Package 0121-1045-16

Brand: nystatin

Generic: nystatin
NDC Package

Package Facts

Identity

Package NDC 0121-1045-16
Digits Only 0121104516
Product NDC 0121-1045
Product ID 0121-1045_4901e044-ed1c-4f55-add3-c33e1399f91a
Description

473 mL in 1 BOTTLE (0121-1045-16)

Marketing

Marketing Status
Marketed Since 2024-06-21
Brand nystatin
Generic nystatin
Sample Package No

Linked Drug Pages (1)

Nystatin ndc-match (0.95)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4901e044-ed1c-4f55-add3-c33e1399f91a", "openfda": {"nui": ["N0000175498", "M0017172"], "unii": ["BDF1O1C72E"], "rxcui": ["312055"], "spl_set_id": ["05a8b8b6-3639-47b8-b7fc-47b105f5e6f9"], "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": "473 mL in 1 BOTTLE (0121-1045-16)", "package_ndc": "0121-1045-16", "marketing_start_date": "20240621"}], "brand_name": "Nystatin", "product_id": "0121-1045_4901e044-ed1c-4f55-add3-c33e1399f91a", "dosage_form": "SUSPENSION", "pharm_class": ["Polyene Antifungal [EPC]", "Polyenes [CS]"], "product_ndc": "0121-1045", "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": "20240621", "listing_expiration_date": "20261231"}