Bupivacaine HCl
- Product NDC
- 70594-119
- 11-digit product format
- 705940119
- Labeler code
- 70594
- Product ID
- 70594-119_6776a37a-5872-4c0c-b039-6d93e3604e7c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bupivacaine Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- PERINEURAL
- Labeler
- Xellia Pharmaceuticals USA LLC
- Application
- ANDA091503
- Marketing category
- ANDA
- Marketing start
- 2023-08-01
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Bupivacaine HCl
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BUPIVACAINE HYDROCHLORIDE | 5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7TQO7W3VT8 |
| Rxcui | 1012396, 1012404 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70594-119-01 | Bupivacaine HCl | 50 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 50 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70594-119 | BUPIVACAINE HCL (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [XELLIA PHARMACEUTICALS USA LLC] | 3 | Current NDC, 1 package rows | 20230801_3335dabe-66d5-440b-a59a-b62993030e0f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70594-119-01 | 70594011901 | 50 mL in 1 VIAL, MULTI-DOSE (70594-119-01) | 50 ml | 2023-08-01 | No | No | Historical |