Marcaine
- Product NDC
- 0409-2253
- 11-digit product format
- 004092253
- Labeler code
- 0409
- Product ID
- 0409-2253_94e0b63b-40eb-4cbf-ae95-99c429816d82
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- BUPIVACAINE HYDROCHLORIDE
- Dosage form
- INJECTION, SOLUTION
- Route
- EPIDURAL; RETROBULBAR
- Labeler
- Hospira, Inc.
- Application
- NDA016964
- Marketing category
- NDA
- Marketing start
- 2025-04-14
- Substance
- BUPIVACAINE HYDROCHLORIDE
- Active strength
- 225 mg/30mL
- Pharmacologic classes
- Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 7TQO7W3VT8 | BUPIVACAINE HYDROCHLORIDE | 73360-54-0 | BUPIVACAINE HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0409-2253-25 | 00409225325 | 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-2253-25) / 30 mL in 1 VIAL, SINGLE-DOSE (0409-2253-01) | 2025-04-14 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Marcaine | Hospira, Inc. | Pfizer Healthcare India Private Limited | 2026-04-23 | HUMAN PRESCRIPTION DRUG LABEL | 37 |
| Marcaine | Hospira, Inc. | Pfizer Healthcare India Private Limited | 2025-08-28 | HUMAN PRESCRIPTION DRUG LABEL | 35 |