"0116-4026-50" National Drug Code (NDC)

Nystatin Oral Suspension 5 TRAY in 1 CASE (0116-4026-50) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0116-4026-05)
(Xttrium Laboratories, Inc.)

NDC Code0116-4026-50
Package Description5 TRAY in 1 CASE (0116-4026-50) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0116-4026-05)
Product NDC0116-4026
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameNystatin Oral Suspension
Non-Proprietary NameNystatin
Dosage FormSUSPENSION
UsageORAL
Start Marketing Date20260206
Marketing Category NameANDA
Application NumberANDA062512
ManufacturerXttrium Laboratories, Inc.
Substance NameNYSTATIN
Strength100000
Strength Unit[USP'U]/mL
Pharmacy ClassesPolyene Antifungal [EPC], Polyenes [CS]

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