FDA.reportPublic FDA data

Marcaine

Product NDC
0409-2510
11-digit product format
004092510
Labeler code
0409
Product ID
0409-2510_94e0b63b-40eb-4cbf-ae95-99c429816d82
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUPIVACAINE HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL
Labeler
Hospira, Inc.
Application
NDA016964
Marketing category
NDA
Marketing start
2025-08-28
Substance
BUPIVACAINE HYDROCHLORIDE
Active strength
25 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

Additional Listing Data#

Finished product
Yes
Brand name base
Marcaine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPIVACAINE HYDROCHLORIDE25 mg/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7TQO7W3VT8, 30Q7KI53AK
Rxcui1012377, 1012381, 1012384, 1012388, 1012396, 1012400, 1012404, 1012406, 1672917, 1672919, 1673242, 1673243, 1724786, 1724787, 1724794, 1724796, 1724880, 1724884, 1725044, 1725046

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0b4ec9ca-d305-43fc-88dd-7a510313efe0Product name120260105
bb209f42-a85f-4fee-9d3d-c9dded168625Product name120251208
49628fc7-2031-4c28-bd31-0ef3aa8f44a3Product name320251118
cbf85893-59ef-423f-87d4-a573c000a8b9Product name820250731
b5b1095b-40cd-8a9e-b111-502545045b07Product name420250325
e190029e-423b-473c-8e04-2ada59b5b711Product name120250314
5dad6767-dcd1-b0da-8727-7f3f7bc3a435Product name220250303
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
e0031c74-3853-42bc-8e10-86dbbe83992eProduct name220231116
f7046b89-2016-499a-adc6-78479172abc6Product name120230425
e3a99641-4540-4894-9108-00cab3c57b7eProduct name120211207
5da98533-f072-406b-9e1b-6ac19eca9926Product name120210622
306b993e-3140-4823-ad5e-88b708f9d2acProduct name120210510
a831e694-3663-4a83-82be-6c309429f750Product name220200608
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
2686d634-e712-4007-8dbf-3d37c6c4d71fProduct name120181121
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
bd49bb86-2d32-4a7a-a594-eeda2e29af42Product name120180118
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
3becbe78-12d9-4ad2-9b4c-1e36f8d1303aProduct name120170815
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-2510-01Marcaine10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION1037
0409-2510-25Marcaine25 in 1 TRAYINJECTION, SOLUTION2537

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-2510-01ML - Milliliter0409-2510ffa8b7af-4e4f-474f-913b-d354e08d3f5912025-09-12
0409-2510-25ML - Milliliter0409-25106065e8bc-51ad-48c6-8993-01163093747f12025-09-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUPIVACAINE HYDROCHLORIDEACTIVE INGREDIENT7TQO7W3VT8MARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE WITH EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]13
EPINEPHRINE BITARTRATEACTIVE INGREDIENT30Q7KI53AKMARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE WITH EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]13
BUPIVACAINEACTIVE MOIETYY8335394ROMARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE WITH EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]13
EPINEPHRINEACTIVE MOIETYYKH834O4BHMARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE WITH EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]13
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RMARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE WITH EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]13
EDETATE CALCIUM DISODIUMINACTIVE INGREDIENT25IH6R4SGFMARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE WITH EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]13
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBMARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE WITH EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]13
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TMARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE WITH EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]13
MONOTHIOGLYCEROLINACTIVE INGREDIENTAAO1P0WSXJMARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE WITH EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]13
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XMARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE WITH EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]13
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IMARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE WITH EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]13
SODIUM LACTATEINACTIVE INGREDIENTTU7HW0W0QTMARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE WITH EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]13
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CMARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE WITH EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]13
WATERINACTIVE INGREDIENT059QF0KO0RMARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE WITH EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-2510MARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE WITH EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]33Current NDC, 2 package rows20250529_67578b56-7540-487e-1fba-481255620e78.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1867594BUPivacaine HCl 0.25 % / EPINEPHrine 1:200,000 in 10 ML InjectionPSN67578b56-7540-487e-1fba-481255620e7838
1867596BUPivacaine HCl 0.25 % / EPINEPHrine 1:200,000 in 30 ML InjectionPSN67578b56-7540-487e-1fba-481255620e7838
1012377BUPivacaine HCl 0.25 % / EPINEPHrine 1:200,000 Injectable SolutionPSN67578b56-7540-487e-1fba-481255620e7838
1725078BUPivacaine HCl 0.25 % in 10 ML InjectionPSN67578b56-7540-487e-1fba-481255620e7838
1725082BUPivacaine HCl 0.25 % in 30 ML InjectionPSN67578b56-7540-487e-1fba-481255620e7838
1012396BUPivacaine HCl 0.25 % Injectable SolutionPSN67578b56-7540-487e-1fba-481255620e7838
1672917BUPivacaine HCl 0.5 % / EPINEPHrine 1:200,000 in 10 ML InjectionPSN67578b56-7540-487e-1fba-481255620e7838
1672919BUPivacaine HCl 0.5 % / EPINEPHrine 1:200,000 in 30 ML InjectionPSN67578b56-7540-487e-1fba-481255620e7838
1012384BUPivacaine HCl 0.5 % / EPINEPHrine 1:200,000 Injectable SolutionPSN67578b56-7540-487e-1fba-481255620e7838
1724880BUPivacaine HCl 0.5 % in 10 ML InjectionPSN67578b56-7540-487e-1fba-481255620e7838
1724884BUPivacaine HCl 0.5 % in 30 ML InjectionPSN67578b56-7540-487e-1fba-481255620e7838
1012404BUPivacaine HCl 0.5 % Injectable SolutionPSN67578b56-7540-487e-1fba-481255620e7838
1724787BUPivacaine HCl 0.75 % in 10 ML InjectionPSN67578b56-7540-487e-1fba-481255620e7838
1724786BUPivacaine HCl 0.75 % in 30 ML InjectionPSN67578b56-7540-487e-1fba-481255620e7838
1867612Marcaine 0.25 % / EPINEPHrine 1:200,000 in 10 ML InjectionPSN67578b56-7540-487e-1fba-481255620e7838
1867614Marcaine 0.25 % / EPINEPHrine 1:200,000 in 30 ML InjectionPSN67578b56-7540-487e-1fba-481255620e7838
1012381Marcaine 0.25 % / EPINEPHrine 1:200,000 Injectable SolutionPSN67578b56-7540-487e-1fba-481255620e7838
1725079Marcaine 0.25 % in 10 ML InjectionPSN67578b56-7540-487e-1fba-481255620e7838
1725083Marcaine 0.25 % in 30 ML InjectionPSN67578b56-7540-487e-1fba-481255620e7838
1012400Marcaine 0.25 % Injectable SolutionPSN67578b56-7540-487e-1fba-481255620e7838
1673242Marcaine 0.5 % / EPINEPHrine 1:200,000 in 10 ML InjectionPSN67578b56-7540-487e-1fba-481255620e7838
1673243Marcaine 0.5 % / EPINEPHrine 1:200,000 in 30 ML InjectionPSN67578b56-7540-487e-1fba-481255620e7838
1012388Marcaine 0.5 % / EPINEPHrine 1:200,000 Injectable SolutionPSN67578b56-7540-487e-1fba-481255620e7838
1725044Marcaine 0.5 % in 10 ML InjectionPSN67578b56-7540-487e-1fba-481255620e7838
1725046Marcaine 0.5 % in 30 ML InjectionPSN67578b56-7540-487e-1fba-481255620e7838
1012406Marcaine 0.5 % Injectable SolutionPSN67578b56-7540-487e-1fba-481255620e7838
1724796Marcaine 0.75 % in 10 ML InjectionPSN67578b56-7540-487e-1fba-481255620e7838
1724794Marcaine 0.75 % in 30 ML InjectionPSN67578b56-7540-487e-1fba-481255620e7838
186761210 ML bupivacaine hydrochloride 2.5 MG/ML / epinephrine 0.005 MG/ML Injection [Marcaine with Epinephrine]SBD67578b56-7540-487e-1fba-481255620e7838
172507910 ML bupivacaine hydrochloride 2.5 MG/ML Injection [Marcaine]SBD67578b56-7540-487e-1fba-481255620e7838
167324210 ML bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML Injection [Marcaine with Epinephrine]SBD67578b56-7540-487e-1fba-481255620e7838
172504410 ML bupivacaine hydrochloride 5 MG/ML Injection [Marcaine]SBD67578b56-7540-487e-1fba-481255620e7838
172479610 ML bupivacaine hydrochloride 7.5 MG/ML Injection [Marcaine]SBD67578b56-7540-487e-1fba-481255620e7838
186761430 ML bupivacaine hydrochloride 2.5 MG/ML / epinephrine 0.005 MG/ML Injection [Marcaine with Epinephrine]SBD67578b56-7540-487e-1fba-481255620e7838
172508330 ML bupivacaine hydrochloride 2.5 MG/ML Injection [Marcaine]SBD67578b56-7540-487e-1fba-481255620e7838
167324330 ML bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML Injection [Marcaine with Epinephrine]SBD67578b56-7540-487e-1fba-481255620e7838
172504630 ML bupivacaine hydrochloride 5 MG/ML Injection [Marcaine]SBD67578b56-7540-487e-1fba-481255620e7838
172479430 ML bupivacaine hydrochloride 7.5 MG/ML Injection [Marcaine]SBD67578b56-7540-487e-1fba-481255620e7838
1012381bupivacaine hydrochloride 2.5 MG/ML / epinephrine 0.005 MG/ML Injectable Solution [Marcaine with Epinephrine]SBD67578b56-7540-487e-1fba-481255620e7838
1012400bupivacaine hydrochloride 2.5 MG/ML Injectable Solution [Marcaine]SBD67578b56-7540-487e-1fba-481255620e7838
1012388bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML Injectable Solution [Marcaine with Epinephrine]SBD67578b56-7540-487e-1fba-481255620e7838
1012406bupivacaine hydrochloride 5 MG/ML Injectable Solution [Marcaine]SBD67578b56-7540-487e-1fba-481255620e7838
186759410 ML bupivacaine hydrochloride 2.5 MG/ML / epinephrine 0.005 MG/ML InjectionSCD67578b56-7540-487e-1fba-481255620e7838
172507810 ML bupivacaine hydrochloride 2.5 MG/ML InjectionSCD67578b56-7540-487e-1fba-481255620e7838
167291710 ML bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML InjectionSCD67578b56-7540-487e-1fba-481255620e7838
172488010 ML bupivacaine hydrochloride 5 MG/ML InjectionSCD67578b56-7540-487e-1fba-481255620e7838
172478710 ML bupivacaine hydrochloride 7.5 MG/ML InjectionSCD67578b56-7540-487e-1fba-481255620e7838
186759630 ML bupivacaine hydrochloride 2.5 MG/ML / epinephrine 0.005 MG/ML InjectionSCD67578b56-7540-487e-1fba-481255620e7838
172508230 ML bupivacaine hydrochloride 2.5 MG/ML InjectionSCD67578b56-7540-487e-1fba-481255620e7838
167291930 ML bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML InjectionSCD67578b56-7540-487e-1fba-481255620e7838
172488430 ML bupivacaine hydrochloride 5 MG/ML InjectionSCD67578b56-7540-487e-1fba-481255620e7838
172478630 ML bupivacaine hydrochloride 7.5 MG/ML InjectionSCD67578b56-7540-487e-1fba-481255620e7838
1012377bupivacaine hydrochloride 2.5 MG/ML / epinephrine 0.005 MG/ML Injectable SolutionSCD67578b56-7540-487e-1fba-481255620e7838
1012396bupivacaine hydrochloride 2.5 MG/ML Injectable SolutionSCD67578b56-7540-487e-1fba-481255620e7838
1012384bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML Injectable SolutionSCD67578b56-7540-487e-1fba-481255620e7838
1012404bupivacaine hydrochloride 5 MG/ML Injectable SolutionSCD67578b56-7540-487e-1fba-481255620e7838
172507910 ML Marcaine 2.5 MG/ML InjectionSY67578b56-7540-487e-1fba-481255620e7838
172504410 ML Marcaine 5 MG/ML InjectionSY67578b56-7540-487e-1fba-481255620e7838
172479610 ML Marcaine 7.5 MG/ML InjectionSY67578b56-7540-487e-1fba-481255620e7838
172508330 ML Marcaine 2.5 MG/ML InjectionSY67578b56-7540-487e-1fba-481255620e7838
172504630 ML Marcaine 5 MG/ML InjectionSY67578b56-7540-487e-1fba-481255620e7838
172479430 ML Marcaine 7.5 MG/ML InjectionSY67578b56-7540-487e-1fba-481255620e7838
1867594bupivacaine HCl 0.25 % / epinephrine (as bitartrate) 1:200,000 per 10 mL InjectionSY67578b56-7540-487e-1fba-481255620e7838
1867596bupivacaine HCl 0.25 % / epinephrine 1:200,000 per 30 ML InjectionSY67578b56-7540-487e-1fba-481255620e7838
1725078bupivacaine HCl 0.25 % in 10 ML InjectionSY67578b56-7540-487e-1fba-481255620e7838
1725082bupivacaine HCl 0.25 % per 30 ML InjectionSY67578b56-7540-487e-1fba-481255620e7838
1672917bupivacaine HCl 0.5 % / epinephrine (as bitartrate) 1:200,000 per 10 ML InjectionSY67578b56-7540-487e-1fba-481255620e7838
1672919bupivacaine HCl 0.5 % / epinephrine (as bitartrate) 1:200,000 per 30 ML InjectionSY67578b56-7540-487e-1fba-481255620e7838
1724880bupivacaine HCl 0.5 % in 10 ML InjectionSY67578b56-7540-487e-1fba-481255620e7838
1724884bupivacaine HCl 0.5 % in 30 ML InjectionSY67578b56-7540-487e-1fba-481255620e7838
1724787bupivacaine HCl 0.75 % in 10 ML InjectionSY67578b56-7540-487e-1fba-481255620e7838
1724786bupivacaine HCl 0.75 % in 30 ML InjectionSY67578b56-7540-487e-1fba-481255620e7838
1724786bupivacaine HCl 225 MG per 30 ML InjectionSY67578b56-7540-487e-1fba-481255620e7838
1724787bupivacaine HCl 75 MG per 10 ML InjectionSY67578b56-7540-487e-1fba-481255620e7838
1012377bupivacaine hydrochloride 0.25 % / epinephrine (as epinephrine bitartrate) 1:200,000 Injectable SolutionSY67578b56-7540-487e-1fba-481255620e7838
1012396bupivacaine hydrochloride 0.25 % Injectable SolutionSY67578b56-7540-487e-1fba-481255620e7838
1012384bupivacaine hydrochloride 0.5 % / epinephrine (as epinephrine bitartrate) 1:200,000 Injectable SolutionSY67578b56-7540-487e-1fba-481255620e7838
1012404bupivacaine hydrochloride 0.5 % Injectable SolutionSY67578b56-7540-487e-1fba-481255620e7838
1867614Marcaine 0.25 % / epinephrine (as epinephrine bitartrate) 1:200,000 per 30 ML InjectionSY67578b56-7540-487e-1fba-481255620e7838
1012381Marcaine 0.25 % / epinephrine 1:200,000 Injectable SolutionSY67578b56-7540-487e-1fba-481255620e7838

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0409-2510-010040925100110 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical
0409-2510-250040925102525 VIAL, SINGLE-DOSE in 1 TRAY (0409-2510-25) / 10 mL in 1 VIAL, SINGLE-DOSE (0409-2510-01) 2025-08-28NoNoHistorical