43063-612 : Topiramate 50 mg Oral Tablet, Film Coated


NDC: 43063-612
Labeler: Pd-rx Pharmaceuticals, Inc.
Product Type: Human Prescription Drug
Drug Name:  Topiramate
Dosage Form: Oral Tablet, Film Coated
Application #: ANDA077627
Rev. Date: 


Appearance:


Markings: G;50
Shapes:  Round
Colors:  Yellow
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.

G 50: (68462-153) Topiramate 50 mg 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:

  • 43063-612-30: 30 TABLET, FILM COATED IN 1 BOTTLE, PLASTIC (43063‑612‑30)
  • 43063-612-60: 60 TABLET, FILM COATED IN 1 BOTTLE, PLASTIC (43063‑612‑60)

Active Ingredients:

  • Topiramate

Dosage Strength:

  • 50 mg

Inactive Ingredients:

  • Lactose Monohydrate
  • Cellulose, Microcrystalline
  • Magnesium Stearate
  • Hypromelloses
  • Titanium Dioxide
  • Polyethylene Glycols
  • Polysorbate 80
  • Water
  • Ferric Oxide Yellow
  • Fd&c Yellow No. 6
  • Sodium Starch Glycolate Type a Potato
  • Starch, Corn

Pharmaceutical Classes:

  • Decreased Central Nervous System Disorganized Electrical Activity [PE]
  • Cytochrome P450 3A4 Inducers [MoA]
  • Cytochrome P450 2C19 Inhibitors [MoA]

Related Products:

Based on records with the same trade name.
  • 43063-094 Topiramate 25 mg Oral Tablet by Pd-rx Pharmaceuticals, Inc.
  • 43063-114 Topiramate 50 mg Oral Tablet by Pd-rx Pharmaceuticals, Inc.
  • 43063-189 Topiramate 100 mg Oral Tablet by Pd-rx Pharmaceuticals, Inc.
  • 43063-417 Topiramate 25 mg Oral Tablet by Pd-rx Pharmaceuticals, Inc.
  • 43063-436 Topiramate 100 mg Oral Tablet by Pd-rx Pharmaceuticals, Inc.
  • 43063-538 Topiramate 50 mg Oral Tablet by Pd-rx Pharmaceuticals, Inc.
  • 43063-573 Topiramate 25 mg Oral Tablet, Film Coated by Pd-rx Pharmaceuticals, Inc.
  • 43063-605 Topiramate 100 mg Oral Tablet, Film Coated by Pd-rx Pharmaceuticals, Inc.
  • 43063-729 Topiramate 100 mg Oral Tablet by Pd-rx Pharmaceuticals, Inc.
  • 43063-734 Topiramate 50 mg Oral Tablet by Pd-rx Pharmaceuticals, Inc.
  • 43063-735 Topiramate 25 mg Oral Tablet by Pd-rx Pharmaceuticals, Inc.
  • 43063-997 Topiramate 50 mg Oral Tablet, Film Coated by Pd-rx Pharmaceuticals, Inc.
  • 43063-998 Topiramate 25 mg Oral Tablet, Film Coated by Pd-rx Pharmaceuticals, Inc.
  • 72789-004 Topiramate 100 mg Oral Tablet, Film Coated by Pd-rx Pharmaceuticals, Inc.
  • 0093-0155 Topiramate 25 mg Oral Tablet by Teva Pharmaceuticals USA Inc
  • 0093-7219 Topiramate 100 mg Oral Tablet by Teva Pharmaceuticals USA Inc
  • 0093-7220 Topiramate 200 mg Oral Tablet by Teva Pharmaceuticals USA Inc
  • 0093-7335 Topiramate 15 mg Oral Capsule by Teva Pharmaceuticals USA Inc
  • 0093-7336 Topiramate 25 mg Oral Capsule by Teva Pharmaceuticals USA Inc
  • 0093-7540 Topiramate 50 mg Oral Tablet by Teva Pharmaceuticals USA Inc
  • More related products ...

NDC QR Code

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NDC 43063-612 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.