nyamyc

Generic: nystatin

Labeler: upsher-smith laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nyamyc
Generic Name nystatin
Labeler upsher-smith laboratories, llc
Dosage Form POWDER
Routes
TOPICAL
Active Ingredients

nystatin 100000 [USP'U]/g

Manufacturer
Upsher-Smith Laboratories, LLC

Identifiers & Regulatory

Product NDC 0832-0465
Product ID 0832-0465_3984f88f-d61f-1fa9-e063-6394a90acb11
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065183
Listing Expiration 2026-12-31
Marketing Start 2005-05-03

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 08320465
Hyphenated Format 0832-0465

Supplemental Identifiers

RxCUI
584414 646456
UPC
0308320465159
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 nyamyc (source: ndc)
Generic Name nystatin (source: ndc)
Application Number ANDA065183 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 100000 [USP'U]/g
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (0832-0465-15) / 15 g in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 CARTON (0832-0465-30) / 30 g in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 CARTON (0832-0465-60) / 60 g in 1 BOTTLE, PLASTIC
source: ndc

Packages (3)

0832-0465-15 1 BOTTLE, PLASTIC in 1 CARTON (0832-0465-15) / 15 g in 1 BOTTLE, PLASTIC 0832-0465-30 1 BOTTLE, PLASTIC in 1 CARTON (0832-0465-30) / 30 g in 1 BOTTLE, PLASTIC 0832-0465-60 1 BOTTLE, PLASTIC in 1 CARTON (0832-0465-60) / 60 g in 1 BOTTLE, PLASTIC

Ingredients (1)

nystatin (100000 [USP'U]/g)

Linked Drug Pages (1)

Nyamyc ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "3984f88f-d61f-1fa9-e063-6394a90acb11", "openfda": {"nui": ["N0000175498", "M0017172"], "upc": ["0308320465159"], "unii": ["BDF1O1C72E"], "rxcui": ["584414", "646456"], "spl_set_id": ["01b44f91-9b68-464a-9693-b5d3e793bf3c"], "pharm_class_cs": ["Polyenes [CS]"], "pharm_class_epc": ["Polyene Antifungal [EPC]"], "manufacturer_name": ["Upsher-Smith Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (0832-0465-15)  / 15 g in 1 BOTTLE, PLASTIC", "package_ndc": "0832-0465-15", "marketing_start_date": "20050503"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (0832-0465-30)  / 30 g in 1 BOTTLE, PLASTIC", "package_ndc": "0832-0465-30", "marketing_start_date": "20050503"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (0832-0465-60)  / 60 g in 1 BOTTLE, PLASTIC", "package_ndc": "0832-0465-60", "marketing_start_date": "20120309"}], "brand_name": "Nyamyc", "product_id": "0832-0465_3984f88f-d61f-1fa9-e063-6394a90acb11", "dosage_form": "POWDER", "pharm_class": ["Polyene Antifungal [EPC]", "Polyenes [CS]"], "product_ndc": "0832-0465", "generic_name": "Nystatin", "labeler_name": "Upsher-Smith Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nyamyc", "active_ingredients": [{"name": "NYSTATIN", "strength": "100000 [USP'U]/g"}], "application_number": "ANDA065183", "marketing_category": "ANDA", "marketing_start_date": "20050503", "listing_expiration_date": "20261231"}