43063-522 : Atovaquone and Proguanil Hcl Oral Tablet, Film Coated


NDC: 43063-522
Labeler: Pd-rx Pharmaceuticals, Inc.
Product Type: Human Prescription Drug
Drug Name:  Atovaquone and Proguanil Hcl
Dosage Form: Oral Tablet, Film Coated
Application #: NDA021078
Rev. Date: 


Appearance:


Markings: GX;CM3
Shapes:  Round
Colors:  Pink
Size (mm): 11
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.

GX CM3: (66993-060) Atovaquone and Proguanil Hcl Oral Tablet, Film Coated 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:

  • 43063-522-07: 7 TABLET, FILM COATED IN 1 BOTTLE, PLASTIC (43063‑522‑07)
  • 43063-522-14: 14 TABLET, FILM COATED IN 1 BOTTLE, PLASTIC (43063‑522‑14)
  • 43063-522-20: 20 TABLET, FILM COATED IN 1 BOTTLE, PLASTIC (43063‑522‑20)
  • 43063-522-24: 24 TABLET, FILM COATED IN 1 BOTTLE, PLASTIC (43063‑522‑24)
  • 43063-522-68: 190 TABLET, FILM COATED IN 1 BOTTLE, PLASTIC (43063‑522‑68)
  • 43063-522-69: 280 TABLET, FILM COATED IN 1 BOTTLE, PLASTIC (43063‑522‑69)
  • 43063-522-73: 375 TABLET, FILM COATED IN 1 BOTTLE, PLASTIC (43063‑522‑73)

Active Ingredients:

  • Atovaquone
  • Proguanil Hydrochloride

Dosage Strength:

  • 250 mg
  • 100 mg

Inactive Ingredients:

  • Hydroxypropyl Cellulose, Low Substituted
  • Magnesium Stearate
  • Cellulose, Microcrystalline
  • Poloxamer 188
  • Povidone K30
  • Sodium Starch Glycolate Type a Potato
  • Hypromelloses
  • Polyethylene Glycol 400
  • Polyethylene Glycol 8000
  • Ferric Oxide Red
  • Titanium Dioxide

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 50090-2980 Atovaquone and Proguanil Hcl Oral Tablet, Film Coated by A-s Medication Solutions
  • 63629-5531 Atovaquone and Proguanil Hcl Oral Tablet, Film Coated by Bryant Ranch Prepack
  • 66993-060 Atovaquone 250 mg / Proguanil Hydrochloride 100 mg Oral Tablet by Prasco Laboratories

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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.