clotrimazole and betamethasone dipropionate

Generic: clotrimazole and betamethasone dipropionate

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clotrimazole and betamethasone dipropionate
Generic Name clotrimazole and betamethasone dipropionate
Labeler sun pharmaceutical industries, inc.
Dosage Form LOTION
Routes
TOPICAL
Active Ingredients

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

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 51672-1308
Product ID 51672-1308_395c949b-3bfb-410d-e063-6394a90ad1d0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076493
Listing Expiration 2026-12-31
Marketing Start 2004-07-28

Pharmacologic Class

Established (EPC)
azole antifungal [epc]
Chemical Structure
azoles [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 516721308
Hyphenated Format 51672-1308

Supplemental Identifiers

RxCUI
308715
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 ANDA076493 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/mL
  • 10 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (51672-1308-3) / 30 mL in 1 BOTTLE
source: ndc

Packages (1)

51672-1308-3 1 BOTTLE in 1 CARTON (51672-1308-3) / 30 mL in 1 BOTTLE

Ingredients (2)

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

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": "395c949b-3bfb-410d-e063-6394a90ad1d0", "openfda": {"nui": ["N0000175487", "M0002083"], "unii": ["826Y60901U", "G07GZ97H65"], "rxcui": ["308715"], "spl_set_id": ["e4e9f244-4a85-4c0d-9917-93182c4a6e87"], "pharm_class_cs": ["Azoles [CS]"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (51672-1308-3)  / 30 mL in 1 BOTTLE", "package_ndc": "51672-1308-3", "marketing_start_date": "20040728"}], "brand_name": "Clotrimazole and Betamethasone Dipropionate", "product_id": "51672-1308_395c949b-3bfb-410d-e063-6394a90ad1d0", "dosage_form": "LOTION", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]", "Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "51672-1308", "generic_name": "Clotrimazole and Betamethasone Dipropionate", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clotrimazole and Betamethasone Dipropionate", "active_ingredients": [{"name": "BETAMETHASONE DIPROPIONATE", "strength": ".5 mg/mL"}, {"name": "CLOTRIMAZOLE", "strength": "10 mg/mL"}], "application_number": "ANDA076493", "marketing_category": "ANDA", "marketing_start_date": "20040728", "listing_expiration_date": "20261231"}