NDC 0378-5300

Nizatidine

Nizatidine

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

• Product ID: 0378-5300_1510df83-b013-4280-b49b-d0d2a23e86d4
• NDC: 0378-5300
• Product Type: Human Prescription Drug
• Proprietary Name: Nizatidine
• Generic Name: Nizatidine
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2002-07-10
• Marketing End Date: 2020-08-31
• Marketing Category: ANDA / ANDA
• Application Number: ANDA075806
• Labeler Name: Mylan Pharmaceuticals Inc.
• Substance Name: NIZATIDINE
• Active Ingredient Strength: 300 mg/1
• Pharm Classes: Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]
• NDC Exclude Flag: N

Packaging

NDC 0378-5300-93

30 CAPSULE in 1 BOTTLE, PLASTIC (0378-5300-93)

• Marketing Start Date: 2002-07-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0378-5300-93 [00378530093]

Nizatidine CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA075806
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2002-07-10
• Marketing End Date: 2020-08-31

NDC 0378-5300-01 [00378530001]

Nizatidine CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA075806
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2002-07-10
• Marketing End Date: 2014-02-28

Drug Details

Active Ingredients

Ingredient	Strength
NIZATIDINE	300 mg/1

OpenFDA Data

• SPL SET ID: db844934-9c1d-4576-a1b5-ef9b9c66a940
• Manufacturer:
  • Mylan Pharmaceuticals Inc.
• UNII:
  • P41PML4GHR
• RxNorm Concept Unique ID - RxCUI:
  • 198041
  • 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