clotrimazole

Generic: clotrimazole

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clotrimazole
Generic Name clotrimazole
Labeler rising pharma holdings, inc.
Dosage Form LOZENGE
Routes
ORAL
Active Ingredients

clotrimazole 10 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 16571-686
Product ID 16571-686_de2c09da-6280-4873-859a-80e779643612
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215641
Listing Expiration 2026-12-31
Marketing Start 2024-05-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16571686
Hyphenated Format 16571-686

Supplemental Identifiers

RxCUI
309371
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 ANDA215641 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 70 LOZENGE in 1 BOTTLE (16571-686-07)
  • 140 LOZENGE in 1 BOTTLE (16571-686-14)
source: ndc

Packages (2)

16571-686-07 70 LOZENGE in 1 BOTTLE (16571-686-07) 16571-686-14 140 LOZENGE in 1 BOTTLE (16571-686-14)

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": "de2c09da-6280-4873-859a-80e779643612", "openfda": {"nui": ["N0000175487", "M0002083"], "unii": ["G07GZ97H65"], "rxcui": ["309371"], "spl_set_id": ["980736aa-751a-4642-ab85-a309435fd02f"], "pharm_class_cs": ["Azoles [CS]"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "70 LOZENGE in 1 BOTTLE (16571-686-07)", "package_ndc": "16571-686-07", "marketing_start_date": "20240501"}, {"sample": false, "description": "140 LOZENGE in 1 BOTTLE (16571-686-14)", "package_ndc": "16571-686-14", "marketing_start_date": "20240501"}], "brand_name": "CLOTRIMAZOLE", "product_id": "16571-686_de2c09da-6280-4873-859a-80e779643612", "dosage_form": "LOZENGE", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "16571-686", "generic_name": "CLOTRIMAZOLE", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CLOTRIMAZOLE", "active_ingredients": [{"name": "CLOTRIMAZOLE", "strength": "10 mg/1"}], "application_number": "ANDA215641", "marketing_category": "ANDA", "marketing_start_date": "20240501", "listing_expiration_date": "20261231"}