clotrimazole

Generic: clotrimazole

Labeler: padagis us llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clotrimazole
Generic Name clotrimazole
Labeler padagis us llc
Dosage Form LOZENGE
Routes
ORAL
Active Ingredients

clotrimazole 10 mg/1

Manufacturer
Padagis US LLC

Identifiers & Regulatory

Product NDC 0574-0107
Product ID 0574-0107_c3d8e3ce-0429-4979-a91d-58dd19bbe996
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076763
Listing Expiration 2026-12-31
Marketing Start 2005-12-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05740107
Hyphenated Format 0574-0107

Supplemental Identifiers

RxCUI
309371
UPC
0305740107706
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 ANDA076763 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 140 LOZENGE in 1 BOTTLE, PLASTIC (0574-0107-14)
  • 70 LOZENGE in 1 BOTTLE, PLASTIC (0574-0107-70)
  • 70 PACKET in 1 BOX (0574-0107-77) / 1 LOZENGE in 1 PACKET
source: ndc

Packages (3)

0574-0107-14 140 LOZENGE in 1 BOTTLE, PLASTIC (0574-0107-14) 0574-0107-70 70 LOZENGE in 1 BOTTLE, PLASTIC (0574-0107-70) 0574-0107-77 70 PACKET in 1 BOX (0574-0107-77) / 1 LOZENGE in 1 PACKET

Ingredients (1)

clotrimazole (10 mg/1)

Linked Drug Pages (1)

Clotrimazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c3d8e3ce-0429-4979-a91d-58dd19bbe996", "openfda": {"nui": ["N0000175487", "M0002083"], "upc": ["0305740107706"], "unii": ["G07GZ97H65"], "rxcui": ["309371"], "spl_set_id": ["3f57ef51-8202-4d0b-95a8-d2df468b8d9a"], "pharm_class_cs": ["Azoles [CS]"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "manufacturer_name": ["Padagis US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "140 LOZENGE in 1 BOTTLE, PLASTIC (0574-0107-14)", "package_ndc": "0574-0107-14", "marketing_start_date": "20051201"}, {"sample": false, "description": "70 LOZENGE in 1 BOTTLE, PLASTIC (0574-0107-70)", "package_ndc": "0574-0107-70", "marketing_start_date": "20051201"}, {"sample": false, "description": "70 PACKET in 1 BOX (0574-0107-77)  / 1 LOZENGE in 1 PACKET", "package_ndc": "0574-0107-77", "marketing_start_date": "20051201"}], "brand_name": "Clotrimazole", "product_id": "0574-0107_c3d8e3ce-0429-4979-a91d-58dd19bbe996", "dosage_form": "LOZENGE", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "0574-0107", "generic_name": "clotrimazole", "labeler_name": "Padagis US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clotrimazole", "active_ingredients": [{"name": "CLOTRIMAZOLE", "strength": "10 mg/1"}], "application_number": "ANDA076763", "marketing_category": "ANDA", "marketing_start_date": "20051201", "listing_expiration_date": "20261231"}