clotrimazole and betamethasone dipropionate

Generic: clotrimazole and betamethasone dipropionate

Labeler: advanced rx pharmacy of tennessee, llc
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 advanced rx pharmacy of tennessee, llc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

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

Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0344
Product ID 80425-0344_2a9bfe6a-6d75-b262-e063-6294a90a1cf3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075673
Listing Expiration 2026-12-31
Marketing Start 2023-06-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 804250344
Hyphenated Format 80425-0344

Supplemental Identifiers

RxCUI
308714
UNII
826Y60901U G07GZ97H65
NUI
N0000175487 M0002083

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 ANDA075673 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/g
  • 10 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (80425-0344-1) / 15 g in 1 TUBE
source: ndc

Packages (1)

80425-0344-1 1 TUBE in 1 CARTON (80425-0344-1) / 15 g in 1 TUBE

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": "2a9bfe6a-6d75-b262-e063-6294a90a1cf3", "openfda": {"nui": ["N0000175487", "M0002083"], "unii": ["826Y60901U", "G07GZ97H65"], "rxcui": ["308714"], "spl_set_id": ["fe2ec7d2-23c2-e99f-e053-6294a90aa65a"], "pharm_class_cs": ["Azoles [CS]"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "manufacturer_name": ["Advanced Rx Pharmacy of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (80425-0344-1)  / 15 g in 1 TUBE", "package_ndc": "80425-0344-1", "marketing_start_date": "20230615"}], "brand_name": "Clotrimazole and Betamethasone Dipropionate", "product_id": "80425-0344_2a9bfe6a-6d75-b262-e063-6294a90a1cf3", "dosage_form": "CREAM", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]", "Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "80425-0344", "generic_name": "Clotrimazole and Betamethasone Dipropionate", "labeler_name": "Advanced Rx Pharmacy of Tennessee, LLC", "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": "ANDA075673", "marketing_category": "ANDA", "marketing_start_date": "20230615", "listing_expiration_date": "20261231"}