nystatin

Generic: nystatin

Labeler: northstar rx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nystatin
Generic Name nystatin
Labeler northstar rx llc
Dosage Form POWDER
Routes
TOPICAL
Active Ingredients

nystatin 100000 [USP'U]/g

Manufacturer
Northstar Rx LLC

Identifiers & Regulatory

Product NDC 72603-491
Product ID 72603-491_e7bbfa6e-9723-4309-97d3-76fe9a0cfde6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA064118
Listing Expiration 2027-12-31
Marketing Start 2025-09-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72603491
Hyphenated Format 72603-491

Supplemental Identifiers

RxCUI
646456
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 ANDA064118 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 100000 [USP'U]/g
source: ndc
Packaging
  • 15 g in 1 BOTTLE, PLASTIC (72603-491-01)
  • 30 g in 1 BOTTLE, PLASTIC (72603-491-02)
  • 60 g in 1 BOTTLE, PLASTIC (72603-491-03)
source: ndc

Packages (3)

72603-491-01 15 g in 1 BOTTLE, PLASTIC (72603-491-01) 72603-491-02 30 g in 1 BOTTLE, PLASTIC (72603-491-02) 72603-491-03 60 g in 1 BOTTLE, PLASTIC (72603-491-03)

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": "e7bbfa6e-9723-4309-97d3-76fe9a0cfde6", "openfda": {"nui": ["N0000175498", "M0017172"], "unii": ["BDF1O1C72E"], "rxcui": ["646456"], "spl_set_id": ["9e6d0b0d-a68f-46aa-a707-3110ecb931b4"], "pharm_class_cs": ["Polyenes [CS]"], "pharm_class_epc": ["Polyene Antifungal [EPC]"], "manufacturer_name": ["Northstar Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "15 g in 1 BOTTLE, PLASTIC (72603-491-01)", "package_ndc": "72603-491-01", "marketing_start_date": "20250901"}, {"sample": false, "description": "30 g in 1 BOTTLE, PLASTIC (72603-491-02)", "package_ndc": "72603-491-02", "marketing_start_date": "20250901"}, {"sample": false, "description": "60 g in 1 BOTTLE, PLASTIC (72603-491-03)", "package_ndc": "72603-491-03", "marketing_start_date": "20250901"}], "brand_name": "Nystatin", "product_id": "72603-491_e7bbfa6e-9723-4309-97d3-76fe9a0cfde6", "dosage_form": "POWDER", "pharm_class": ["Polyene Antifungal [EPC]", "Polyenes [CS]"], "product_ndc": "72603-491", "generic_name": "Nystatin", "labeler_name": "Northstar Rx LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nystatin", "active_ingredients": [{"name": "NYSTATIN", "strength": "100000 [USP'U]/g"}], "application_number": "ANDA064118", "marketing_category": "ANDA", "marketing_start_date": "20250901", "listing_expiration_date": "20271231"}