NDC 45865-374

Nizatidine

Nizatidine

Nizatidine is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Medsource Pharmaceuticals. The primary component is Nizatidine.

• Product ID: 45865-374_1d6161e3-2dda-5446-e054-00144ff8d46c
• NDC: 45865-374
• Product Type: Human Prescription Drug
• Proprietary Name: Nizatidine
• Generic Name: Nizatidine
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2011-07-15
• Marketing Category: ANDA / ANDA
• Application Number: ANDA090618
• Labeler Name: Medsource Pharmaceuticals
• Substance Name: NIZATIDINE
• Active Ingredient Strength: 150 mg/1
• Pharm Classes: Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 45865-374-60

60 CAPSULE in 1 BOTTLE (45865-374-60)

• Marketing Start Date: 2011-07-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 45865-374-60 [45865037460]

Nizatidine CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA090618
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2011-07-15
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
NIZATIDINE	150 mg/1

OpenFDA Data

• SPL SET ID: 1d6161e3-2ddb-5446-e054-00144ff8d46c
• Manufacturer:
  • Medsource Pharmaceuticals
• UNII:
  • P41PML4GHR
• RxNorm Concept Unique ID - RxCUI:
  • 312025

Pharmacological Class

• Histamine H2 Receptor Antagonists [MoA]
• Histamine-2 Receptor Antagonist [EPC]

NDC Crossover Matching brand name "Nizatidine" or generic name "Nizatidine"

NDC	Brand Name	Generic Name
0185-0150	nizatidine	nizatidine
0185-0300	nizatidine	nizatidine
0378-5150	Nizatidine	nizatidine
0378-5300	Nizatidine	nizatidine
0591-3137	Nizatidine	Nizatidine
0591-3138	Nizatidine	Nizatidine
21695-043	Nizatidine	Nizatidine
21695-375	nizatidine	nizatidine
42254-093	Nizatidine	Nizatidine
45865-374	Nizatidine	Nizatidine
52959-824	Nizatidine	Nizatidine
55111-310	Nizatidine	Nizatidine
55111-311	Nizatidine	Nizatidine
60846-301	NIZATIDINE	NIZATIDINE
63187-249	Nizatidine	Nizatidine
63629-2769	Nizatidine	Nizatidine
65162-659	Nizatidine	Nizatidine
68071-1633	Nizatidine	Nizatidine
68071-5043	Nizatidine	Nizatidine
68151-0017	Nizatidine	Nizatidine
68258-3006	Nizatidine	Nizatidine
68462-425	Nizatidine	Nizatidine
68462-426	Nizatidine	Nizatidine
68788-8913	Nizatidine	Nizatidine
71335-0086	Nizatidine	Nizatidine