"0378-7294-53" National Drug Code (NDC)

Estradiol And Norethindrone Acetate 3 POUCH in 1 CARTON (0378-7294-53) / 1 BLISTER PACK in 1 POUCH (0378-7294-85) / 28 TABLET in 1 BLISTER PACK
(Mylan Pharmaceuticals Inc.)

NDC Code0378-7294-53
Package Description3 POUCH in 1 CARTON (0378-7294-53) / 1 BLISTER PACK in 1 POUCH (0378-7294-85) / 28 TABLET in 1 BLISTER PACK
Product NDC0378-7294
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameEstradiol And Norethindrone Acetate
Non-Proprietary NameEstradiol And Norethindrone Acetate
Dosage FormTABLET
UsageORAL
Start Marketing Date20180724
Marketing Category NameANDA
Application NumberANDA207261
ManufacturerMylan Pharmaceuticals Inc.
Substance NameESTRADIOL; NORETHINDRONE ACETATE
Strength.5; .1
Strength Unitmg/1; mg/1
Pharmacy ClassesEstradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]

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