"50419-422-08" National Drug Code (NDC)

Skyla 1 INTRAUTERINE DEVICE in 1 CARTON (50419-422-08)
(Bayer HealthCare Pharmaceuticals Inc.)

NDC Code50419-422-08
Package Description1 INTRAUTERINE DEVICE in 1 CARTON (50419-422-08)
Product NDC50419-422
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameSkyla
Non-Proprietary NameLevonorgestrel
Dosage FormINTRAUTERINE DEVICE
UsageINTRAUTERINE
Start Marketing Date20130111
Marketing Category NameNDA
Application NumberNDA203159
ManufacturerBayer HealthCare Pharmaceuticals Inc.
Substance NameLEVONORGESTREL
Strength13.5
Strength Unitmg/1
Pharmacy ClassesInhibit Ovum Fertilization [PE], Progesterone Congeners [CS], Progesterone Congeners [CS], Progestin [EPC], Progestin-containing Intrauterine Device [EPC]

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