terconazole vaginal cream 0.8%

Generic: terconazole

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name terconazole vaginal cream 0.8%
Generic Name terconazole
Labeler a-s medication solutions
Dosage Form CREAM
Routes
VAGINAL
Active Ingredients

terconazole 8 mg/g

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-6299
Product ID 50090-6299_8878f816-8262-4172-b007-ce8e7ac089bb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021735
Listing Expiration 2026-12-31
Marketing Start 2005-02-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 500906299
Hyphenated Format 50090-6299

Supplemental Identifiers

RxCUI
313227
UNII
0KJ2VE664U
NUI
N0000175487 M0002083

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 terconazole vaginal cream 0.8% (source: ndc)
Generic Name terconazole (source: ndc)
Application Number NDA021735 (source: ndc)
Routes
VAGINAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/g
source: ndc
Packaging
  • 20 g in 1 TUBE, WITH APPLICATOR (50090-6299-0)
source: ndc

Packages (1)

50090-6299-0 20 g in 1 TUBE, WITH APPLICATOR (50090-6299-0)

Ingredients (1)

terconazole (8 mg/g)

Linked Drug Pages (1)

Terconazole Vaginal Cream 0.8% ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["VAGINAL"], "spl_id": "8878f816-8262-4172-b007-ce8e7ac089bb", "openfda": {"nui": ["N0000175487", "M0002083"], "unii": ["0KJ2VE664U"], "rxcui": ["313227"], "spl_set_id": ["9b1c38ac-ebf3-471c-bcdf-1ff8ad197f91"], "pharm_class_cs": ["Azoles [CS]"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "20 g in 1 TUBE, WITH APPLICATOR (50090-6299-0)", "package_ndc": "50090-6299-0", "marketing_start_date": "20221229"}], "brand_name": "Terconazole Vaginal Cream 0.8%", "product_id": "50090-6299_8878f816-8262-4172-b007-ce8e7ac089bb", "dosage_form": "CREAM", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "50090-6299", "generic_name": "terconazole", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Terconazole", "brand_name_suffix": "Vaginal Cream 0.8%", "active_ingredients": [{"name": "TERCONAZOLE", "strength": "8 mg/g"}], "application_number": "NDA021735", "marketing_category": "NDA", "marketing_start_date": "20050201", "listing_expiration_date": "20261231"}