Nystatin
NYSTATIN CREAM USP DRUG FACTS
Approved
Approval ID
86cfb84c-dcd3-b229-e053-2a91aa0aed5c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 11, 2021
Manufacturers
FDA
NuCare Pharmaceuticals,Inc.
DUNS: 010632300
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Nystatin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code66267-953
Application NumberANDA062225
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nystatin
Product Specifications
Route of AdministrationTOPICAL
Effective DateJanuary 11, 2021
FDA Product Classification
INGREDIENTS (7)
LACTIC ACID, UNSPECIFIED FORMInactive
Code: 33X04XA5AT
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJS
Classification: IACT
SORBIC ACIDInactive
Code: X045WJ989B
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
NYSTATINActive
Quantity: 100000 [USP'U] in 1 g
Code: BDF1O1C72E
Classification: ACTIB
Drug Labeling Information
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 8/25/2015
Manufactured By Perrigo
Bronx, NY 10457
Distributed By Perrigo
Allegan, MI 49010 • www.perrigo.com
Rev. 07-15
: 1P600 RC JX1