nystatin

Generic: nystatin

Labeler: redpharm drug, inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nystatin
Generic Name nystatin
Labeler redpharm drug, inc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

nystatin 100000 U/g

Manufacturer
RedPharm Drug, Inc

Identifiers & Regulatory

Product NDC 67296-1519
Product ID 67296-1519_4922a3ab-05b8-2ff2-e063-6294a90a9fd4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212557
Listing Expiration 2027-12-31
Marketing Start 2019-07-24

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 672961519
Hyphenated Format 67296-1519

Supplemental Identifiers

RxCUI
543546
UNII
BDF1O1C72E
NUI
N0000175498 M0017172

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 ANDA212557 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 100000 U/g
source: ndc
Packaging
  • 15 g in 1 TUBE (67296-1519-1)
  • 30 g in 1 TUBE (67296-1519-3)
source: ndc

Packages (2)

67296-1519-1 15 g in 1 TUBE (67296-1519-1) 67296-1519-3 30 g in 1 TUBE (67296-1519-3)

Ingredients (1)

nystatin (100000 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": "4922a3ab-05b8-2ff2-e063-6294a90a9fd4", "openfda": {"nui": ["N0000175498", "M0017172"], "unii": ["BDF1O1C72E"], "rxcui": ["543546"], "spl_set_id": ["f4c298d5-b012-7b56-e053-2a95a90a3d55"], "pharm_class_cs": ["Polyenes [CS]"], "pharm_class_epc": ["Polyene Antifungal [EPC]"], "manufacturer_name": ["RedPharm Drug, Inc"]}, "finished": true, "packaging": [{"sample": false, "description": "15 g in 1 TUBE (67296-1519-1)", "package_ndc": "67296-1519-1", "marketing_start_date": "20190724"}, {"sample": false, "description": "30 g in 1 TUBE (67296-1519-3)", "package_ndc": "67296-1519-3", "marketing_start_date": "20190724"}], "brand_name": "Nystatin", "product_id": "67296-1519_4922a3ab-05b8-2ff2-e063-6294a90a9fd4", "dosage_form": "CREAM", "pharm_class": ["Polyene Antifungal [EPC]", "Polyenes [CS]"], "product_ndc": "67296-1519", "generic_name": "Nystatin", "labeler_name": "RedPharm Drug, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nystatin", "active_ingredients": [{"name": "NYSTATIN", "strength": "100000 U/g"}], "application_number": "ANDA212557", "marketing_category": "ANDA", "marketing_start_date": "20190724", "listing_expiration_date": "20271231"}