NDC 40032-551

Tinidazole

Tinidazole

Tinidazole is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Novel Laboratories, Inc.. The primary component is Tinidazole.

• Product ID: 40032-551_530af487-7e0b-4ad5-a45b-3f7d9b1b71ae
• NDC: 40032-551
• Product Type: Human Prescription Drug
• Proprietary Name: Tinidazole
• Generic Name: Tinidazole
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2012-04-30
• Marketing Category: ANDA / ANDA
• Application Number: ANDA202044
• Labeler Name: Novel Laboratories, Inc.
• Substance Name: TINIDAZOLE
• Active Ingredient Strength: 500 mg/1
• Pharm Classes: Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS]
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 40032-551-20

20 TABLET in 1 BOTTLE (40032-551-20)

• Marketing Start Date: 2012-04-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 40032-551-60 [40032055160]

Tinidazole TABLET

• Marketing Category: ANDA
• Application Number: ANDA202044
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2012-04-30
• Inactivation Date: 2020-01-31

NDC 40032-551-20 [40032055120]

Tinidazole TABLET

• Marketing Category: ANDA
• Application Number: ANDA202044
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2012-04-30
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
TINIDAZOLE	500 mg/1

OpenFDA Data

• SPL SET ID: 4e03b4ac-c88a-4044-9d58-0cfcda3db53c
• Manufacturer:
  • Novel Laboratories, Inc.
• UNII:
  • 033KF7V46H
• RxNorm Concept Unique ID - RxCUI:
  • 477234
  • 199519

Pharmacological Class

• Nitroimidazole Antimicrobial [EPC]
• Nitroimidazoles [CS]

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

NDC	Brand Name	Generic Name
0054-0347	Tinidazole	Tinidazole
0054-0348	Tinidazole	Tinidazole
40032-550	Tinidazole	Tinidazole
40032-551	Tinidazole	Tinidazole
42799-207	Tinidazole	Tinidazole
42799-208	Tinidazole	Tinidazole
43386-550	Tinidazole	Tinidazole
43386-551	Tinidazole	Tinidazole
44523-425	Tinidazole	Tinidazole
44523-450	Tinidazole	Tinidazole
53002-1611	Tinidazole	Tinidazole
63629-8386	Tinidazole	Tinidazole
67296-1729	Tinidazole	Tinidazole
0178-8250	Tindamax	tinidazole
0178-8500	Tindamax	tinidazole
16571-214	Tindazole	Tinidazole
16571-215	Tindazole	Tinidazole
64980-426	Tindazole	Tinidazole
64980-427	Tindazole	Tinidazole