clotrimazole

Generic: clotrimazole

Labeler: glenmark pharmaceuticals inc., usa
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clotrimazole
Generic Name clotrimazole
Labeler glenmark pharmaceuticals inc., usa
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

clotrimazole 10 mg/g

Manufacturer
Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-181
Product ID 68462-181_23d83b26-b5da-4474-9468-4909134295d1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090219
Listing Expiration 2027-12-31
Marketing Start 2010-08-04

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68462181
Hyphenated Format 68462-181

Supplemental Identifiers

RxCUI
309367
UPC
0368462181355
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 (source: ndc)
Application Number ANDA090219 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/g
source: ndc
Packaging
  • 15 g in 1 TUBE (68462-181-17)
  • 30 g in 1 TUBE (68462-181-35)
  • 45 g in 1 TUBE (68462-181-47)
  • 2 TUBE in 1 CARTON (68462-181-48) / 45 g in 1 TUBE
source: ndc

Packages (4)

68462-181-17 15 g in 1 TUBE (68462-181-17) 68462-181-35 30 g in 1 TUBE (68462-181-35) 68462-181-47 45 g in 1 TUBE (68462-181-47) 68462-181-48 2 TUBE in 1 CARTON (68462-181-48) / 45 g in 1 TUBE

Ingredients (1)

clotrimazole (10 mg/g)

Linked Drug Pages (1)

Clotrimazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "23d83b26-b5da-4474-9468-4909134295d1", "openfda": {"nui": ["N0000175487", "M0002083"], "upc": ["0368462181355"], "unii": ["G07GZ97H65"], "rxcui": ["309367"], "spl_set_id": ["f6898117-14f3-42d2-bc0e-d296add3ad70"], "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 (68462-181-17)", "package_ndc": "68462-181-17", "marketing_start_date": "20100804"}, {"sample": false, "description": "30 g in 1 TUBE (68462-181-35)", "package_ndc": "68462-181-35", "marketing_start_date": "20100804"}, {"sample": false, "description": "45 g in 1 TUBE (68462-181-47)", "package_ndc": "68462-181-47", "marketing_start_date": "20100804"}, {"sample": false, "description": "2 TUBE in 1 CARTON (68462-181-48)  / 45 g in 1 TUBE", "package_ndc": "68462-181-48", "marketing_start_date": "20100804"}], "brand_name": "Clotrimazole", "product_id": "68462-181_23d83b26-b5da-4474-9468-4909134295d1", "dosage_form": "CREAM", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "68462-181", "generic_name": "Clotrimazole", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clotrimazole", "active_ingredients": [{"name": "CLOTRIMAZOLE", "strength": "10 mg/g"}], "application_number": "ANDA090219", "marketing_category": "ANDA", "marketing_start_date": "20100804", "listing_expiration_date": "20271231"}