nystatin

Generic: nystatin

Labeler: taro pharmaceuticals u.s.a., inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nystatin
Generic Name nystatin
Labeler taro pharmaceuticals u.s.a., inc.
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

nystatin 100000 [USP'U]/mL

Manufacturer
Taro Pharmaceuticals U.S.A., Inc.

Identifiers & Regulatory

Product NDC 51672-4117
Product ID 51672-4117_29a58f9e-6262-8297-e063-6294a90ad86d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA062876
Listing Expiration 2026-12-31
Marketing Start 1988-02-29

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 516724117
Hyphenated Format 51672-4117

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 ANDA062876 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100000 [USP'U]/mL
source: ndc
Packaging
  • 3785 mL in 1 BOTTLE (51672-4117-0)
  • 1 BOTTLE, DROPPER in 1 CARTON (51672-4117-4) / 60 mL in 1 BOTTLE, DROPPER
  • 473 mL in 1 BOTTLE (51672-4117-9)
source: ndc

Packages (3)

51672-4117-0 3785 mL in 1 BOTTLE (51672-4117-0) 51672-4117-4 1 BOTTLE, DROPPER in 1 CARTON (51672-4117-4) / 60 mL in 1 BOTTLE, DROPPER 51672-4117-9 473 mL in 1 BOTTLE (51672-4117-9)

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": "29a58f9e-6262-8297-e063-6294a90ad86d", "openfda": {"nui": ["N0000175498", "M0017172"], "unii": ["BDF1O1C72E"], "rxcui": ["312055"], "spl_set_id": ["01c469b3-ec10-452c-8c02-3e7d22e40297"], "pharm_class_cs": ["Polyenes [CS]"], "pharm_class_epc": ["Polyene Antifungal [EPC]"], "manufacturer_name": ["Taro Pharmaceuticals U.S.A., Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3785 mL in 1 BOTTLE (51672-4117-0)", "package_ndc": "51672-4117-0", "marketing_start_date": "19880229"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (51672-4117-4)  / 60 mL in 1 BOTTLE, DROPPER", "package_ndc": "51672-4117-4", "marketing_start_date": "19880229"}, {"sample": false, "description": "473 mL in 1 BOTTLE (51672-4117-9)", "package_ndc": "51672-4117-9", "marketing_start_date": "19880229"}], "brand_name": "Nystatin", "product_id": "51672-4117_29a58f9e-6262-8297-e063-6294a90ad86d", "dosage_form": "SUSPENSION", "pharm_class": ["Polyene Antifungal [EPC]", "Polyenes [CS]"], "product_ndc": "51672-4117", "generic_name": "Nystatin", "labeler_name": "Taro Pharmaceuticals U.S.A., Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nystatin", "active_ingredients": [{"name": "NYSTATIN", "strength": "100000 [USP'U]/mL"}], "application_number": "ANDA062876", "marketing_category": "ANDA", "marketing_start_date": "19880229", "listing_expiration_date": "20261231"}