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 CREAM
Routes
VAGINAL
Active Ingredients

terconazole 4 mg/g

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 51672-1304
Product ID 51672-1304_362a84ff-741f-ed45-e063-6394a90a54e7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076043
Listing Expiration 2026-12-31
Marketing Start 2005-01-19

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 516721304
Hyphenated Format 51672-1304

Supplemental Identifiers

RxCUI
313226
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 ANDA076043 (source: ndc)
Routes
VAGINAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/g
source: ndc
Packaging
  • 1 TUBE, WITH APPLICATOR in 1 CARTON (51672-1304-6) / 45 g in 1 TUBE, WITH APPLICATOR
source: ndc

Packages (1)

51672-1304-6 1 TUBE, WITH APPLICATOR in 1 CARTON (51672-1304-6) / 45 g in 1 TUBE, WITH APPLICATOR

Ingredients (1)

terconazole (4 mg/g)

Linked Drug Pages (1)

Terconazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["VAGINAL"], "spl_id": "362a84ff-741f-ed45-e063-6394a90a54e7", "openfda": {"nui": ["N0000175487", "M0002083"], "unii": ["0KJ2VE664U"], "rxcui": ["313226"], "spl_set_id": ["2b3923b5-0a97-428c-b8d2-4a3ceb3447a1"], "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 TUBE, WITH APPLICATOR in 1 CARTON (51672-1304-6)  / 45 g in 1 TUBE, WITH APPLICATOR", "package_ndc": "51672-1304-6", "marketing_start_date": "20050119"}], "brand_name": "Terconazole", "product_id": "51672-1304_362a84ff-741f-ed45-e063-6394a90a54e7", "dosage_form": "CREAM", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "51672-1304", "generic_name": "Terconazole", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Terconazole", "active_ingredients": [{"name": "TERCONAZOLE", "strength": "4 mg/g"}], "application_number": "ANDA076043", "marketing_category": "ANDA", "marketing_start_date": "20050119", "listing_expiration_date": "20261231"}