clotrimazole

Generic: clotrimazole

Labeler: h2-pharma, llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clotrimazole
Generic Name clotrimazole
Labeler h2-pharma, llc
Dosage Form CREAM
Routes
VAGINAL
Active Ingredients

clotrimazole 10 mg/g

Manufacturer
H2-Pharma, LLC

Identifiers & Regulatory

Product NDC 61269-220
Product ID 61269-220_1e5b4178-017f-429d-b0d9-bc11863cd67e
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA074165
Listing Expiration 2026-12-31
Marketing Start 2021-06-29

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 61269220
Hyphenated Format 61269-220

Supplemental Identifiers

RxCUI
309368
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 ANDA074165 (source: ndc)
Routes
VAGINAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/g
source: ndc
Packaging
  • 1 TUBE, WITH APPLICATOR in 1 CARTON (61269-220-41) / 45 g in 1 TUBE, WITH APPLICATOR
  • 1 TUBE, WITH APPLICATOR in 1 CARTON (61269-220-63) / 45 g in 1 TUBE, WITH APPLICATOR
source: ndc

Packages (2)

61269-220-41 1 TUBE, WITH APPLICATOR in 1 CARTON (61269-220-41) / 45 g in 1 TUBE, WITH APPLICATOR 61269-220-63 1 TUBE, WITH APPLICATOR in 1 CARTON (61269-220-63) / 45 g in 1 TUBE, WITH APPLICATOR

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": ["VAGINAL"], "spl_id": "1e5b4178-017f-429d-b0d9-bc11863cd67e", "openfda": {"nui": ["N0000175487", "M0002083"], "unii": ["G07GZ97H65"], "rxcui": ["309368"], "spl_set_id": ["388f7e35-efbe-496b-a8d6-518caa22328d"], "pharm_class_cs": ["Azoles [CS]"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "manufacturer_name": ["H2-Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE, WITH APPLICATOR in 1 CARTON (61269-220-41)  / 45 g in 1 TUBE, WITH APPLICATOR", "package_ndc": "61269-220-41", "marketing_start_date": "20210629"}, {"sample": false, "description": "1 TUBE, WITH APPLICATOR in 1 CARTON (61269-220-63)  / 45 g in 1 TUBE, WITH APPLICATOR", "package_ndc": "61269-220-63", "marketing_start_date": "20210629"}], "brand_name": "Clotrimazole", "product_id": "61269-220_1e5b4178-017f-429d-b0d9-bc11863cd67e", "dosage_form": "CREAM", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "61269-220", "generic_name": "Clotrimazole", "labeler_name": "H2-Pharma, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Clotrimazole", "active_ingredients": [{"name": "CLOTRIMAZOLE", "strength": "10 mg/g"}], "application_number": "ANDA074165", "marketing_category": "ANDA", "marketing_start_date": "20210629", "listing_expiration_date": "20261231"}