43063-380 : Montelukast 10 mg (As Montelukast Sodium 10.4 mg) Oral Tablet


NDC43063-380
Labeler: Pd-rx Pharmaceuticals, Inc.
Product Type: Human Prescription Drug
Drug Name:  Montelukast Sodium
Dosage Form: Oral Tablet
Application #: ANDA090655
Rev. Date: 


Appearance:


Markings: 54;157
Shapes:  Round
Colors:  Brown
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.

54 157: (0054-0259) Montelukast 10 mg (As Montelukast Sodium 10.4 mg) Oral Tablet by Pd-rx 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:

  • 43063-380-15: 15 TABLET IN 1 BOTTLE, PLASTIC (43063‑380‑15)
  • 43063-380-30: 30 TABLET IN 1 BOTTLE, PLASTIC (43063‑380‑30)

Active Ingredients:

  • Montelukast Sodium

Dosage Strength:

  • 10 mg

Inactive Ingredients:

  • Lactose
  • Ferric Oxide Red
  • Ferric Oxide Yellow
  • Polyethylene Glycol 3350
  • Magnesium Stearate
  • Cellulose, Microcrystalline
  • Polyvinyl Alcohol
  • Sodium Starch Glycolate Type a Potato
  • Talc
  • Titanium Dioxide

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 43063-381 Montelukast 4 mg (As Montelukast Sodium 4.2 mg) Chewable Tablet by Pd-rx Pharmaceuticals, Inc.
  • 43063-762 Montelukast Sodium 10 mg Oral Tablet, Film Coated by Pd-rx Pharmaceuticals, Inc.
  • 72789-306 Montelukast Sodium 10 mg Oral Tablet, Film Coated by Pd-rx 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.
  • 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
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NDC QR Code

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