nystatin

Generic: nystatin

Labeler: chartwell governmental & specialty rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name nystatin
Generic Name nystatin
Labeler chartwell governmental & specialty rx, llc
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

nystatin 100000 U/mL

Manufacturer
Chartwell Governmental & Specialty RX, LLC

Identifiers & Regulatory

Product NDC 68999-813
Product ID 68999-813_4369e33a-8ee4-2c6b-e063-6394a90aabcb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA050299
Listing Expiration 2026-12-31
Marketing Start 1971-04-14

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68999813
Hyphenated Format 68999-813

Supplemental Identifiers

RxCUI
312055
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 NDA050299 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100000 U/mL
source: ndc
Packaging
  • 2 TRAY in 1 BOX (68999-813-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-813-05)
source: ndc

Packages (1)

68999-813-24 2 TRAY in 1 BOX (68999-813-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-813-05)

Ingredients (1)

nystatin (100000 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": "4369e33a-8ee4-2c6b-e063-6394a90aabcb", "openfda": {"nui": ["N0000175498", "M0017172"], "unii": ["BDF1O1C72E"], "rxcui": ["312055"], "spl_set_id": ["88a0a22e-8d6b-42aa-b225-2d57fb5b3a97"], "pharm_class_cs": ["Polyenes [CS]"], "pharm_class_epc": ["Polyene Antifungal [EPC]"], "manufacturer_name": ["Chartwell Governmental & Specialty RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 TRAY in 1 BOX (68999-813-24)  / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-813-05)", "package_ndc": "68999-813-24", "marketing_start_date": "20251107"}], "brand_name": "Nystatin", "product_id": "68999-813_4369e33a-8ee4-2c6b-e063-6394a90aabcb", "dosage_form": "SUSPENSION", "pharm_class": ["Polyene Antifungal [EPC]", "Polyenes [CS]"], "product_ndc": "68999-813", "generic_name": "Nystatin", "labeler_name": "Chartwell Governmental & Specialty RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nystatin", "active_ingredients": [{"name": "NYSTATIN", "strength": "100000 U/mL"}], "application_number": "NDA050299", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "19710414", "listing_expiration_date": "20261231"}