53808-0995 : Montelukast Sodium 10 mg Oral Tablet, Film Coated


NDC53808-0995
Labeler: State of Florida Doh Central Pharmacy
Product Type: Human Prescription Drug
Drug Name:  Montelukast Sodium
Dosage Form: Oral Tablet, Film Coated
Application #: ANDA091576
Rev. Date: 


Appearance:


Markings: E225
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.

E225: (0603-4655) Montelukast Sodium 10 mg Oral Tablet, Film Coated by State of Florida Doh Central Pharmacy
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:

  • 53808-0995-1: 30 TABLET, FILM COATED IN 1 BLISTER PACK (53808‑0995‑1)

Active Ingredients:

  • Montelukast Sodium

Dosage Strength:

  • 10 mg

Inactive Ingredients:

  • Croscarmellose Sodium
  • Hydroxypropyl Cellulose (Type H)
  • Lactose Monohydrate
  • Magnesium Stearate
  • Cellulose, Microcrystalline
  • Hypromellose 2208 (100 Mpa.s)
  • Ferric Oxide Red
  • Titanium Dioxide
  • Ferric Oxide Yellow

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 53808-0690 Montelukast Sodium 10 mg Oral Tablet, Film Coated by State of Florida Doh Central Pharmacy
  • 53808-0920 Montelukast Sodium 10 mg Oral Tablet, Film Coated by State of Florida Doh Central Pharmacy
  • 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
  • More related products ...

NDC QR Code

Scan the QR code below to easily reference this data in the future:

NDC 53808-0995 QR Code

< Prev: 53808-0994Next: 53808-0997 >

Related Discussions:

MONTELUKAST SODIUM
MY DOCTOR TOLD ME TO TAKE MONTELUKAST TABLET FOR 3MONTHS TO CURE MY ASTHMA AND SEVERE ALLERGYCRINITIS,MAY I KNOW THE SID... 6 replies
montelukast sodium levocetirizine hydrochloride syrup
Baby 7 months old & 8 kgs was suffering from cold (for the past one month) doctor suggested Crize M syrup montelukas... 2 replies
MONTAIR LC with montelukast sodium levocetirizine hydrochloride salts tablet
is this medicine a steroid or not? If yes then what are its immediate side effects and long term side effects? ## Based ... 2 replies
About Tablet Name Rinostat Lm Which Contains Levocetirizine Hydrochloride I P 5mg Montelukast Sodium 10mg
doctor advice me to take tablet Actifed but it's not avialble so I want to know wheather I can the tablet Rinostat-L...
Montelukast And Levocetirizine Dihydrochloride Tablets
I need details about this combination product, what its uses are and side effects? Also, what is the brand name of this ... 14 replies
montelukast montemax
cough ## Montelukast is used to treat asthma and allergies. The side effects may include: nausea, drowsiness, dizziness ... 7 replies
Montelukast And Levocetirizine
I hv been taking telekast-l for the past 2 yrs i tab at bed time.My question to u is could this medicine be harmful for ... 6 replies
montelukast side effects
I have been taking montelukast, generic for Singular, 1 tablet daily, for slightly less than a month. I also use Advair ... 5 replies
Montelukast + olopatadine combination
generic name of above combination. nd manufacturing company of API as well as formulation ## That would be the generic n... 4 replies
montelukast and levocetirizine dihydrochloride tablets Mankind make
I m prescribed this medicine for allergic cold & sneezing problem. Needs a solution without medicine as was not havi... 3 replies




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.