clotrimazole

Generic: clotrimazole

Labeler: strategic sourcing services llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clotrimazole
Generic Name clotrimazole
Labeler strategic sourcing services llc
Dosage Form CREAM
Routes
VAGINAL
Active Ingredients

clotrimazole 10 mg/g

Manufacturer
Strategic Sourcing Services LLC

Identifiers & Regulatory

Product NDC 70677-1228
Product ID 70677-1228_b3366848-77f9-443d-9116-8eaf16c7b51e
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA074165
Marketing Start 2023-09-01
Marketing End 2026-04-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 706771228
Hyphenated Format 70677-1228

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 in 1 CARTON (70677-1228-1) / 45 g in 1 TUBE
source: ndc

Packages (1)

70677-1228-1 1 TUBE in 1 CARTON (70677-1228-1) / 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": ["VAGINAL"], "spl_id": "b3366848-77f9-443d-9116-8eaf16c7b51e", "openfda": {"nui": ["N0000175487", "M0002083"], "unii": ["G07GZ97H65"], "rxcui": ["309368"], "spl_set_id": ["d5fe1c1a-900b-4439-80fa-3b0fc3ba142e"], "pharm_class_cs": ["Azoles [CS]"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "manufacturer_name": ["Strategic Sourcing Services LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (70677-1228-1)  / 45 g in 1 TUBE", "package_ndc": "70677-1228-1", "marketing_end_date": "20260430", "marketing_start_date": "20230901"}], "brand_name": "Clotrimazole", "product_id": "70677-1228_b3366848-77f9-443d-9116-8eaf16c7b51e", "dosage_form": "CREAM", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "70677-1228", "generic_name": "Clotrimazole", "labeler_name": "Strategic Sourcing Services 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_end_date": "20260430", "marketing_start_date": "20230901"}