nystatin

Generic: nystatin

Labeler: teva pharmaceuticals usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nystatin
Generic Name nystatin
Labeler teva pharmaceuticals usa, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

nystatin 500000 [USP'U]/1

Manufacturer
Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 0093-0983
Product ID 0093-0983_b55205c3-f0be-44eb-a267-3af07c1639f4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA062506
Listing Expiration 2026-12-31
Marketing Start 1990-09-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00930983
Hyphenated Format 0093-0983

Supplemental Identifiers

RxCUI
312059
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 ANDA062506 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500000 [USP'U]/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (0093-0983-01)
source: ndc

Packages (1)

0093-0983-01 100 TABLET, FILM COATED in 1 BOTTLE (0093-0983-01)

Ingredients (1)

nystatin (500000 [USP'U]/1)

Linked Drug Pages (1)

Nystatin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b55205c3-f0be-44eb-a267-3af07c1639f4", "openfda": {"nui": ["N0000175498", "M0017172"], "unii": ["BDF1O1C72E"], "rxcui": ["312059"], "spl_set_id": ["f03b294d-10cd-4bba-92c8-42ae9b110cd0"], "pharm_class_cs": ["Polyenes [CS]"], "pharm_class_epc": ["Polyene Antifungal [EPC]"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (0093-0983-01)", "package_ndc": "0093-0983-01", "marketing_start_date": "19900930"}], "brand_name": "Nystatin", "product_id": "0093-0983_b55205c3-f0be-44eb-a267-3af07c1639f4", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Polyene Antifungal [EPC]", "Polyenes [CS]"], "product_ndc": "0093-0983", "generic_name": "Nystatin", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nystatin", "active_ingredients": [{"name": "NYSTATIN", "strength": "500000 [USP'U]/1"}], "application_number": "ANDA062506", "marketing_category": "ANDA", "marketing_start_date": "19900930", "listing_expiration_date": "20261231"}