nystatin

Generic: nystatin

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

Drug Facts

Product Profile

Brand Name nystatin
Generic Name nystatin
Labeler pharmaceutical associates, inc.
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

nystatin 100000 [USP'U]/mL

Manufacturer
Pharmaceutical Associates, Inc.

Identifiers & Regulatory

Product NDC 0121-4810
Product ID 0121-4810_d57cde69-0eb9-180d-e053-2995a90a33aa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203621
Listing Expiration 2026-12-31
Marketing Start 2016-02-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01214810
Hyphenated Format 0121-4810

Supplemental Identifiers

RxCUI
312055
UPC
0301210810022
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 ANDA203621 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100000 [USP'U]/mL
source: ndc
Packaging
  • 10 TRAY in 1 CASE (0121-4810-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE
  • 4 TRAY in 1 CASE (0121-4810-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-4810-05)
  • 5 PACKAGE in 1 CASE (0121-4810-50) / 10 CUP, UNIT-DOSE in 1 PACKAGE / 5 mL in 1 CUP, UNIT-DOSE
source: ndc

Packages (3)

0121-4810-00 10 TRAY in 1 CASE (0121-4810-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE 0121-4810-40 4 TRAY in 1 CASE (0121-4810-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-4810-05) 0121-4810-50 5 PACKAGE in 1 CASE (0121-4810-50) / 10 CUP, UNIT-DOSE in 1 PACKAGE / 5 mL in 1 CUP, UNIT-DOSE

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": "d57cde69-0eb9-180d-e053-2995a90a33aa", "openfda": {"nui": ["N0000175498", "M0017172"], "upc": ["0301210810022"], "unii": ["BDF1O1C72E"], "rxcui": ["312055"], "spl_set_id": ["31e3da10-5a7b-4bc5-8a4f-3e786b64c13a"], "pharm_class_cs": ["Polyenes [CS]"], "pharm_class_epc": ["Polyene Antifungal [EPC]"], "manufacturer_name": ["Pharmaceutical Associates, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 TRAY in 1 CASE (0121-4810-00)  / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE", "package_ndc": "0121-4810-00", "marketing_start_date": "20160201"}, {"sample": false, "description": "4 TRAY in 1 CASE (0121-4810-40)  / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-4810-05)", "package_ndc": "0121-4810-40", "marketing_start_date": "20160201"}, {"sample": false, "description": "5 PACKAGE in 1 CASE (0121-4810-50)  / 10 CUP, UNIT-DOSE in 1 PACKAGE / 5 mL in 1 CUP, UNIT-DOSE", "package_ndc": "0121-4810-50", "marketing_start_date": "20200626"}], "brand_name": "Nystatin", "product_id": "0121-4810_d57cde69-0eb9-180d-e053-2995a90a33aa", "dosage_form": "SUSPENSION", "pharm_class": ["Polyene Antifungal [EPC]", "Polyenes [CS]"], "product_ndc": "0121-4810", "generic_name": "NYSTATIN", "labeler_name": "Pharmaceutical Associates, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nystatin", "active_ingredients": [{"name": "NYSTATIN", "strength": "100000 [USP'U]/mL"}], "application_number": "ANDA203621", "marketing_category": "ANDA", "marketing_start_date": "20160201", "listing_expiration_date": "20261231"}