nystatin

Generic: nystatin

Labeler: dr. reddy's labratories inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nystatin
Generic Name nystatin
Labeler dr. reddy's labratories inc.
Dosage Form POWDER
Routes
TOPICAL
Active Ingredients

nystatin 100000 [USP'U]/g

Manufacturer
Dr. Reddy's Labratories Inc.

Identifiers & Regulatory

Product NDC 75907-060
Product ID 75907-060_f635996b-25e1-c80b-32d0-eb75ee46a25f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065203
Listing Expiration 2026-12-31
Marketing Start 2024-05-28

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 75907060
Hyphenated Format 75907-060

Supplemental Identifiers

RxCUI
646456
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 ANDA065203 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 100000 [USP'U]/g
source: ndc
Packaging
  • 30 g in 1 BOTTLE, PLASTIC (75907-060-30)
  • 15 g in 1 BOTTLE, PLASTIC (75907-060-44)
  • 60 g in 1 BOTTLE, PLASTIC (75907-060-60)
source: ndc

Packages (3)

75907-060-30 30 g in 1 BOTTLE, PLASTIC (75907-060-30) 75907-060-44 15 g in 1 BOTTLE, PLASTIC (75907-060-44) 75907-060-60 60 g in 1 BOTTLE, PLASTIC (75907-060-60)

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": "f635996b-25e1-c80b-32d0-eb75ee46a25f", "openfda": {"nui": ["N0000175498", "M0017172"], "unii": ["BDF1O1C72E"], "rxcui": ["646456"], "spl_set_id": ["6bde84a1-341d-09ce-58b6-f9a653dc98c5"], "pharm_class_cs": ["Polyenes [CS]"], "pharm_class_epc": ["Polyene Antifungal [EPC]"], "manufacturer_name": ["Dr. Reddy's Labratories Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 g in 1 BOTTLE, PLASTIC (75907-060-30)", "package_ndc": "75907-060-30", "marketing_start_date": "20240528"}, {"sample": false, "description": "15 g in 1 BOTTLE, PLASTIC (75907-060-44)", "package_ndc": "75907-060-44", "marketing_start_date": "20240528"}, {"sample": false, "description": "60 g in 1 BOTTLE, PLASTIC (75907-060-60)", "package_ndc": "75907-060-60", "marketing_start_date": "20240528"}], "brand_name": "Nystatin", "product_id": "75907-060_f635996b-25e1-c80b-32d0-eb75ee46a25f", "dosage_form": "POWDER", "pharm_class": ["Polyene Antifungal [EPC]", "Polyenes [CS]"], "product_ndc": "75907-060", "generic_name": "Nystatin", "labeler_name": "Dr. Reddy's Labratories Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nystatin", "active_ingredients": [{"name": "NYSTATIN", "strength": "100000 [USP'U]/g"}], "application_number": "ANDA065203", "marketing_category": "ANDA", "marketing_start_date": "20240528", "listing_expiration_date": "20261231"}