nystatin

Generic: nystatin

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

Drug Facts

Product Profile

Brand Name nystatin
Generic Name nystatin
Labeler sun pharmaceutical industries, inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

nystatin 100000 [USP'U]/g

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 51672-1289
Product ID 51672-1289_3908cf94-b2b6-30a4-e063-6394a90add43
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA064022
Listing Expiration 2026-12-31
Marketing Start 1993-01-28

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 516721289
Hyphenated Format 51672-1289

Supplemental Identifiers

RxCUI
543546
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 ANDA064022 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 100000 [USP'U]/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (51672-1289-1) / 15 g in 1 TUBE
  • 1 TUBE in 1 CARTON (51672-1289-2) / 30 g in 1 TUBE
source: ndc

Packages (2)

51672-1289-1 1 TUBE in 1 CARTON (51672-1289-1) / 15 g in 1 TUBE 51672-1289-2 1 TUBE in 1 CARTON (51672-1289-2) / 30 g in 1 TUBE

Ingredients (1)

nystatin (100000 [USP'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": "3908cf94-b2b6-30a4-e063-6394a90add43", "openfda": {"nui": ["N0000175498", "M0017172"], "unii": ["BDF1O1C72E"], "rxcui": ["543546"], "spl_set_id": ["4d845b3f-ca26-4c47-b424-b6d783cc10e5"], "pharm_class_cs": ["Polyenes [CS]"], "pharm_class_epc": ["Polyene Antifungal [EPC]"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (51672-1289-1)  / 15 g in 1 TUBE", "package_ndc": "51672-1289-1", "marketing_start_date": "19930128"}, {"sample": false, "description": "1 TUBE in 1 CARTON (51672-1289-2)  / 30 g in 1 TUBE", "package_ndc": "51672-1289-2", "marketing_start_date": "19930128"}], "brand_name": "Nystatin", "product_id": "51672-1289_3908cf94-b2b6-30a4-e063-6394a90add43", "dosage_form": "CREAM", "pharm_class": ["Polyene Antifungal [EPC]", "Polyenes [CS]"], "product_ndc": "51672-1289", "generic_name": "Nystatin", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nystatin", "active_ingredients": [{"name": "NYSTATIN", "strength": "100000 [USP'U]/g"}], "application_number": "ANDA064022", "marketing_category": "ANDA", "marketing_start_date": "19930128", "listing_expiration_date": "20261231"}