Nystatin

Generic: Nystatin

Labeler: Chartwell RX, LLC
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Active

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

Identifiers & Regulatory

Product NDC 62135-813
Product ID 62135-813_4988faa3-12b2-4524-e063-6294a90ae7fb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA050299
Listing Expiration 2027-12-31
Marketing Start 1971-04-14

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62135813
Hyphenated Format 62135-813

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 (62135-813-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-813-05)
  • 60 mL in 1 BOTTLE (62135-813-46)
  • 473 mL in 1 BOTTLE (62135-813-47)
source: ndc

Packages (3)

62135-813-24 2 TRAY in 1 BOX (62135-813-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-813-05) 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": "4988faa3-12b2-4524-e063-6294a90ae7fb", "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": "2 TRAY in 1 BOX (62135-813-24)  / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-813-05)", "package_ndc": "62135-813-24", "marketing_start_date": "20241022"}, {"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_4988faa3-12b2-4524-e063-6294a90ae7fb", "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"}