nystatin

Generic: nystatin

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

Drug Facts

Product Profile

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

nystatin 100000 U/mL

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-813
Product ID 62135-813_4c47b825-6b93-307f-e063-6394a90a2b7d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA050299
Listing Expiration 2027-12-31
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 62135813
Hyphenated Format 62135-813

Supplemental Identifiers

RxCUI
312055
UPC
0362135813475 0362135813468
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
  • 60 mL in 1 BOTTLE (62135-813-46)
  • 473 mL in 1 BOTTLE (62135-813-47)
source: ndc

Packages (2)

62135-813-46 60 mL in 1 BOTTLE (62135-813-46) 62135-813-47 473 mL in 1 BOTTLE (62135-813-47)

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": "4c47b825-6b93-307f-e063-6394a90a2b7d", "openfda": {"nui": ["N0000175498", "M0017172"], "upc": ["0362135813475", "0362135813468"], "unii": ["BDF1O1C72E"], "rxcui": ["312055"], "spl_set_id": ["9954118e-abe6-4388-98c9-4473d39b2e28"], "pharm_class_cs": ["Polyenes [CS]"], "pharm_class_epc": ["Polyene Antifungal [EPC]"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 mL in 1 BOTTLE (62135-813-46)", "package_ndc": "62135-813-46", "marketing_start_date": "20240627"}, {"sample": false, "description": "473 mL in 1 BOTTLE (62135-813-47)", "package_ndc": "62135-813-47", "marketing_start_date": "20240410"}], "brand_name": "Nystatin", "product_id": "62135-813_4c47b825-6b93-307f-e063-6394a90a2b7d", "dosage_form": "SUSPENSION", "pharm_class": ["Polyene Antifungal [EPC]", "Polyenes [CS]"], "product_ndc": "62135-813", "generic_name": "Nystatin", "labeler_name": "Chartwell 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": "20271231"}