nystatin

Generic: nystatin cream

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

Drug Facts

Product Profile

Brand Name nystatin
Generic Name nystatin cream
Labeler cosette pharmaceuticals, inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

nystatin 100000 [USP'U]/g

Manufacturer
Cosette Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0713-0678
Product ID 0713-0678_ee0cb97f-1642-0dc0-e053-2995a90a8db3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA061966
Listing Expiration 2026-12-31
Marketing Start 2015-04-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 07130678
Hyphenated Format 0713-0678

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 cream (source: ndc)
Application Number ANDA061966 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 100000 [USP'U]/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (0713-0678-15) / 15 g in 1 TUBE
  • 1 TUBE in 1 CARTON (0713-0678-31) / 30 g in 1 TUBE
source: ndc

Packages (2)

0713-0678-15 1 TUBE in 1 CARTON (0713-0678-15) / 15 g in 1 TUBE 0713-0678-31 1 TUBE in 1 CARTON (0713-0678-31) / 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": "ee0cb97f-1642-0dc0-e053-2995a90a8db3", "openfda": {"nui": ["N0000175498", "M0017172"], "unii": ["BDF1O1C72E"], "rxcui": ["543546"], "spl_set_id": ["ec1b52af-d38e-eba1-e63c-dba4341d3af2"], "pharm_class_cs": ["Polyenes [CS]"], "pharm_class_epc": ["Polyene Antifungal [EPC]"], "manufacturer_name": ["Cosette Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (0713-0678-15)  / 15 g in 1 TUBE", "package_ndc": "0713-0678-15", "marketing_start_date": "20150401"}, {"sample": false, "description": "1 TUBE in 1 CARTON (0713-0678-31)  / 30 g in 1 TUBE", "package_ndc": "0713-0678-31", "marketing_start_date": "20150401"}], "brand_name": "Nystatin", "product_id": "0713-0678_ee0cb97f-1642-0dc0-e053-2995a90a8db3", "dosage_form": "CREAM", "pharm_class": ["Polyene Antifungal [EPC]", "Polyenes [CS]"], "product_ndc": "0713-0678", "generic_name": "Nystatin Cream", "labeler_name": "Cosette Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nystatin", "active_ingredients": [{"name": "NYSTATIN", "strength": "100000 [USP'U]/g"}], "application_number": "ANDA061966", "marketing_category": "ANDA", "marketing_start_date": "20150401", "listing_expiration_date": "20261231"}