0378-4160 : Atovaquone and Proguanil Hydrochloride Oral Tablet, Film Coated


NDC: 0378-4160
Labeler: Mylan Pharmaceuticals Inc.
Product Type: Human Prescription Drug
Drug Name:  Atovaquone and Proguanil Hydrochloride
Dosage Form: Oral Tablet, Film Coated
Application #: ANDA202362
Rev. Date: 


Appearance:


Markings: A;P;1;M
Shapes:  Round
Colors:  Brown
Size (mm): 7
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:

  • 0378-4160-01: 100 TABLET, FILM COATED IN 1 BOTTLE, PLASTIC (0378‑4160‑01)
  • 0378-4160-05: 500 TABLET, FILM COATED IN 1 BOTTLE, PLASTIC (0378‑4160‑05)

Active Ingredients:

  • Atovaquone
  • Proguanil Hydrochloride

Dosage Strength:

  • 62.5 mg
  • 25 mg

Inactive Ingredients:

  • Ferrosoferric Oxide
  • Crospovidone
  • Hypromelloses
  • Lactose Monohydrate
  • Magnesium Stearate
  • Cellulose, Microcrystalline
  • Poloxamer 188
  • Polyethylene Glycols
  • Povidones
  • Ferric Oxide Red
  • Titanium Dioxide
  • Ferric Oxide Yellow

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 0378-4162 Atovaquone and Proguanil Hydrochloride Oral Tablet, Film Coated by Mylan Pharmaceuticals Inc.
  • 10544-909 Atovaquone and Proguanil Hydrochloride Oral Tablet, Film Coated by Blenheim Pharmacal, Inc.
  • 33261-900 Atovaquone 250 mg / Proguanil Hydrochloride 100 mg Oral Tablet by Aidarex Pharmaceuticals LLC
  • 42254-150 Atovaquone 250 mg / Proguanil Hydrochloride 100 mg Oral Tablet by Rebel Distributors Corp
  • 43063-393 Atovaquone 250 mg / Proguanil Hydrochloride 100 mg Oral Tablet by Pd-rx Pharmaceuticals, Inc.
  • 50090-1302 Atovaquone and Proguanil Hydrochloride Oral Tablet, Film Coated by A-s Medication Solutions
  • 51407-869 Atovaquone and Proguanil Hydrochloride Oral Tablet, Film Coated by Golden State Medical Supply, Inc.
  • 53034-404 Atovaquone 250 mg / Proguanil Hydrochloride 100 mg Oral Tablet by Clinical Solutions
  • 54868-6393 Atovaquone 250 mg / Proguanil Hydrochloride 100 mg Oral Tablet by Physicians Total Care, Inc.
  • 58118-0404 Atovaquone 250 mg / Proguanil Hydrochloride 100 mg Oral Tablet by Clinical Solutions Wholesale
  • 60760-498 Atovaquone and Proguanil Hydrochloride Oral Tablet, Film Coated by St. Mary's Medical Park Pharmacy
  • 63187-879 Atovaquone and Proguanil Hydrochloride Oral Tablet, Film Coated by Proficient Rx Lp
  • 68001-245 Atovaquone and Proguanil Hydrochloride Oral Tablet, Film Coated by Bluepoint Laboratories
  • 68071-3473 Atovaquone and Proguanil Hydrochloride Oral Tablet, Film Coated by Nucare Pharmaceuticals, Inc.
  • 68071-3488 Atovaquone and Proguanil Hydrochloride Oral Tablet, Film Coated by Nucare Pharmaceuticals, Inc.
  • 68258-1104 Atovaquone 250 mg / Proguanil Hydrochloride 100 mg Oral Tablet by Dispensing Solutions, Inc.
  • 68462-404 Atovaquone 250 mg / Proguanil Hydrochloride 100 mg Oral Tablet by Glenmark Generics Inc., USA
  • 68462-563 Atovaquone 62.5 mg / Proguanil Hydrochloride 25 mg Oral Tablet by Glenmark Generics Inc

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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.