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


NDC: 43063-380
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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NDC 43063-380 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.