68462-402 : Atovaquone and Proguanil Hydrochloride Pediatric Oral Tablet, Film Coated


NDC68462-402
Labeler: Glenmark Pharmaceuticals Inc., USA
Product Type: Human Prescription Drug
Drug Name:  Atovaquone and Proguanil Hydrochloride Pediatric
Dosage Form: Oral Tablet, Film Coated
Application #: ANDA091211
Rev. Date: 


Appearance:


Markings: 70;G
Shapes:  Round
Colors:  Pink
Size (mm): 6
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:

  • 68462-402-01: 100 TABLET, FILM COATED IN 1 BOTTLE (68462‑402‑01)
  • 68462-402-30: 30 TABLET, FILM COATED IN 1 BOTTLE (68462‑402‑30)

Active Ingredients:

  • Atovaquone
  • Proguanil Hydrochloride

Dosage Strength:

  • 62.5 mg
  • 25 mg

Inactive Ingredients:

  • Silicon Dioxide
  • Ferric Oxide Red
  • Hypromellose 2910 (15 Mpa.s)
  • Hydroxypropyl Cellulose, Low Substituted
  • Magnesium Stearate
  • Cellulose, Microcrystalline
  • Poloxamer 188
  • Polyethylene Glycol 400
  • Polyethylene Glycol 8000
  • Povidone K30
  • Sodium Starch Glycolate Type a Potato
  • Titanium Dioxide

Pharmaceutical Classes:

  • Antimalarial [EPC]
  • Antiprotozoal [EPC]
  • Dihydrofolate Reductase Inhibitors [MoA]

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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.