clotrimazole/betameth

Generic: clotrimazole/betameth

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clotrimazole/betameth
Generic Name clotrimazole/betameth
Labeler direct_rx
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

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

Manufacturer
Direct_Rx

Identifiers & Regulatory

Product NDC 72189-518
Product ID 72189-518_2c4e7cbb-554b-2c9d-e063-6294a90ada98
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076002
Listing Expiration 2026-12-31
Marketing Start 2023-10-25

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72189518
Hyphenated Format 72189-518

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/betameth (source: ndc)
Generic Name clotrimazole/betameth (source: ndc)
Application Number ANDA076002 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/g
  • 10 mg/g
source: ndc
Packaging
  • 15 g in 1 TUBE (72189-518-15)
source: ndc

Packages (1)

72189-518-15 15 g in 1 TUBE (72189-518-15)

Ingredients (2)

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

Linked Drug Pages (1)

Clotrimazole/Betameth ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "2c4e7cbb-554b-2c9d-e063-6294a90ada98", "openfda": {"nui": ["N0000175487", "M0002083"], "unii": ["826Y60901U", "G07GZ97H65"], "rxcui": ["308714"], "spl_set_id": ["08901233-7d36-e5d9-e063-6394a90af33d"], "pharm_class_cs": ["Azoles [CS]"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "manufacturer_name": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "15 g in 1 TUBE (72189-518-15)", "package_ndc": "72189-518-15", "marketing_start_date": "20231025"}], "brand_name": "Clotrimazole/Betameth", "product_id": "72189-518_2c4e7cbb-554b-2c9d-e063-6294a90ada98", "dosage_form": "CREAM", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]", "Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "72189-518", "generic_name": "Clotrimazole/Betameth", "labeler_name": "Direct_Rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clotrimazole/Betameth", "active_ingredients": [{"name": "BETAMETHASONE DIPROPIONATE", "strength": ".5 mg/g"}, {"name": "CLOTRIMAZOLE", "strength": "10 mg/g"}], "application_number": "ANDA076002", "marketing_category": "ANDA", "marketing_start_date": "20231025", "listing_expiration_date": "20261231"}