0054-0348 : Tinidazole 500 mg Oral Tablet


NDC: 0054-0348
Labeler: Roxane Laboratories, Inc
Product Type: Human Prescription Drug
Drug Name:  Tinidazole
Dosage Form: Oral Tablet, Film Coated
Application #: ANDA201172
Rev. Date: 


Appearance:


Markings: 54455
Shapes:  Oval
Colors:  White
Size (mm): 16
Segments: * 2

* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 2 indicates a scored pill which can be broken into 2 equal pieces.

54455: (0054-0348) Tinidazole 500 mg Oral Tablet by Roxane Laboratories, Inc
The above image is provided by the U.S. National Library of Medicine (NLM) and is not part of the official label.

NDC Package Codes:

  • 0054-0348-07: 20 TABLET, FILM COATED IN 1 BOTTLE (0054‑0348‑07)
  • 0054-0348-21: 60 TABLET, FILM COATED IN 1 BOTTLE (0054‑0348‑21)

Active Ingredients:

  • Tinidazole

Dosage Strength:

  • 500 mg

Inactive Ingredients:

  • Povidone K12
  • Cellulose, Microcrystalline
  • Croscarmellose Sodium
  • Silicon Dioxide
  • Magnesium Stearate
  • Water
  • Hypromelloses
  • Polyethylene Glycols
  • Polydextrose
  • Titanium Dioxide
  • Triacetin

Pharmaceutical Classes:

  • Nitroimidazole Antimicrobial [EPC]
  • Nitroimidazoles [Chemical/Ingredient]

Related Products:

Based on records with the same trade name.
  • 0054-0347 Tinidazole 250 mg Oral Tablet by Roxane Laboratories, Inc
  • 40032-550 Tinidazole 250 mg Oral Tablet by Novel Laboratories, Inc.
  • 40032-551 Tinidazole 500 mg Oral Tablet by Novel Laboratories, Inc.
  • 42799-207 Tinidazole 250 mg Oral Tablet by Edenbridge Pharmaceuticals, LLC
  • 42799-208 Tinidazole 500 mg Oral Tablet by Edenbridge Pharmaceuticals, LLC
  • 43386-550 Tinidazole 250 mg Oral Tablet by Gavis Pharmaceuticals, LLC
  • 43386-551 Tinidazole 500 mg Oral Tablet by Gavis Pharmaceuticals, LLC
  • 44523-425 Tinidazole 250 mg Oral Tablet by Biocomp Pharma, Inc.
  • 44523-450 Tinidazole 500 mg Oral Tablet by Biocomp Pharma, Inc.
  • 52682-043 Tinidazole 250 mg Oral Tablet by Ingenus Pharmaceuticals Nj, LLC
  • 52682-044 Tinidazole 500 mg Oral Tablet by Ingenus Pharmaceuticals Nj, LLC
  • 53002-1611 Tinidazole 500 mg Oral Tablet by Rpk Pharmaceuticals, Inc.
  • 63629-8386 Tinidazole 500 mg Oral Tablet by Bryant Ranch Prepack
  • 67296-1729 Tinidazole 500 mg Oral Tablet, Film Coated by Redpharm Drug, Inc.

NDC QR Code

Scan the QR code below to easily reference this data in the future:

NDC 0054-0348 QR Code

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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.