BUPIVACAINE HYDROCHLORIDE injection, solution
- Product NDC
- 51662-1638
- 11-digit product format
- 516621638
- Labeler code
- 51662
- Product ID
- 51662-1638_0f952dd8-92a8-2eb0-e063-6394a90a8c35
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- BUPIVACAINE HYDROCHLORIDE injection, solution
- Dosage form
- INJECTION, SOLUTION
- Route
- PERINEURAL
- Labeler
- HF Acquisition Co LLC, DBA HealthFirst
- Application
- ANDA207183
- Marketing category
- ANDA
- Marketing start
- 2016-05-13
- 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 HYDROCHLORIDE injection, solution
- 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 | 1012404 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51662-1638-2 | BUPIVACAINE HYDROCHLORIDE injection, solution | 50 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 50 | | 2 |
| 51662-1638-2 | BUPIVACAINE HYDROCHLORIDE injection, solution | 1 in 1 POUCH | INJECTION, SOLUTION | 1 | | 2 |
| 51662-1638-3 | BUPIVACAINE HYDROCHLORIDE injection, solution | 25 in 1 CASE | INJECTION, SOLUTION | 25 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51662-1638 | BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] | 2 | Current NDC, 3 package rows | 20240123_06c15208-c600-7173-e063-6394a90a2f94.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 |
|---|
| 51662-1638-2 | 51662163802 | 50 mL in 1 VIAL, MULTI-DOSE | 50 ml | | | | Historical |
| 51662-1638-3 | 51662163803 | 25 POUCH in 1 CASE (51662-1638-3) / 1 VIAL, MULTI-DOSE in 1 POUCH (51662-1638-2) / 50 mL in 1 VIAL, MULTI-DOSE | 25 pouch | 2023-10-02 | No | No | Current |