nystatin

Generic: nystatin

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nystatin
Generic Name nystatin
Labeler a-s medication solutions
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

nystatin 100000 [USP'U]/mL

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-5315
Product ID 50090-5315_7b3059b0-402b-4cea-88c4-5e7e787a34e7
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 500905315
Hyphenated Format 50090-5315

Supplemental Identifiers

RxCUI
312055
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
  • 60 mL in 1 BOTTLE, DROPPER (50090-5315-0)
source: ndc

Packages (1)

50090-5315-0 60 mL in 1 BOTTLE, DROPPER (50090-5315-0)

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": "7b3059b0-402b-4cea-88c4-5e7e787a34e7", "openfda": {"nui": ["N0000175498", "M0017172"], "unii": ["BDF1O1C72E"], "rxcui": ["312055"], "spl_set_id": ["cc3516cd-985c-489f-b4a1-8477876c5a97"], "pharm_class_cs": ["Polyenes [CS]"], "pharm_class_epc": ["Polyene Antifungal [EPC]"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "60 mL in 1 BOTTLE, DROPPER (50090-5315-0)", "package_ndc": "50090-5315-0", "marketing_start_date": "20201029"}], "brand_name": "Nystatin", "product_id": "50090-5315_7b3059b0-402b-4cea-88c4-5e7e787a34e7", "dosage_form": "SUSPENSION", "pharm_class": ["Polyene Antifungal [EPC]", "Polyenes [CS]"], "product_ndc": "50090-5315", "generic_name": "NYSTATIN", "labeler_name": "A-S Medication Solutions", "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"}