nystatin

Generic: nystatin

Labeler: torrent pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nystatin
Generic Name nystatin
Labeler torrent pharmaceuticals limited
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

nystatin 100000 U/g

Manufacturer
Torrent Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 13668-534
Product ID 13668-534_82487bf8-8bff-4d9b-8ab8-652f22004e75
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211838
Listing Expiration 2026-12-31
Marketing Start 2019-01-29

Pharmacologic Class

Established (EPC)
polyene antifungal [epc]
Chemical Structure
polyenes [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 13668534
Hyphenated Format 13668-534

Supplemental Identifiers

RxCUI
884308
UNII
BDF1O1C72E
NUI
N0000175498 M0017172

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 nystatin (source: ndc)
Generic Name nystatin (source: ndc)
Application Number ANDA211838 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 100000 U/g
source: ndc
Packaging
  • 15 g in 1 TUBE (13668-534-01)
  • 30 g in 1 TUBE (13668-534-02)
source: ndc

Packages (2)

13668-534-01 15 g in 1 TUBE (13668-534-01) 13668-534-02 30 g in 1 TUBE (13668-534-02)

Ingredients (1)

nystatin (100000 U/g)

Linked Drug Pages (1)

Nystatin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "82487bf8-8bff-4d9b-8ab8-652f22004e75", "openfda": {"nui": ["N0000175498", "M0017172"], "unii": ["BDF1O1C72E"], "rxcui": ["884308"], "spl_set_id": ["4949dea7-d2b9-4e0d-974a-39408fa174ba"], "pharm_class_cs": ["Polyenes [CS]"], "pharm_class_epc": ["Polyene Antifungal [EPC]"], "manufacturer_name": ["Torrent Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "15 g in 1 TUBE (13668-534-01)", "package_ndc": "13668-534-01", "marketing_start_date": "20190129"}, {"sample": false, "description": "30 g in 1 TUBE (13668-534-02)", "package_ndc": "13668-534-02", "marketing_start_date": "20190129"}], "brand_name": "Nystatin", "product_id": "13668-534_82487bf8-8bff-4d9b-8ab8-652f22004e75", "dosage_form": "OINTMENT", "pharm_class": ["Polyene Antifungal [EPC]", "Polyenes [CS]"], "product_ndc": "13668-534", "generic_name": "Nystatin", "labeler_name": "Torrent Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nystatin", "active_ingredients": [{"name": "NYSTATIN", "strength": "100000 U/g"}], "application_number": "ANDA211838", "marketing_category": "ANDA", "marketing_start_date": "20190129", "listing_expiration_date": "20261231"}