BUPIVACAINE HCl
- Product NDC
- 51662-1588
- 11-digit product format
- 516621588
- Labeler code
- 51662
- Product ID
- 51662-1588_0ff9d690-ca06-4e75-e063-6394a90afd2a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- BUPIVACAINE HCl
- Dosage form
- INJECTION, SOLUTION
- Route
- PERINEURAL
- Labeler
- HF Acquisition Co LLC, DBA HealthFirst
- Application
- NDA018304
- Marketing category
- NDA
- Marketing start
- 2022-07-11
- 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 |
|---|
| 51662-1588-2 | BUPIVACAINE HCl | 50 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 50 | | 4 |
| 51662-1588-2 | BUPIVACAINE HCl | 1 in 1 POUCH | INJECTION, SOLUTION | 1 | | 4 |
| 51662-1588-3 | BUPIVACAINE HCl | 25 in 1 CASE | INJECTION, SOLUTION | 25 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51662-1588 | BUPIVACAINE HCL INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] | 4 | Current NDC, Legacy NDC, 3 package rows | 20240129_e391f807-7699-6d82-e053-2a95a90ab641.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 51662-1588-2 | 51662158802 | 50 mL in 1 VIAL, MULTI-DOSE | 50 ml | | | | | Historical |
| 51662-1588-3 | 51662158803 | 25 POUCH in 1 CASE (51662-1588-3) / 1 VIAL, MULTI-DOSE in 1 POUCH (51662-1588-2) / 50 mL in 1 VIAL, MULTI-DOSE | 25 pouch | 2022-07-11 | 0000-00-00 | No | No | Current |