terconazole

Generic: terconazole

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name terconazole
Generic Name terconazole
Labeler sun pharmaceutical industries, inc.
Dosage Form SUPPOSITORY
Routes
VAGINAL
Active Ingredients

terconazole 80 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 51672-1330
Product ID 51672-1330_3961c135-42f6-e0a2-e063-6394a90a2e33
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077553
Listing Expiration 2026-12-31
Marketing Start 2007-03-09

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 516721330
Hyphenated Format 51672-1330

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
  • 1 DOSE PACK in 1 CARTON (51672-1330-3) / 3 SUPPOSITORY in 1 DOSE PACK
source: ndc

Packages (1)

51672-1330-3 1 DOSE PACK in 1 CARTON (51672-1330-3) / 3 SUPPOSITORY in 1 DOSE 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": "3961c135-42f6-e0a2-e063-6394a90a2e33", "openfda": {"nui": ["N0000175487", "M0002083"], "unii": ["0KJ2VE664U"], "rxcui": ["198245"], "spl_set_id": ["b4f50a11-bd39-4023-9145-2da60f6b085f"], "pharm_class_cs": ["Azoles [CS]"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 DOSE PACK in 1 CARTON (51672-1330-3)  / 3 SUPPOSITORY in 1 DOSE PACK", "package_ndc": "51672-1330-3", "marketing_start_date": "20070309"}], "brand_name": "Terconazole", "product_id": "51672-1330_3961c135-42f6-e0a2-e063-6394a90a2e33", "dosage_form": "SUPPOSITORY", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "51672-1330", "generic_name": "Terconazole", "labeler_name": "Sun Pharmaceutical Industries, 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": "20070309", "listing_expiration_date": "20261231"}