nystatin

Generic: nystatin

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nystatin
Generic Name nystatin
Labeler proficient rx lp
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

nystatin 100000 [USP'U]/g

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 63187-703
Product ID 63187-703_bbcffae3-b609-478f-9702-6ae78847cdba
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA064022
Listing Expiration 2026-12-31
Marketing Start 1993-01-28

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63187703
Hyphenated Format 63187-703

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 ANDA064022 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 100000 [USP'U]/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (63187-703-15) / 15 g in 1 TUBE
  • 1 TUBE in 1 CARTON (63187-703-30) / 30 g in 1 TUBE
source: ndc

Packages (2)

63187-703-15 1 TUBE in 1 CARTON (63187-703-15) / 15 g in 1 TUBE 63187-703-30 1 TUBE in 1 CARTON (63187-703-30) / 30 g in 1 TUBE

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": "bbcffae3-b609-478f-9702-6ae78847cdba", "openfda": {"nui": ["N0000175498", "M0017172"], "unii": ["BDF1O1C72E"], "rxcui": ["543546"], "spl_set_id": ["5ef15e1c-66dc-4858-8552-d83e42c3883e"], "pharm_class_cs": ["Polyenes [CS]"], "pharm_class_epc": ["Polyene Antifungal [EPC]"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (63187-703-15)  / 15 g in 1 TUBE", "package_ndc": "63187-703-15", "marketing_start_date": "20160601"}, {"sample": false, "description": "1 TUBE in 1 CARTON (63187-703-30)  / 30 g in 1 TUBE", "package_ndc": "63187-703-30", "marketing_start_date": "20160601"}], "brand_name": "Nystatin", "product_id": "63187-703_bbcffae3-b609-478f-9702-6ae78847cdba", "dosage_form": "CREAM", "pharm_class": ["Polyene Antifungal [EPC]", "Polyenes [CS]"], "product_ndc": "63187-703", "generic_name": "Nystatin", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nystatin", "active_ingredients": [{"name": "NYSTATIN", "strength": "100000 [USP'U]/g"}], "application_number": "ANDA064022", "marketing_category": "ANDA", "marketing_start_date": "19930128", "listing_expiration_date": "20261231"}