Marcaine
- Product NDC
- 0362-0557
- 11-digit product format
- 003620557
- Labeler code
- 0362
- Product ID
- 0362-0557_2095bcd0-0dc6-4b6e-a86c-23140421e3d0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- bupivacaine hydrochloride and epinephrine bitartrate
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBMUCOSAL
- Labeler
- Septodont, Inc.
- Application
- ANDA077250
- Marketing category
- ANDA
- Marketing start
- 2018-06-12
- Substance
- BUPIVACAINE HYDROCHLORIDE ANHYDROUS; 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
- Marcaine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BUPIVACAINE HYDROCHLORIDE ANHYDROUS | 5 mg/mL |
| EPINEPHRINE BITARTRATE | .005 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | AKA908P8J1, 30Q7KI53AK |
| Rxcui | 1670365, 1673142 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0362-0557-05 | Marcaine | 50 in 1 CARTON | INJECTION, SOLUTION | 50 | | 5 |
| 0362-0557-05 | Marcaine | 1.8 mL in 1 CARTRIDGE | INJECTION, SOLUTION | 1.8 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0362-0557 | MARCAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [SEPTODONT, INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20240217_3e196aa4-0b01-44db-9267-98a995b54743.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 |
|---|
| 0362-0557-05 | 00362055705 | 50 CARTRIDGE in 1 CARTON (0362-0557-05) / 1.8 mL in 1 CARTRIDGE | 50 cartridge | 2018-06-12 | 0000-00-00 | No | No | Current |