Bupivacaine Hydrochloride and Epinephrine
- Product NDC
- 0404-9828
- 11-digit product format
- 004049828
- Labeler code
- 0404
- Product ID
- 0404-9828_d06af667-46dd-4cf0-84fa-87e9be2d6d77
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bupivacaine Hydrochloride and Epinephrine
- Dosage form
- INJECTION, SOLUTION
- Route
- EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL
- Labeler
- Henry Schein, Inc.
- Application
- ANDA071165
- Marketing category
- ANDA
- Marketing start
- 2022-01-09
- Substance
- BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
- Active strength
- 2.5; 5 mg/mL; ug/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 Hydrochloride and Epinephrine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BUPIVACAINE HYDROCHLORIDE | 2.5 mg/mL |
| EPINEPHRINE BITARTRATE | 5 ug/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7TQO7W3VT8, 30Q7KI53AK |
| Rxcui | 1012377 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0404-9828-30 | Bupivacaine Hydrochloride and Epinephrine | 30 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 30 | | 5 |
| 0404-9828-30 | Bupivacaine Hydrochloride and Epinephrine | 1 in 1 BAG | INJECTION, SOLUTION | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0404-9828 | BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION [HENRY SCHEIN, INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20241016_a1a96ebb-31f2-43d5-8dd9-b0cc0d9cbd50.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0404-9828-30 | 00404982830 | 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9828-30) / 30 mL in 1 VIAL, SINGLE-DOSE | 2022-01-09 | 0000-00-00 | No | No | Current |