0378-5204 : Montelukast 4 mg (As Montelukast Sodium 4.2 mg) Chewable Tablet


NDC: 0378-5204
Labeler: Mylan Pharmaceuticals Inc.
Product Type: Human Prescription Drug
Drug Name:  Montelukast Sodium
Dosage Form: Oral Tablet, Chewable
Application #: ANDA079142
Rev. Date: 


Appearance:


Markings: ML;4
Shapes:  Round
Colors:  Pink
Size (mm): 7
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.

NDC Package Codes:

  • 0378-5204-05: 500 TABLET, CHEWABLE IN 1 BOTTLE, PLASTIC (0378‑5204‑05)
  • 0378-5204-77: 90 TABLET, CHEWABLE IN 1 BOTTLE, PLASTIC (0378‑5204‑77)
  • 0378-5204-93: 30 TABLET, CHEWABLE IN 1 BOTTLE, PLASTIC (0378‑5204‑93)

Active Ingredients:

  • Montelukast Sodium

Dosage Strength:

  • 4 mg

Inactive Ingredients:

  • Aspartame
  • Silicon Dioxide
  • Croscarmellose Sodium
  • Fd&c Red No. 40
  • Magnesium Stearate
  • Mannitol
  • Cellulose, Microcrystalline
  • Sodium Lauryl Sulfate

Pharmaceutical Classes:

  • Leukotriene Receptor Antagonist [EPC]
  • Leukotriene Receptor Antagonists [MoA]

Related Products:

Based on records with the same trade name.
  • 0378-5201 Montelukast 10 mg (As Montelukast Sodium 10.4 mg) Oral Tablet by Mylan Pharmaceuticals Inc.
  • 0378-5205 Montelukast 5 mg (As Montelukast Sodium 5.2 mg) Chewable Tablet by Mylan Pharmaceuticals Inc.
  • 0378-6040 Montelukast Sodium 4 mg/1 Oral Granule by Mylan Pharmaceuticals Inc.
  • 0054-0259 Montelukast 10 mg (As Montelukast Sodium 10.4 mg) Oral Tablet by Roxane Laboratories, Inc.
  • 0054-0288 Montelukast 4 mg (As Montelukast Sodium 4.2 mg) Chewable Tablet by Roxane Laboratories, Inc.
  • 0054-0289 Montelukast 5 mg (As Montelukast Sodium 5.2 mg) Chewable Tablet by Roxane Laboratories, Inc.
  • 0093-7424 Montelukast 4 mg (As Montelukast Sodium 4.2 mg) Chewable Tablet by Teva Pharmaceuticals USA Inc
  • 0093-7425 Montelukast 5 mg (As Montelukast Sodium 5.2 mg) Chewable Tablet by Teva Pharmaceuticals USA Inc
  • 0093-7426 Montelukast 10 mg (As Montelukast Sodium 10.4 mg) Oral Tablet by Teva Pharmaceuticals USA Inc
  • 0093-7487 Montelukast Sodium 4 mg Oral Granule by Teva Pharmaceuticals USA, Inc.
  • 0603-4653 Montelukast 4 mg (As Montelukast Sodium 4.2 mg) Chewable Tablet by Qualitest Pharmaceuticals
  • 0603-4654 Montelukast 5 mg (As Montelukast Sodium 5.2 mg) Chewable Tablet by Qualitest Pharmaceuticals
  • 0603-4655 Montelukast 10 mg (As Montelukast Sodium 10.4 mg) Oral Tablet by Qualitest Pharmaceuticals
  • 0615-7748 Montelukast Sodium 10 mg Oral Tablet, Film Coated by Ncs Healthcare of Ky, Inc Dba Vangard Labs
  • 0615-7983 Montelukast Sodium 10 mg Oral Tablet by Ncs Healthcare of Ky, Inc Dba Vangard Labs
  • 0904-6310 Montelukast Sodium 10 mg Oral Tablet by Major Pharmaceuticals
  • 0904-6529 Montelukast Sodium 10 mg Oral Tablet, Film Coated by Major Pharmaceuticals
  • 13668-079 Montelukast 4 mg (As Montelukast Sodium 4.2 mg) Chewable Tablet by Torrent Pharmaceuticals Limited
  • 13668-080 Montelukast 5 mg (As Montelukast Sodium 5.2 mg) Chewable Tablet by Torrent Pharmaceuticals Limited
  • 13668-081 Montelukast 10 mg (As Montelukast Sodium 10.4 mg) Oral Tablet by Torrent Pharmaceuticals Limited
  • More related products ...

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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.