Marcaine

Product NDC
0409-5010
11-digit product format
004095010
Labeler code
0409
Product ID
0409-5010_94e0b63b-40eb-4cbf-ae95-99c429816d82
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUPIVACAINE HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL; INTRACAUDAL; PERINEURAL
Labeler
Hospira, Inc.
Application
NDA016964
Marketing category
NDA
Marketing start
2025-02-03
Substance
BUPIVACAINE HYDROCHLORIDE
Active strength
50 mg/10mL
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 Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
7TQO7W3VT8BUPIVACAINE HYDROCHLORIDE73360-54-0BUPIVACAINE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0409-5010-250040950102525 VIAL, SINGLE-DOSE in 1 TRAY (0409-5010-25) / 10 mL in 1 VIAL, SINGLE-DOSE (0409-5010-01) 2025-02-03NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
MarcaineHospira, Inc. | Pfizer Healthcare India Private Limited2026-04-23HUMAN PRESCRIPTION DRUG LABEL37
MarcaineHospira, Inc. | Pfizer Healthcare India Private Limited2025-08-28HUMAN PRESCRIPTION DRUG LABEL35