tube (1 tube per carton) NDC 16714-782-04 60 g tube (1 tube per carton) Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Do not refrigerate and avoid freezing. Manufactured for: Northstar Rx LLC Memphis, TN 38141. Toll number: 1-800-206-7821 Manufactured by: Glenmark Pharmaceuticals Limited Baddi, Himachal Pradesh – 173205 India May 2021
  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL tube
  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL carton
source: label

Packages (0)

No package records.

Ingredients (1)

clobetasol propionate (.5 mg/g)

Linked Drug Pages (1)

Clobetasol Propionate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "683b22fa-b609-40de-8547-73b9d1120c22", "openfda": {"upc": ["0316714782034"], "unii": ["779619577M"], "rxcui": ["861448"], "spl_set_id": ["0d0e8e82-2b57-4cc0-a46b-bd08fb581deb"], "manufacturer_name": ["Northstar Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "Clobetasol Propionate", "product_id": "16714-782_683b22fa-b609-40de-8547-73b9d1120c22", "dosage_form": "OINTMENT", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "16714-782", "generic_name": "Clobetasol Propionate", "labeler_name": "Northstar Rx LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clobetasol Propionate", "active_ingredients": [{"name": "CLOBETASOL PROPIONATE", "strength": ".5 mg/g"}], "application_number": "ANDA208933", "marketing_category": "ANDA", "marketing_start_date": "20180501", "listing_expiration_date": "20261231"}