nystatin

Generic: nystatin

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

Drug Facts

Product Profile

Brand Name nystatin
Generic Name nystatin
Labeler zydus pharmaceuticals usa inc.
Dosage Form POWDER
Routes
TOPICAL
Active Ingredients

nystatin 100000 [USP'U]/g

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 68382-370
Product ID 68382-370_7f7aaf27-0265-40b9-a900-341232347fad
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208581
Listing Expiration 2026-12-31
Marketing Start 2021-10-06

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68382370
Hyphenated Format 68382-370

Supplemental Identifiers

RxCUI
646456
UPC
0368382370037 0368382370013 0368382370020
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 ANDA208581 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 100000 [USP'U]/g
source: ndc
Packaging
  • 15 g in 1 BOTTLE, PLASTIC (68382-370-01)
  • 30 g in 1 BOTTLE, PLASTIC (68382-370-02)
  • 60 g in 1 BOTTLE, PLASTIC (68382-370-03)
source: ndc

Packages (3)

68382-370-01 15 g in 1 BOTTLE, PLASTIC (68382-370-01) 68382-370-02 30 g in 1 BOTTLE, PLASTIC (68382-370-02) 68382-370-03 60 g in 1 BOTTLE, PLASTIC (68382-370-03)

Ingredients (1)

nystatin (100000 [USP'U]/g)

Linked Drug Pages (1)

NYSTATIN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "7f7aaf27-0265-40b9-a900-341232347fad", "openfda": {"nui": ["N0000175498", "M0017172"], "upc": ["0368382370037", "0368382370013", "0368382370020"], "unii": ["BDF1O1C72E"], "rxcui": ["646456"], "spl_set_id": ["2daf159d-6a12-4b5d-97b3-8069c17e7635"], "pharm_class_cs": ["Polyenes [CS]"], "pharm_class_epc": ["Polyene Antifungal [EPC]"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "15 g in 1 BOTTLE, PLASTIC (68382-370-01)", "package_ndc": "68382-370-01", "marketing_start_date": "20211006"}, {"sample": false, "description": "30 g in 1 BOTTLE, PLASTIC (68382-370-02)", "package_ndc": "68382-370-02", "marketing_start_date": "20211006"}, {"sample": false, "description": "60 g in 1 BOTTLE, PLASTIC (68382-370-03)", "package_ndc": "68382-370-03", "marketing_start_date": "20211006"}], "brand_name": "NYSTATIN", "product_id": "68382-370_7f7aaf27-0265-40b9-a900-341232347fad", "dosage_form": "POWDER", "pharm_class": ["Polyene Antifungal [EPC]", "Polyenes [CS]"], "product_ndc": "68382-370", "generic_name": "nystatin", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NYSTATIN", "active_ingredients": [{"name": "NYSTATIN", "strength": "100000 [USP'U]/g"}], "application_number": "ANDA208581", "marketing_category": "ANDA", "marketing_start_date": "20211006", "listing_expiration_date": "20261231"}