"0378-3340-53" National Drug Code (NDC)

Xulane 3 POUCH in 1 CARTON (0378-3340-53) > 1 PATCH in 1 POUCH (0378-3340-16) > 7 d in 1 PATCH
(Mylan Pharmaceuticals Inc.)

NDC Code0378-3340-53
Package Description3 POUCH in 1 CARTON (0378-3340-53) > 1 PATCH in 1 POUCH (0378-3340-16) > 7 d in 1 PATCH
Product NDC0378-3340
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameXulane
Non-Proprietary NameNorelgestromin And Ethinyl Estradiol
Dosage FormPATCH
UsageTRANSDERMAL
Start Marketing Date20140416
Marketing Category NameANDA
Application NumberANDA200910
ManufacturerMylan Pharmaceuticals Inc.
Substance NameETHINYL ESTRADIOL; NORELGESTROMIN
Strength35; 150
Strength Unitug/d; ug/d
Pharmacy ClassesEstrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]

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