clotrimazole and betamethasone dipropionate (68462-298)

Drug Facts

Product Profile

Brand Name clotrimazole and betamethasone dipropionate

Generic Name clotrimazole and betamethasone dipropionate

Labeler glenmark pharmaceuticals inc. usa

Dosage Form CREAM

Routes

TOPICAL

Active Ingredients

betamethasone dipropionate .5 mg/g, clotrimazole 10 mg/g

Manufacturer

Glenmark Pharmaceuticals Inc. USA

Identifiers & Regulatory

Product NDC 68462-298

Product ID 68462-298_2fc6dcb9-879f-4d6e-8194-4a30af922986

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA202894

Listing Expiration 2026-12-31

Marketing Start 2015-11-06

Pharmacologic Class

Established (EPC)

azole antifungal [epc]

Chemical Structure

azoles [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68462298

Hyphenated Format 68462-298

Supplemental Identifiers

RxCUI

308714

UPC

0368462298176 0368462298558

UNII

826Y60901U G07GZ97H65

NUI

N0000175487 M0002083

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 clotrimazole and betamethasone dipropionate (source: ndc)

Generic Name clotrimazole and betamethasone dipropionate (source: ndc)

Application Number ANDA202894 (source: ndc)

Routes

TOPICAL

source: ndc

Resolved Composition

Strengths

.5 mg/g
10 mg/g

source: ndc

Packaging

15 g in 1 TUBE (68462-298-17)
45 g in 1 TUBE (68462-298-55)

source: ndc

Packages (2)

68462-298-17 15 g in 1 TUBE (68462-298-17) 68462-298-55 45 g in 1 TUBE (68462-298-55)

Ingredients (2)

betamethasone dipropionate (.5 mg/g) clotrimazole (10 mg/g)

Linked Drug Pages (1)

Clotrimazole and Betamethasone Dipropionate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["TOPICAL"], "spl_id": "2fc6dcb9-879f-4d6e-8194-4a30af922986", "openfda": {"nui": ["N0000175487", "M0002083"], "upc": ["0368462298176", "0368462298558"], "unii": ["826Y60901U", "G07GZ97H65"], "rxcui": ["308714"], "spl_set_id": ["8dcd24cb-e568-428a-88ac-737d115cc54d"], "pharm_class_cs": ["Azoles [CS]"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc. USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "15 g in 1 TUBE (68462-298-17)", "package_ndc": "68462-298-17", "marketing_start_date": "20151106"}, {"sample": false, "description": "45 g in 1 TUBE (68462-298-55)", "package_ndc": "68462-298-55", "marketing_start_date": "20151106"}], "brand_name": "Clotrimazole and Betamethasone Dipropionate", "product_id": "68462-298_2fc6dcb9-879f-4d6e-8194-4a30af922986", "dosage_form": "CREAM", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]", "Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "68462-298", "generic_name": "Clotrimazole and Betamethasone Dipropionate", "labeler_name": "Glenmark Pharmaceuticals Inc. USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clotrimazole and Betamethasone Dipropionate", "active_ingredients": [{"name": "BETAMETHASONE DIPROPIONATE", "strength": ".5 mg/g"}, {"name": "CLOTRIMAZOLE", "strength": "10 mg/g"}], "application_number": "ANDA202894", "marketing_category": "ANDA", "marketing_start_date": "20151106", "listing_expiration_date": "20261231"}