Nystatin Cream
Nystatin Cream USP
Approved
Approval ID
5a2b6fee-1437-0c3a-e053-2991aa0a3443
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 24, 2023
Manufacturers
FDA
Crown Laboratories
DUNS: 079035945
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Nystatin Cream
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0316-0221
Application NumberANDA207733
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nystatin Cream
Product Specifications
Route of AdministrationTOPICAL
Effective DateOctober 24, 2023
FDA Product Classification
INGREDIENTS (8)
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
SORBIC ACIDInactive
Code: X045WJ989B
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4
Classification: IACT
CETYL PALMITATEInactive
Code: 5ZA2S6B08X
Classification: IACT
NYSTATINActive
Quantity: 100000 [USP'U] in 1 g
Code: BDF1O1C72E
Classification: ACTIB