| Product Information |
|
| Registration Number |
DRP-15007
|
| Generic Name |
Bupivacaine hydrochloride
|
| Brand Name |
Spentocaine Heavy
|
| Dosage Strength |
5 mg/mL (0.5% w/v)
|
| Dosage Form |
Solution for Intrathecal Injection
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
Local Anesthetic (Amide)
|
| Packaging |
5 mL - capacity USP Type I clear glass ampoule x 4 mL net content; 2 plastic trays each containing 10 ampoules (Box of 20 ampoules)
|
| Manufacturer |
Steril-Gene Life Sciences (P) Limited
|
| Country of Origin |
India
|
| Trader |
|
| Importer |
Macropharma Corporation
|
| Distributor |
Macropharma Corporation
|
| Application Type |
Initial
|
| Issuance Date |
08 March 2024
|
| Expiry Date |
08 March 2029
|