Marcaine
- Product NDC
- 0404-9770
- 11-digit product format
- 004049770
- Labeler code
- 0404
- Product ID
- 0404-9770_dba40c2a-6967-4b86-a56d-e933f23f4ea3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- bupivacaine hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL
- Labeler
- Henry Schein, Inc.
- Application
- NDA016964
- Marketing category
- NDA
- Marketing start
- 2025-12-02
- 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
- Marcaine
- 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 |
| Rxcui | 1725078, 1725079 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0404-9770-10 | Marcaine | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 10 | | 1 |
| 0404-9770-10 | Marcaine | 1 in 1 BAG | INJECTION, SOLUTION | 1 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0404-9770-10 | 00404977010 | 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9770-10) / 10 mL in 1 VIAL, SINGLE-DOSE | 2025-12-02 | No | No | Historical |