53217-315 : Topiramate 50 mg Oral Tablet


NDC: 53217-315
Labeler: Aidarex Pharmaceuticals LLC
Product Type: Human Prescription Drug
Drug Name:  Topiramate
Dosage Form: Oral Tablet
Application #: ANDA076343
Rev. Date: 


Appearance:


Markings: 123;C
Shapes:  Round
Colors:  Orange
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:

  • 53217-315-02: 120 TABLET IN 1 BOTTLE (53217‑315‑02)
  • 53217-315-07: 7 TABLET IN 1 BOTTLE (53217‑315‑07)
  • 53217-315-14: 14 TABLET IN 1 BOTTLE (53217‑315‑14)
  • 53217-315-28: 28 TABLET IN 1 BOTTLE (53217‑315‑28)
  • 53217-315-30: 30 TABLET IN 1 BOTTLE (53217‑315‑30)
  • 53217-315-60: 60 TABLET IN 1 BOTTLE (53217‑315‑60)
  • 53217-315-90: 90 TABLET IN 1 BOTTLE (53217‑315‑90)

Active Ingredients:

  • Topiramate

Dosage Strength:

  • 50 mg

Inactive Ingredients:

  • Lactose Monohydrate
  • Starch, Pregelatinized Corn
  • Cellulose, Microcrystalline
  • Sodium Starch Glycolate Type a Potato
  • Magnesium Stearate
  • Hypromellose 2910 (3 Mpa.s)
  • Hypromellose 2910 (6 Mpa.s)
  • Titanium Dioxide
  • Polyethylene Glycol 400
  • Polysorbate 80
  • Ferric Oxide Yellow
  • Ferric Oxide Red

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.
  • 53217-274 Topiramate 100 mg Oral Tablet by Aidarex Pharmaceuticals LLC
  • 53217-291 Topiramate 25 mg Oral Tablet by Aidarex Pharmaceuticals LLC
  • 53217-329 Topiramate 100 mg Oral Tablet by Aidarex Pharmaceuticals LLC
  • 33261-106 Topiramate 25 mg/1 Oral Tablet, Film Coated by Aidarex Pharmaceuticals LLC
  • 33261-400 Topiramate 50 mg/1 Oral Tablet by Aidarex Pharmaceuticals LLC
  • 33261-480 Topiramate 100 mg/1 Oral Tablet by Aidarex Pharmaceuticals LLC
  • 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
  • 0143-9755 Topiramate 200 mg/1 Oral Tablet, Film Coated by West-ward Pharmaceutical Corp
  • 0143-9756 Topiramate 100 mg/1 Oral Tablet, Film Coated by West-ward Pharmaceutical Corp
  • 0143-9757 Topiramate 50 mg/1 Oral Tablet, Film Coated by West-ward Pharmaceutical Corp
  • 0143-9758 Topiramate 25 mg/1 Oral Tablet, Film Coated by West-ward Pharmaceutical Corp
  • 0245-0707 Topiramate 25 mg Oral Tablet by Upsher-smith Laboratories, Inc.
  • 0245-0708 Topiramate 50 mg Oral Tablet by Upsher-smith Laboratories, Inc.
  • 0245-0709 Topiramate 100 mg Oral Tablet by Upsher-smith Laboratories, Inc.
  • 0245-0710 Topiramate 200 mg Oral Tablet by Upsher-smith Laboratories, Inc.
  • More related products ...

NDC 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.