65162-958 : Lamotrigine 100 mg Oral Tablet, Film Coated, Extended Release


NDC: 65162-958
Labeler: Amneal Pharmaceuticals LLC
Product Type: Human Prescription Drug
Drug Name:  Lamotrigine
Dosage Form: Oral Tablet, Film Coated, Extended Release
Application #: ANDA207497
Rev. Date: 


Appearance:


Markings: A;958
Shapes:  Round
Colors:  Orange
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.

NDC Package Codes:

  • 65162-958-03: 30 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE (65162‑958‑03)
  • 65162-958-09: 90 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE (65162‑958‑09)

Active Ingredients:

  • Lamotrigine

Dosage Strength:

  • 100 mg

Inactive Ingredients:

  • Silicon Dioxide
  • Hypromelloses
  • Lactose Monohydrate
  • Polyethylene Glycol, Unspecified
  • Magnesium Stearate
  • Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type a
  • Polyvinyl Alcohol, Unspecified
  • Talc
  • Titanium Dioxide
  • Triethyl Citrate
  • Ferric Oxide Red
  • Ferric Oxide Yellow /

Pharmaceutical Classes:

  • Anti-epileptic Agent [EPC]
  • Decreased Central Nervous System Disorganized Electrical Activity [PE]
  • Dihydrofolate Reductase Inhibitors [MoA]
  • Mood Stabilizer [EPC]
  • Organic Cation Transporter 2 Inhibitors [MoA]

Related Products:

Based on records with the same trade name.
  • 65162-949 Lamotrigine 25 mg Oral Tablet, Film Coated, Extended Release by Amneal Pharmaceuticals LLC
  • 65162-956 Lamotrigine 50 mg Oral Tablet, Film Coated, Extended Release by Amneal Pharmaceuticals LLC
  • 65162-986 Lamotrigine 200 mg Oral Tablet, Film Coated, Extended Release by Amneal Pharmaceuticals LLC
  • 65162-988 Lamotrigine 250 mg Oral Tablet, Film Coated, Extended Release by Amneal Pharmaceuticals LLC
  • 65162-990 Lamotrigine 300 mg Oral Tablet, Film Coated, Extended Release by Amneal Pharmaceuticals LLC
  • 0093-0039 Lamotrigine 25 mg Oral Tablet by Teva Pharmaceuticals USA Inc
  • 0093-0132 Lamotrigine 25 mg Chewable Tablet by Teva Pharmaceuticals USA Inc
  • 0093-0463 Lamotrigine 100 mg Oral Tablet by Teva Pharmaceuticals USA Inc
  • 0093-0688 Lamotrigine 5 mg Chewable Tablet by Teva Pharmaceuticals USA Inc
  • 0093-7247 Lamotrigine 150 mg Oral Tablet by Teva Pharmaceuticals USA Inc
  • 0093-7248 Lamotrigine 200 mg Oral Tablet by Teva Pharmaceuticals USA Inc
  • 0115-1526 Lamotrigine 25 mg Oral Tablet, Orally Disintegrating by Global Pharmaceuticals, Division of Impax Laboratories Inc.
  • 0115-1527 Lamotrigine 50 mg Oral Tablet, Orally Disintegrating by Global Pharmaceuticals, Division of Impax Laboratories Inc.
  • 0115-1528 Lamotrigine 100 mg Oral Tablet, Orally Disintegrating by Global Pharmaceuticals, Division of Impax Laboratories Inc.
  • 0115-1529 Lamotrigine 200 mg Oral Tablet, Orally Disintegrating by Global Pharmaceuticals, Division of Impax Laboratories Inc.
  • 0115-9939 Lamotrigine 25 mg Oral Tablet, Orally Disintegrating by Impax Generics
  • 0115-9940 Lamotrigine 50 mg Oral Tablet, Orally Disintegrating by Impax Generics
  • 0115-9941 Lamotrigine 100 mg Oral Tablet, Orally Disintegrating by Impax Generics
  • 0115-9942 Lamotrigine 200 mg Oral Tablet, Orally Disintegrating by Impax Generics
  • 0143-9964 Lamotrigine 200 mg Oral Tablet by West-ward Pharmaceutical Corp
  • More related products ...

NDC QR Code

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NDC 65162-958 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.