BUPIVACAINE HCI AND EPINEPHRINE
- Product NDC
- 51662-1399
- 11-digit product format
- 516621399
- Labeler code
- 51662
- Product ID
- 51662-1399_10328ddf-6e3b-c9e0-e063-6294a90a52ed
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- BUPIVACAINE HCI AND EPINEPHRINE
- Dosage form
- INJECTION, SOLUTION
- Route
- PERINEURAL
- Labeler
- HF Acquisition Co LLC, DBA HealthFirst
- Application
- ANDA070968
- Marketing category
- ANDA
- Marketing start
- 2019-12-09
- Substance
- BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
- Active strength
- 5; .005 mg/mL; mg/mL
- Pharmacologic classes
- Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- BUPIVACAINE HCI AND EPINEPHRINE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BUPIVACAINE HYDROCHLORIDE | 5 mg/mL |
| EPINEPHRINE BITARTRATE | .005 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7TQO7W3VT8, 30Q7KI53AK |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51662-1399-1 | BUPIVACAINE HCI AND EPINEPHRINE | 50 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 50 | | 4 |
| 51662-1399-2 | BUPIVACAINE HCI AND EPINEPHRINE | 50 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 50 | | 4 |
| 51662-1399-2 | BUPIVACAINE HCI AND EPINEPHRINE | 1 in 1 POUCH | INJECTION, SOLUTION | 1 | | 4 |
| 51662-1399-3 | BUPIVACAINE HCI AND EPINEPHRINE | 25 in 1 CASE | INJECTION, SOLUTION | 25 | | 4 |
| 51662-1399-3 | BUPIVACAINE HCI AND EPINEPHRINE | 1 in 1 POUCH | INJECTION, SOLUTION | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51662-1399 | BUPIVACAINE HCI AND EPINEPHRINE INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] | 4 | Current NDC, Legacy NDC, 5 package rows | 20240131_99516811-56e2-9c8a-e053-2a95a90ac9cb.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 51662-1399-1 | 51662139901 | 50 mL in 1 VIAL, MULTI-DOSE (51662-1399-1) | 50 ml | 2019-12-09 | 0000-00-00 | No | No | Current |
| 51662-1399-2 | 51662139902 | 1 VIAL, MULTI-DOSE in 1 POUCH (51662-1399-2) / 50 mL in 1 VIAL, MULTI-DOSE | | 2021-01-26 | 0000-00-00 | No | No | Current |
| 51662-1399-3 | 51662139903 | 25 POUCH in 1 CASE (51662-1399-3) / 1 VIAL, MULTI-DOSE in 1 POUCH / 50 mL in 1 VIAL, MULTI-DOSE | 25 pouch | 2021-01-26 | 0000-00-00 | No | No | Current |