Bupivacaine Hydrochloride
- Product NDC
- 85766-013
- 11-digit product format
- 857660013
- Labeler code
- 85766
- Product ID
- 85766-013_49eeda32-7627-4c62-e063-6394a90af3eb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- BUPIVACAINE HYDROCHLORIDE
- Dosage form
- INJECTION, SOLUTION
- Route
- EPIDURAL; INTRACAUDAL; PERINEURAL
- Labeler
- Sportpharm LLC
- Application
- ANDA070584
- Marketing category
- ANDA
- Marketing start
- 2005-11-22
- Substance
- BUPIVACAINE HYDROCHLORIDE
- Active strength
- 5 mg/mL
- Pharmacologic classes
- Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Bupivacaine Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BUPIVACAINE HYDROCHLORIDE | 5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7TQO7W3VT8 |
| Rxcui | 1724880 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 85766-013-10 | Bupivacaine Hydrochloride | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 10 | | 4 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 85766-013-10 | 85766001310 | 10 mL in 1 VIAL, SINGLE-DOSE (85766-013-10) | 10 ml | 2025-06-20 | No | No | Current |