clotrimazole

Generic: clotrimazole topical

Labeler: novitium pharma llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clotrimazole
Generic Name clotrimazole topical
Labeler novitium pharma llc
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

clotrimazole 10 mg/mL

Manufacturer
Novitium Pharma LLC

Identifiers & Regulatory

Product NDC 70954-036
Product ID 70954-036_7d0a148e-294d-4975-9937-5244473f665d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209815
Listing Expiration 2026-12-31
Marketing Start 2019-02-18

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70954036
Hyphenated Format 70954-036

Supplemental Identifiers

RxCUI
309370
UPC
0370954036203
UNII
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 (source: ndc)
Generic Name clotrimazole topical (source: ndc)
Application Number ANDA209815 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (70954-036-20) / 30 mL in 1 BOTTLE
source: ndc

Packages (1)

70954-036-20 1 BOTTLE in 1 CARTON (70954-036-20) / 30 mL in 1 BOTTLE

Ingredients (1)

clotrimazole (10 mg/mL)

Linked Drug Pages (1)

Clotrimazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "7d0a148e-294d-4975-9937-5244473f665d", "openfda": {"nui": ["N0000175487", "M0002083"], "upc": ["0370954036203"], "unii": ["G07GZ97H65"], "rxcui": ["309370"], "spl_set_id": ["02df90b9-4879-4e73-b03a-0e96f3d099ea"], "pharm_class_cs": ["Azoles [CS]"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "manufacturer_name": ["Novitium Pharma LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (70954-036-20)  / 30 mL in 1 BOTTLE", "package_ndc": "70954-036-20", "marketing_start_date": "20190218"}], "brand_name": "Clotrimazole", "product_id": "70954-036_7d0a148e-294d-4975-9937-5244473f665d", "dosage_form": "SOLUTION", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "70954-036", "generic_name": "Clotrimazole topical", "labeler_name": "Novitium Pharma LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clotrimazole", "active_ingredients": [{"name": "CLOTRIMAZOLE", "strength": "10 mg/mL"}], "application_number": "ANDA209815", "marketing_category": "ANDA", "marketing_start_date": "20190218", "listing_expiration_date": "20261231"}