BUPIVICAINE HYDROCHLORIDE
- Product NDC
- 51662-1456
- 11-digit product format
- 516621456
- Labeler code
- 51662
- Product ID
- 51662-1456_b107e2b0-091e-b326-e053-2a95a90aa253
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- BUPIVICAINE HYDROCHLORIDE
- Dosage form
- INJECTION, SOLUTION
- Route
- EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL
- Labeler
- HF Acquisition Co LLC, DBA HealthFirst
- Application
- ANDA070583
- Marketing category
- ANDA
- Marketing start
- 2019-12-12
- Substance
- BUPIVACAINE HYDROCHLORIDE
- Active strength
- 2.5 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
- BUPIVICAINE HYDROCHLORIDE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BUPIVACAINE HYDROCHLORIDE | 2.5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7TQO7W3VT8 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51662-1456-1 | BUPIVICAINE HYDROCHLORIDE | 30 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51662-1456 | BUPIVICAINE HYDROCHLORIDE INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] | 3 | Current NDC, Legacy NDC, 1 package rows | 20201007_99857946-6084-1bbd-e053-2a95a90af58c.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 51662-1456-1 | 51662145601 | 30 mL in 1 VIAL, SINGLE-DOSE (51662-1456-1) | 30 ml | 2019-12-12 | 0000-00-00 | No | No | Current |