MARCAINE WITH EPINEPHRINE
- Product NDC
- 0404-9908
- 11-digit product format
- 004049908
- Labeler code
- 0404
- Product ID
- 0404-9908_2950b33e-2ee2-4f43-9c08-3c5edef9caae
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- bupivacaine hydrochloride and epinephrine bitartrate
- Dosage form
- INJECTION, SOLUTION
- Route
- EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL
- Labeler
- Henry Schein, Inc.
- Application
- NDA016964
- Marketing category
- NDA
- Marketing start
- 2022-01-13
- Substance
- BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
- Active strength
- 2.5; .0091 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- MARCAINE WITH EPINEPHRINE
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BUPIVACAINE HYDROCHLORIDE | 2.5 mg/mL |
| EPINEPHRINE BITARTRATE | .0091 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7TQO7W3VT8, 30Q7KI53AK |
| Rxcui | 1867596 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0404-9908-30 | MARCAINE WITH EPINEPHRINE | 1 in 1 BAG | INJECTION, SOLUTION | 1 | | 7 |
| 0404-9908-30 | MARCAINE WITH EPINEPHRINE | 30 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 30 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0404-9908 | MARCAINE WITH EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HENRY SCHEIN, INC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20240323_d0d51133-882c-4f9e-ba1c-f037226305a1.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 |
|---|
| 0404-9908-30 | 00404990830 | 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9908-30) / 30 mL in 1 VIAL, SINGLE-DOSE | 2022-01-13 | 0000-00-00 | No | No | Current |