NDC 0378-0551

Tolazamide

Tolazamide

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

• Product ID: 0378-0551_3c311244-cd9b-47ce-8cbd-9b4019bdb7d3
• NDC: 0378-0551
• Product Type: Human Prescription Drug
• Proprietary Name: Tolazamide
• Generic Name: Tolazamide
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2013-01-18
• Marketing End Date: 2020-03-31
• Marketing Category: ANDA / ANDA
• Application Number: ANDA070259
• Labeler Name: Mylan Pharmaceuticals Inc.
• Substance Name: TOLAZAMIDE
• Active Ingredient Strength: 500 mg/1
• Pharm Classes: Sulfonylurea [EPC],Sulfonylurea Compounds [CS]
• NDC Exclude Flag: N

Packaging

NDC 0378-0551-01

100 TABLET in 1 BOTTLE, PLASTIC (0378-0551-01)

• Marketing Start Date: 2013-01-18
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0378-0551-01 [00378055101]

Tolazamide TABLET

• Marketing Category: ANDA
• Application Number: ANDA070259
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2013-01-18
• Marketing End Date: 2020-03-31

Drug Details

Active Ingredients

Ingredient	Strength
TOLAZAMIDE	500 mg/1

OpenFDA Data

• SPL SET ID: 5cde1f9b-74f6-6c03-6329-20969b6f1cbb
• Manufacturer:
  • Mylan Pharmaceuticals Inc.
• UNII:
  • 9LT1BRO48Q
• RxNorm Concept Unique ID - RxCUI:
  • 198293
  • 198292

Pharmacological Class

• Sulfonylurea [EPC]
• Sulfonylurea Compounds [CS]

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

NDC	Brand Name	Generic Name
0378-0217	Tolazamide	tolazamide
0378-0551	Tolazamide	tolazamide
55289-265	Tolazamide	tolazamide