0121-1012 : Lacosamide 50 mg/5ml Oral Solution


NDC: 0121-1012
Labeler: Pai Holdings, LLC
Product Type: Human Prescription Drug
Drug Name:  Lacosamide
Dosage Form: Oral Solution
Application #: ANDA216151
Rev. Date: 
CSA Schedule: CV (US) [1]


[1] Schedule V Controlled Substance: Low potential for abuse relative to substances listed in Schedule IV and consist primarily of preparations containing limited quantities of certain narcotics. (i.e. Cough preparations containing not more than 200 milligrams of Codeine per 100 milliliters or per 100 grams [such as Robitussin AC, Phenergan with Codeine], and Ezogabine). More Details: US Dept of Justice Controlled Substance Schedules.

NDC Package Codes:

  • 0121-1012-95: 1 TRAY IN 1 CASE (0121‑1012‑95) / 10 CUP, UNIT‑DOSE IN 1 TRAY / 5 ML IN 1 CUP, UNIT‑DOSE (0121‑1012‑05)

Active Ingredients:

  • Lacosamide

Dosage Strength:

  • 50 mg/5mL

Pharmaceutical Classes:

  • Decreased Central Nervous System Disorganized Electrical Activity [PE]

Related Products:

Based on records with the same trade name.
  • 0121-2024 Lacosamide 100 mg/10ml Oral Solution by Pai Holdings, LLC
  • 0121-3036 Lacosamide 150 mg/15ml Oral Solution by Pai Holdings, LLC
  • 0121-4048 Lacosamide 200 mg/20ml Oral Solution by Pai Holdings, LLC
  • 0121-4840 Lacosamide 200 mg/20ml Oral Solution by Pai Holdings, LLC
  • 0121-0992 Lacosamide 50 mg/5ml Oral Solution by Pai
  • 0121-1984 Lacosamide 100 mg/10ml Oral Solution by Pai
  • 0121-2976 Lacosamide 150 mg/15ml Oral Solution by Pai
  • 0121-3968 Lacosamide 200 mg/20ml Oral Solution by Pai
  • 0904-7244 Lacosamide 50 mg Oral Tablet, Film Coated by Major Pharmaceuticals
  • 0904-7245 Lacosamide 100 mg Oral Tablet, Film Coated by Major Pharmaceuticals
  • 0904-7246 Lacosamide 150 mg Oral Tablet, Film Coated by Major Pharmaceuticals
  • 0904-7247 Lacosamide 200 mg Oral Tablet, Film Coated by Major Pharmaceuticals
  • 0904-7463 Lacosamide 10 mg/ml Oral Solution by Major Pharmaceuticals
  • 0904-7464 Lacosamide 100 mg/10ml Oral Solution by Major Pharmaceuticals
  • 14335-330 Lacosamide 10 mg/ml Intravenous Injection by Hainan Poly Pharm. Co., Ltd.
  • 14445-129 Lacosamide 50 mg Oral Tablet by Indoco Remedies Limited
  • 14445-130 Lacosamide 100 mg Oral Tablet by Indoco Remedies Limited
  • 14445-131 Lacosamide 150 mg Oral Tablet by Indoco Remedies Limited
  • 14445-132 Lacosamide 200 mg Oral Tablet by Indoco Remedies Limited
  • 14445-406 Lacosamide 10 mg/ml Intravenous Injection by Indoco Remedies Limited
  • 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.