"0378-7518-35" National Drug Code (NDC)

Difluprednate 1 BOTTLE in 1 CARTON (0378-7518-35) / 5 mL in 1 BOTTLE
(Mylan Pharmaceuticals Inc.)

NDC Code0378-7518-35
Package Description1 BOTTLE in 1 CARTON (0378-7518-35) / 5 mL in 1 BOTTLE
Product NDC0378-7518
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameDifluprednate
Non-Proprietary NameDifluprednate
Dosage FormEMULSION
UsageOPHTHALMIC
Start Marketing Date20250926
Marketing Category NameANDA
Application NumberANDA212566
ManufacturerMylan Pharmaceuticals Inc.
Substance NameDIFLUPREDNATE
Strength.5
Strength Unitmg/mL

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