terconazole

Generic: terconazole

Labeler: cosette pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name terconazole
Generic Name terconazole
Labeler cosette pharmaceuticals, inc.
Dosage Form SUPPOSITORY
Routes
VAGINAL
Active Ingredients

terconazole 80 mg/1

Manufacturer
Cosette Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0713-0552
Product ID 0713-0552_ee20ae91-d9b6-6f7f-e053-2a95a90a3171
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077553
Listing Expiration 2026-12-31
Marketing Start 2015-09-25

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 07130552
Hyphenated Format 0713-0552

Supplemental Identifiers

RxCUI
198245
UNII
0KJ2VE664U
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 terconazole (source: ndc)
Generic Name terconazole (source: ndc)
Application Number ANDA077553 (source: ndc)
Routes
VAGINAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 CARTON (0713-0552-73) / 1 SUPPOSITORY in 1 BLISTER PACK
source: ndc

Packages (1)

0713-0552-73 3 BLISTER PACK in 1 CARTON (0713-0552-73) / 1 SUPPOSITORY in 1 BLISTER PACK

Ingredients (1)

terconazole (80 mg/1)

Linked Drug Pages (1)

Terconazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["VAGINAL"], "spl_id": "ee20ae91-d9b6-6f7f-e053-2a95a90a3171", "openfda": {"nui": ["N0000175487", "M0002083"], "unii": ["0KJ2VE664U"], "rxcui": ["198245"], "spl_set_id": ["38cd1718-6b3c-415d-a17f-7b399adb0ba2"], "pharm_class_cs": ["Azoles [CS]"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "manufacturer_name": ["Cosette Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (0713-0552-73)  / 1 SUPPOSITORY in 1 BLISTER PACK", "package_ndc": "0713-0552-73", "marketing_start_date": "20150925"}], "brand_name": "Terconazole", "product_id": "0713-0552_ee20ae91-d9b6-6f7f-e053-2a95a90a3171", "dosage_form": "SUPPOSITORY", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "0713-0552", "generic_name": "Terconazole", "labeler_name": "Cosette Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Terconazole", "active_ingredients": [{"name": "TERCONAZOLE", "strength": "80 mg/1"}], "application_number": "ANDA077553", "marketing_category": "ANDA", "marketing_start_date": "20150925", "listing_expiration_date": "20261231"}