Product NDC: | 63323-286 |
Proprietary Name: | NAROPIN |
Non Proprietary Name: | ROPIVACAINE HYDROCHLORIDE MONOHYDRATE |
Active Ingredient(s): | 5 mg/mL & nbsp; ROPIVACAINE HYDROCHLORIDE MONOHYDRATE |
Administration Route(s): | EPIDURAL; INFILTRATION; PERINEURAL |
Dosage Form(s): | INJECTION, SOLUTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 63323-286 |
Labeler Name: | APP Pharmaceuticals, LLC |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA020533 |
Marketing Category: | NDA |
Start Marketing Date: | 20090804 |
Package NDC: | 63323-286-23 |
Package Description: | 25 VIAL, SINGLE-DOSE in 1 CARTON (63323-286-23) > 20 mL in 1 VIAL, SINGLE-DOSE |
NDC Code | 63323-286-23 |
Proprietary Name | NAROPIN |
Package Description | 25 VIAL, SINGLE-DOSE in 1 CARTON (63323-286-23) > 20 mL in 1 VIAL, SINGLE-DOSE |
Product NDC | 63323-286 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | ROPIVACAINE HYDROCHLORIDE MONOHYDRATE |
Dosage Form Name | INJECTION, SOLUTION |
Route Name | EPIDURAL; INFILTRATION; PERINEURAL |
Start Marketing Date | 20090804 |
Marketing Category Name | NDA |
Labeler Name | APP Pharmaceuticals, LLC |
Substance Name | ROPIVACAINE HYDROCHLORIDE MONOHYDRATE |
Strength Number | 5 |
Strength Unit | mg/mL |
Pharmaceutical Classes | Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] |