BUPIVACAINE HYDROCHLORIDE
- Product NDC
- 51662-1396
- 11-digit product format
- 516621396
- Labeler code
- 51662
- Product ID
- 51662-1396_1b5824c7-c46a-48c6-e063-6394a90a22ce
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- BUPIVACAINE HYDROCHLORIDE
- Dosage form
- INJECTION, SOLUTION
- Route
- PERINEURAL
- Labeler
- HF Acquisition Co LLC, DBA HealthFirst
- Application
- ANDA070597
- Marketing category
- ANDA
- Marketing start
- 2019-10-16
- 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
- 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 |
|---|
| 51662-1396-1 | BUPIVACAINE HYDROCHLORIDE | 50 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 50 | | 11 |
| 51662-1396-2 | BUPIVACAINE HYDROCHLORIDE | 1 mL in 1 POUCH | INJECTION, SOLUTION | 1 | | 11 |
| 51662-1396-3 | BUPIVACAINE HYDROCHLORIDE | 25 in 1 CASE | INJECTION, SOLUTION | 25 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51662-1396 | BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION 0.25% BUPIVACAINE HCL INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] | 11 | Current NDC, Legacy NDC, 3 package rows | 20240622_950d82b6-76a1-0c08-e053-2a95a90a3a92.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 |
|---|
| 51662-1396-1 | 51662139601 | 50 mL in 1 VIAL, MULTI-DOSE (51662-1396-1) | 50 ml | 2019-10-16 | 0000-00-00 | No | No | Current |
| 51662-1396-2 | 51662139602 | 1 mL in 1 POUCH | 1 ml | | | | | Historical |
| 51662-1396-3 | 51662139603 | 25 POUCH in 1 CASE (51662-1396-3) / 1 mL in 1 POUCH (51662-1396-2) | 25 pouch | 2020-10-27 | 0000-00-00 | No | No | Current |