Nizatidine - 0378-5300-01 - (nizatidine)

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Drug Information of Nizatidine

Product NDC: 0378-5300
Proprietary Name: Nizatidine
Non Proprietary Name: nizatidine
Active Ingredient(s): 300    mg/1 & nbsp;   nizatidine
Administration Route(s): ORAL
Dosage Form(s): CAPSULE
Coding System: National Drug Codes(NDC)

Labeler Information of Nizatidine

Product NDC: 0378-5300
Labeler Name: Mylan Pharmaceuticals Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA075806
Marketing Category: ANDA
Start Marketing Date: 20110506

Package Information of Nizatidine

Package NDC: 0378-5300-01
Package Description: 100 CAPSULE in 1 BOTTLE, PLASTIC (0378-5300-01)

NDC Information of Nizatidine

NDC Code 0378-5300-01
Proprietary Name Nizatidine
Package Description 100 CAPSULE in 1 BOTTLE, PLASTIC (0378-5300-01)
Product NDC 0378-5300
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name nizatidine
Dosage Form Name CAPSULE
Route Name ORAL
Start Marketing Date 20110506
Marketing Category Name ANDA
Labeler Name Mylan Pharmaceuticals Inc.
Substance Name NIZATIDINE
Strength Number 300
Strength Unit mg/1
Pharmaceutical Classes Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]

Complete Information of Nizatidine


General Information