"0378-5300-01" National Drug Code (NDC)

Nizatidine 100 CAPSULE in 1 BOTTLE, PLASTIC (0378-5300-01)
(Mylan Pharmaceuticals Inc.)

NDC Code0378-5300-01
Package Description100 CAPSULE in 1 BOTTLE, PLASTIC (0378-5300-01)
Product NDC0378-5300
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameNizatidine
Non-Proprietary NameNizatidine
Dosage FormCAPSULE
UsageORAL
Start Marketing Date20110506
Marketing Category NameANDA
Application NumberANDA075806
ManufacturerMylan Pharmaceuticals Inc.
Substance NameNIZATIDINE
Strength300
Strength Unitmg/1
Pharmacy ClassesHistamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]

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