Product Information |
|
Registration Number |
DRP-15033
|
Generic Name |
Bupivacaine hydrochloride
|
Brand Name |
Recaine
|
Dosage Strength |
5 mg/mL (0.5% w/v)
|
Dosage Form |
Solution for Intrathecal Injection
|
Classification |
Prescription (Rx) Drug
|
Pharmacologic Category |
Local Anesthetic (Amide).
|
Packaging |
5 mL capacity USP Type I clear glass ampoule with yellow one-point-cut x 4 mL net content; 5 clear PVC tray each containing 10 ampoules (Box of 50 ampoules)
|
Manufacturer |
Reyon Pharmaceuticals Co., Ltd.
|
Country of Origin |
Korea
|
Trader |
|
Importer |
Jazmark Pharmaceutical
|
Distributor |
Jazmark Pharmaceutical
|
Application Type |
Initial
|
Issuance Date |
20 March 2024
|
Expiry Date |
20 March 2029
|