nystatin

Generic: nystatin

Labeler: cardinal health 107, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nystatin
Generic Name nystatin
Labeler cardinal health 107, llc
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

nystatin 100000 [USP'U]/mL

Manufacturer
Cardinal Health 107, LLC

Identifiers & Regulatory

Product NDC 55154-4314
Product ID 55154-4314_c6dbde35-e0a0-4f55-be3e-471aeb0b0302
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 551544314
Hyphenated Format 55154-4314

Supplemental Identifiers

RxCUI
312055
UPC
0055154431453
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 ANDA203621 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100000 [USP'U]/mL
source: ndc
Packaging
  • 5 CUP, UNIT-DOSE in 1 BAG (55154-4314-5) / 5 mL in 1 CUP, UNIT-DOSE
source: ndc

Packages (1)

55154-4314-5 5 CUP, UNIT-DOSE in 1 BAG (55154-4314-5) / 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": "c6dbde35-e0a0-4f55-be3e-471aeb0b0302", "openfda": {"nui": ["N0000175498", "M0017172"], "upc": ["0055154431453"], "unii": ["BDF1O1C72E"], "rxcui": ["312055"], "spl_set_id": ["56aca0e2-8691-4701-beba-e2315524709f"], "pharm_class_cs": ["Polyenes [CS]"], "pharm_class_epc": ["Polyene Antifungal [EPC]"], "manufacturer_name": ["Cardinal Health 107, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "5 CUP, UNIT-DOSE in 1 BAG (55154-4314-5)  / 5 mL in 1 CUP, UNIT-DOSE", "package_ndc": "55154-4314-5", "marketing_start_date": "20230801"}], "brand_name": "Nystatin", "product_id": "55154-4314_c6dbde35-e0a0-4f55-be3e-471aeb0b0302", "dosage_form": "SUSPENSION", "pharm_class": ["Polyene Antifungal [EPC]", "Polyenes [CS]"], "product_ndc": "55154-4314", "generic_name": "NYSTATIN", "labeler_name": "Cardinal Health 107, LLC", "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"}