50268-575 : Montelukast Sodium 10 mg Oral Tablet, Film Coated
NDC: | 50268-575 |
Labeler: | Avpak |
Product Type: | Human Prescription Drug |
Drug Name: | Montelukast Sodium |
Dosage Form: | Oral Tablet, Film Coated |
Application #: | ANDA201522 |
Rev. Date: |
Appearance:
Markings: | KU;210 |
Shapes: |
Round |
Colors: |
White |
Size (mm): | 8 |
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. |
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:
- 50268-575-15: 50 BLISTER PACK IN 1 BOX, UNIT‑DOSE (50268‑575‑15) > 1 TABLET, FILM COATED IN 1 BLISTER PACK (50268‑575‑11)
Active Ingredients:
- Montelukast Sodium
Dosage Strength:
- 10 mg
Inactive Ingredients:
- Silicon Dioxide
- Croscarmellose Sodium
- Hydroxypropyl Cellulose (Type H)
- Mannitol
- Cellulose, Microcrystalline
- Polyethylene Glycols
- Polyvinyl Alcohol
- Sodium Stearyl Fumarate
- Talc
- Titanium Dioxide
Pharmaceutical Classes:
- Leukotriene Receptor Antagonist [EPC]
- Leukotriene Receptor Antagonists [MoA]
Related Products:
Based on records with the same trade name.- 50268-573 Montelukast Sodium 4 mg Oral Tablet, Chewable by Avpak
- 50268-574 Montelukast Sodium 5 mg Oral Tablet, Chewable by Avpak
- 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.
- 0378-5201 Montelukast 10 mg (As Montelukast Sodium 10.4 mg) Oral Tablet by Mylan Pharmaceuticals Inc.
- 0378-5204 Montelukast 4 mg (As Montelukast Sodium 4.2 mg) Chewable 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.
- 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
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