0378-0313 : Tolmetin 600 mg Oral Tablet


NDC0378-0313
Labeler: Mylan Pharmaceuticals Inc.
Product Type: Human Prescription Drug
Drug Name:  Tolmetin Sodium
Dosage Form: Oral Tablet, Film Coated
Application #: ANDA074473
Rev. Date: 


Appearance:


Markings: M;313
Shapes:  Oval
Colors:  White
Size (mm): 19
Segments: * 1

* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

M 313: (0378-0313) Tolmetin 600 mg Oral Tablet by Mylan Pharmaceuticals 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:

  • 0378-0313-01: 100 TABLET, FILM COATED IN 1 BOTTLE, PLASTIC (0378‑0313‑01)

Active Ingredients:

  • Tolmetin Sodium

Dosage Strength:

  • 600 mg

Inactive Ingredients:

  • Ferrosoferric Oxide
  • Crospovidone
  • Hypromelloses
  • Magnesium Stearate
  • Cellulose, Microcrystalline
  • Polydextrose
  • Polyethylene Glycols
  • Povidones
  • Starch, Corn
  • Sodium Lauryl Sulfate
  • Titanium Dioxide
  • Triacetin
  • Ferric Oxide Yellow

Pharmaceutical Classes:

  • Cyclooxygenase Inhibitors [MoA]
  • Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient]
  • Nonsteroidal Anti-inflammatory Drug [EPC]

Related Products:

Based on records with the same trade name.
  • 0378-5200 Tolmetin 400 mg (As Tolmetin Sodium Dihydrate 492 mg) Oral Capsule by Mylan Pharmaceuticals Inc.
  • 0093-2075 Tolmetin 400 mg (As Tolmetin Sodium Dihydrate 492 mg) Oral Capsule by Teva Pharmaceuticals USA Inc
  • 0093-8815 Tolmetin 400 mg (As Tolmetin Sodium Dihydrate 492 mg) Oral Capsule by Teva Pharmaceuticals USA Inc
  • 16571-825 Tolmetin Sodium 600 mg Oral Tablet, Film Coated by Rising Pharma Holdings, Inc.
  • 16571-826 Tolmetin Sodium 400 mg Oral Capsule by Rising Pharma Holdings, Inc.
  • 16590-987 Tolmetin 600 mg Oral Tablet by Stat Rx USA LLC
  • 53489-506 Tolmetin 200 mg Oral Tablet by Mutual Pharmaceutical Company, Inc.
  • 53489-507 Tolmetin 400 mg (As Tolmetin Sodium Dihydrate 492 mg) Oral Capsule by Mutual Pharmaceutical Company, Inc.

NDC QR Code

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NDC 0378-0313 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.