51128-501 : Montelukast 10 mg Oral Tablet, Film Coated


NDC51128-501
Labeler: Kemwell Biopharma Private Limited
Product Type: Human Prescription Drug
Drug Name:  Montelukast
Dosage Form: Oral Tablet, Film Coated
Application #: ANDA202859
Rev. Date: 


Appearance:


Markings: AUM101
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.

NDC Package Codes:

  • 51128-501-01: 30 TABLET, FILM COATED IN 1 BOTTLE (51128‑501‑01)
  • 51128-501-02: 90 TABLET, FILM COATED IN 1 BOTTLE (51128‑501‑02)
  • 51128-501-03: 1000 TABLET, FILM COATED IN 1 BOTTLE (51128‑501‑03)

Active Ingredients:

  • Montelukast Sodium

Dosage Strength:

  • 10 mg

Inactive Ingredients:

  • Cellulose, Microcrystalline
  • Lactose Monohydrate
  • Croscarmellose Sodium
  • Hydroxypropyl Cellulose (Type H)
  • Magnesium Stearate
  • Hypromelloses
  • Titanium Dioxide
  • Ferric Oxide Red
  • Ferric Oxide Yellow
  • Carnauba Wax

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 51128-502 Montelukast 4 mg Oral Tablet, Chewable by Kemwell Biopharma Private Limited
  • 51128-503 Montelukast 5 mg Oral Tablet, Chewable by Kemwell Biopharma Private Limited
  • 0143-9649 Montelukast 10 mg Oral Tablet, Film Coated by West Ward Pharmaceutical Corp
  • 0143-9650 Montelukast 5 mg Oral Tablet, Chewable by West Ward Pharmaceutical Corp
  • 0143-9651 Montelukast 4 mg Oral Tablet, Chewable by West Ward Pharmaceutical Corp
  • 0781-5554 Montelukast 4 mg (As Montelukast Sodium 4.2 mg) Chewable Tablet by Sandoz Inc
  • 0781-5555 Montelukast 5 mg (As Montelukast Sodium 5.2 mg) Chewable Tablet by Sandoz Inc
  • 0781-5560 Montelukast 10 mg (As Montelukast Sodium 10.4 mg) Oral Tablet by Sandoz Inc
  • 0904-6808 Montelukast 10 mg Oral Tablet, Film Coated by Major Pharmaceuticals
  • 31722-726 Montelukast 10 mg Oral Tablet, Film Coated by Camber Pharmaceuticals, Inc.
  • 33342-102 Montelukast 10 mg Oral Tablet by Macleods Pharmaceuticals Limited
  • 50090-6108 Montelukast 10 mg Oral Tablet, Film Coated by A-s Medication Solutions
  • 50090-6109 Montelukast 10 mg Oral Tablet, Film Coated by A-s Medication Solutions
  • 50268-556 Montelukast 10 mg Oral Tablet, Film Coated by Avpak
  • 53002-6441 Montelukast 10 mg Oral Tablet, Film Coated by Rpk Pharmaceuticals, Inc.
  • 54458-890 Montelukast 10 mg by International Labs, Inc.
  • 55154-8075 Montelukast 10 mg Oral Tablet, Film Coated by Cardinal Health
  • 58118-5560 Montelukast 10 mg (As Montelukast Sodium 10.4 mg) Oral Tablet by Clinical Solutions Wholesale
  • 63187-626 Montelukast 5 mg Oral Tablet, Chewable by Proficient Rx Lp
  • 63629-4886 Montelukast 10 mg (As Montelukast Sodium 10.4 mg) Oral Tablet by Bryant Ranch Prepack
  • More related products ...

NDC QR Code

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NDC 51128-501 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.