Product NDC: | 52584-559 |
Proprietary Name: | Marcaine |
Non Proprietary Name: | Bupivacaine Hydrochloride |
Active Ingredient(s): | 2.5 mg/mL & nbsp; Bupivacaine Hydrochloride |
Administration Route(s): | EPIDURAL; INFILTRATION |
Dosage Form(s): | INJECTION, SOLUTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 52584-559 |
Labeler Name: | General Injectables & Vaccines, Inc |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA016964 |
Marketing Category: | NDA |
Start Marketing Date: | 20100801 |
Package NDC: | 52584-559-10 |
Package Description: | 1 VIAL, SINGLE-DOSE in 1 BAG (52584-559-10) > 10 mL in 1 VIAL, SINGLE-DOSE |
NDC Code | 52584-559-10 |
Proprietary Name | Marcaine |
Package Description | 1 VIAL, SINGLE-DOSE in 1 BAG (52584-559-10) > 10 mL in 1 VIAL, SINGLE-DOSE |
Product NDC | 52584-559 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Bupivacaine Hydrochloride |
Dosage Form Name | INJECTION, SOLUTION |
Route Name | EPIDURAL; INFILTRATION |
Start Marketing Date | 20100801 |
Marketing Category Name | NDA |
Labeler Name | General Injectables & Vaccines, Inc |
Substance Name | BUPIVACAINE HYDROCHLORIDE |
Strength Number | 2.5 |
Strength Unit | mg/mL |
Pharmaceutical Classes | Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] |