metoclopramide hydrochloride
metoclopramide hydrochloride is listed in the FDA National Drug Code directory with 8 NDC codes, marketed under brand names including METOCLOPRAMIDE, Metoclopramide, metoclopramide hydrochloride. Available dosage forms: injection, solution, injection, solution.
Drug Details
- Generic Name
- metoclopramide hydrochloride
- Brand Names
- METOCLOPRAMIDE, Metoclopramide, metoclopramide hydrochloride
- Application Number
- ANDA204756
- Sponsor
- Henry Schein, Inc.
- NDC Codes
- 8
- Dosage Forms
- INJECTION, SOLUTION, INJECTION, SOLUTION
- Routes
- INTRAMUSCULAR, INTRAVENOUS, ORAL
- Active Ingredients
- METOCLOPRAMIDE HYDROCHLORIDE
Indications and Usage
1 INDICATIONS AND USAGE Metoclopramide is 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. Metoclopramide is 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 is 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 ) Limitations of Use : Metoclopramide is 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) ].