nystatin

Generic: nystatin

Labeler: pai holdings, llc dba pai pharma
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nystatin
Generic Name nystatin
Labeler pai holdings, llc dba pai pharma
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

nystatin 100000 [USP'U]/mL

Manufacturer
PAI Holdings, LLC dba PAI Pharma

Identifiers & Regulatory

Product NDC 0121-0868
Product ID 0121-0868_15a142a2-4bb9-444e-8b22-73acf9f91f3b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203621
Listing Expiration 2026-12-31
Marketing Start 2020-07-17

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01210868
Hyphenated Format 0121-0868

Supplemental Identifiers

RxCUI
312055
UPC
0301210868023
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 (0121-0868-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0868-05)
  • 60 mL in 1 BOTTLE, DROPPER (0121-0868-02)
  • 473 mL in 1 BOTTLE (0121-0868-16)
  • 5 TRAY in 1 CASE (0121-0868-50) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0868-05)
source: ndc

Packages (4)

0121-0868-00 10 TRAY in 1 CASE (0121-0868-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0868-05) 0121-0868-02 60 mL in 1 BOTTLE, DROPPER (0121-0868-02) 0121-0868-16 473 mL in 1 BOTTLE (0121-0868-16) 0121-0868-50 5 TRAY in 1 CASE (0121-0868-50) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0868-05)

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": "15a142a2-4bb9-444e-8b22-73acf9f91f3b", "openfda": {"nui": ["N0000175498", "M0017172"], "upc": ["0301210868023"], "unii": ["BDF1O1C72E"], "rxcui": ["312055"], "spl_set_id": ["28b4e26e-206a-4e8a-abfe-774b780e91c3"], "pharm_class_cs": ["Polyenes [CS]"], "pharm_class_epc": ["Polyene Antifungal [EPC]"], "manufacturer_name": ["PAI Holdings, LLC dba PAI Pharma"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 TRAY in 1 CASE (0121-0868-00)  / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0868-05)", "package_ndc": "0121-0868-00", "marketing_start_date": "20200717"}, {"sample": false, "description": "60 mL in 1 BOTTLE, DROPPER (0121-0868-02)", "package_ndc": "0121-0868-02", "marketing_start_date": "20200717"}, {"sample": false, "description": "473 mL in 1 BOTTLE (0121-0868-16)", "package_ndc": "0121-0868-16", "marketing_start_date": "20200717"}, {"sample": false, "description": "5 TRAY in 1 CASE (0121-0868-50)  / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0868-05)", "package_ndc": "0121-0868-50", "marketing_start_date": "20200717"}], "brand_name": "Nystatin", "product_id": "0121-0868_15a142a2-4bb9-444e-8b22-73acf9f91f3b", "dosage_form": "SUSPENSION", "pharm_class": ["Polyene Antifungal [EPC]", "Polyenes [CS]"], "product_ndc": "0121-0868", "generic_name": "NYSTATIN", "labeler_name": "PAI Holdings, LLC dba PAI Pharma", "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": "20200717", "listing_expiration_date": "20261231"}