NDC 0178-8500

Tindamax

Tinidazole

Tindamax is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Mission Pharmacal Company. The primary component is Tinidazole.

• Product ID: 0178-8500_7c5ce3bc-8d44-de44-e053-2991aa0a0abf
• NDC: 0178-8500
• Product Type: Human Prescription Drug
• Proprietary Name: Tindamax
• Generic Name: Tinidazole
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2004-05-17
• Marketing Category: NDA / NDA
• Application Number: NDA021618
• Labeler Name: Mission Pharmacal Company
• Substance Name: TINIDAZOLE
• Active Ingredient Strength: 500 mg/1
• Pharm Classes: Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0178-8500-20

20 TABLET, FILM COATED in 1 BOTTLE (0178-8500-20)

• Marketing Start Date: 2004-05-17
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0178-8500-20 [00178850020]

Tindamax TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA021618
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2004-05-17
• Inactivation Date: 2020-01-31

NDC 0178-8500-04 [00178850004]

Tindamax TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA021618
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2004-05-17
• Marketing End Date: 2012-12-31
• Inactivation Date: 2020-01-31

NDC 0178-8500-60 [00178850060]

Tindamax TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA021618
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2004-05-17
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
TINIDAZOLE	500 mg/1

OpenFDA Data

• SPL SET ID: a0d01539-8413-4703-94cc-d221918630a1
• Manufacturer:
  • Mission Pharmacal Company
• UNII:
  • 033KF7V46H
• RxNorm Concept Unique ID - RxCUI:
  • 539809
  • 539811
  • 477234
  • 199519

Pharmacological Class

• Nitroimidazole Antimicrobial [EPC]
• Nitroimidazoles [CS]

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

NDC	Brand Name	Generic Name
0178-8250	Tindamax	tinidazole
0178-8500	Tindamax	tinidazole
16571-214	Tindazole	Tinidazole
16571-215	Tindazole	Tinidazole
64980-426	Tindazole	Tinidazole
64980-427	Tindazole	Tinidazole
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