nystatin

Generic: nystatin

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

Drug Facts

Product Profile

Brand Name nystatin
Generic Name nystatin
Labeler nucare pharmaceuticals,inc.
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

nystatin 100000 [USP'U]/mL

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-3543
Product ID 68071-3543_2ad1d4c2-cbc9-0304-e063-6394a90aae6e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214346
Listing Expiration 2026-12-31
Marketing Start 2022-12-05

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 680713543
Hyphenated Format 68071-3543

Supplemental Identifiers

RxCUI
312055
UPC
0368071354362
UNII
BDF1O1C72E
NUI
N0000175498 M0017172

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 ANDA214346 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100000 [USP'U]/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 PACKAGE (68071-3543-6) / 60 mL in 1 BOTTLE
source: ndc

Packages (1)

68071-3543-6 1 BOTTLE in 1 PACKAGE (68071-3543-6) / 60 mL in 1 BOTTLE

Ingredients (1)

nystatin (100000 [USP'U]/mL)

Linked Drug Pages (1)

NYSTATIN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2ad1d4c2-cbc9-0304-e063-6394a90aae6e", "openfda": {"nui": ["N0000175498", "M0017172"], "upc": ["0368071354362"], "unii": ["BDF1O1C72E"], "rxcui": ["312055"], "spl_set_id": ["0b4dfd5e-641e-40e9-e063-6294a90a3fda"], "pharm_class_cs": ["Polyenes [CS]"], "pharm_class_epc": ["Polyene Antifungal [EPC]"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 PACKAGE (68071-3543-6)  / 60 mL in 1 BOTTLE", "package_ndc": "68071-3543-6", "marketing_start_date": "20231129"}], "brand_name": "NYSTATIN", "product_id": "68071-3543_2ad1d4c2-cbc9-0304-e063-6394a90aae6e", "dosage_form": "SUSPENSION", "pharm_class": ["Polyene Antifungal [EPC]", "Polyenes [CS]"], "product_ndc": "68071-3543", "generic_name": "NYSTATIN", "labeler_name": "NuCare Pharmaceuticals,Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NYSTATIN", "active_ingredients": [{"name": "NYSTATIN", "strength": "100000 [USP'U]/mL"}], "application_number": "ANDA214346", "marketing_category": "ANDA", "marketing_start_date": "20221205", "listing_expiration_date": "20261231"}