metoclopramide
metoclopramide is listed in the FDA National Drug Code directory with 6 NDC codes, marketed under brand name including Metoclopramide. Available dosage form: injection, solution.
Drug Details
- Generic Name
- metoclopramide
- Brand Names
- Metoclopramide
- Application Number
- ANDA073118
- Sponsor
- Hospira, Inc.
- NDC Codes
- 6
- Dosage Forms
- INJECTION, SOLUTION
- Routes
- INTRAMUSCULAR, INTRAVENOUS
- Active Ingredients
- METOCLOPRAMIDE HYDROCHLORIDE
Indications and Usage
1 INDICATIONS AND USAGE Metoclopramide tablets are indicated for the: Treatment for 4 to 12 weeks of symptomatic, documented gastroesophageal reflux in adults who fail to respond to conventional therapy. Relief of symptoms in adults with acute and recurrent diabetic gastroparesis. Limitations of Use : Metoclopramide tablets have not been shown to be safe and effective for the treatment of symptomatic, documented gastroesophageal reflux for longer than 12 weeks [see Warnings and Precautions ( 5.1 )]. Metoclopramide tablets are not recommended for use in pediatric patients due to the risk of developing tardive dyskinesia (TD) and other extrapyramidal symptoms as well as the risk of methemoglobinemia in neonates [see Use in Specific Populations ( 8.4 )] . Metoclopramide tablets are indicated for the: Treatment for 4 to 12 weeks of symptomatic, documented gastroesophageal reflux in adults who fail to respond to conventional therapy. ( 1 ) Relief of symptoms in adults with acute and recurrent diabetic gastroparesis. ( 1 ) Limitations of Use : Metoclopramide tablets have not been shown to be safe and effective for the treatment of gastroesophageal reflux for longer than 12 weeks. ( 1 , 5.1 ) Metoclopramide tablets are not recommended for use in pediatric patients due to the risk of tardive dyskinesia (TD) and other extrapyramidal symptoms as well as the risk of methemoglobinemia in neonates. ( 1 , 8.4 )