FDA.reportPublic FDA data

Marcaine with Epinephrine

Product NDC
0409-1541
11-digit product format
004091541
Labeler code
0409
Product ID
0409-1541_14ec85dc-0263-44d1-9267-66fa072cff8d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL
Labeler
Hospira, Inc.
Application
NDA016964
Marketing category
NDA
Marketing start
2022-09-06
Substance
BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
Active strength
2.5; .0091 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 with Epinephrine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPIVACAINE HYDROCHLORIDE2.5 mg/mL
EPINEPHRINE BITARTRATE.0091 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii30Q7KI53AK, 7TQO7W3VT8
Rxcui1012377, 1012381, 1012384, 1012388, 1672917, 1672919, 1673242, 1673243, 1867594, 1867596, 1867612, 1867614

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
0409-1541-01Marcaine with Epinephrine30 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION305
0409-1541-10Marcaine with Epinephrine10 in 1 CARTONINJECTION, SOLUTION105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-1541-01ML - Milliliter0409-1541a191f1f0-f3e2-4ac6-8c16-adb7e040a2ec12022-10-06
0409-1541-10ML - Milliliter0409-1541d51a1bf6-c7e2-4f12-b465-5e7d037a249712022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-1541MARCAINE WITH EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE) INJECTION, SOLUTION [HOSPIRA, INC.]5Current NDC, Legacy NDC, 2 package rows20240203_93cf0914-de08-4ec6-8f8c-d663243b9958.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1867594BUPivacaine HCl 0.25 % / EPINEPHrine 1:200,000 in 10 ML InjectionPSN93cf0914-de08-4ec6-8f8c-d663243b99585
1867596BUPivacaine HCl 0.25 % / EPINEPHrine 1:200,000 in 30 ML InjectionPSN93cf0914-de08-4ec6-8f8c-d663243b99585
1012377BUPivacaine HCl 0.25 % / EPINEPHrine 1:200,000 Injectable SolutionPSN93cf0914-de08-4ec6-8f8c-d663243b99585
1672917BUPivacaine HCl 0.5 % / EPINEPHrine 1:200,000 in 10 ML InjectionPSN93cf0914-de08-4ec6-8f8c-d663243b99585
1672919BUPivacaine HCl 0.5 % / EPINEPHrine 1:200,000 in 30 ML InjectionPSN93cf0914-de08-4ec6-8f8c-d663243b99585
1012384BUPivacaine HCl 0.5 % / EPINEPHrine 1:200,000 Injectable SolutionPSN93cf0914-de08-4ec6-8f8c-d663243b99585
1867612Marcaine 0.25 % / EPINEPHrine 1:200,000 in 10 ML InjectionPSN93cf0914-de08-4ec6-8f8c-d663243b99585
1867614Marcaine 0.25 % / EPINEPHrine 1:200,000 in 30 ML InjectionPSN93cf0914-de08-4ec6-8f8c-d663243b99585
1012381Marcaine 0.25 % / EPINEPHrine 1:200,000 Injectable SolutionPSN93cf0914-de08-4ec6-8f8c-d663243b99585
1673242Marcaine 0.5 % / EPINEPHrine 1:200,000 in 10 ML InjectionPSN93cf0914-de08-4ec6-8f8c-d663243b99585
1673243Marcaine 0.5 % / EPINEPHrine 1:200,000 in 30 ML InjectionPSN93cf0914-de08-4ec6-8f8c-d663243b99585
1012388Marcaine 0.5 % / EPINEPHrine 1:200,000 Injectable SolutionPSN93cf0914-de08-4ec6-8f8c-d663243b99585
186761210 ML bupivacaine hydrochloride 2.5 MG/ML / epinephrine 0.005 MG/ML Injection [Marcaine with Epinephrine]SBD93cf0914-de08-4ec6-8f8c-d663243b99585
167324210 ML bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML Injection [Marcaine with Epinephrine]SBD93cf0914-de08-4ec6-8f8c-d663243b99585
186761430 ML bupivacaine hydrochloride 2.5 MG/ML / epinephrine 0.005 MG/ML Injection [Marcaine with Epinephrine]SBD93cf0914-de08-4ec6-8f8c-d663243b99585
167324330 ML bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML Injection [Marcaine with Epinephrine]SBD93cf0914-de08-4ec6-8f8c-d663243b99585
1012381bupivacaine hydrochloride 2.5 MG/ML / epinephrine 0.005 MG/ML Injectable Solution [Marcaine with Epinephrine]SBD93cf0914-de08-4ec6-8f8c-d663243b99585
1012388bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML Injectable Solution [Marcaine with Epinephrine]SBD93cf0914-de08-4ec6-8f8c-d663243b99585
186759410 ML bupivacaine hydrochloride 2.5 MG/ML / epinephrine 0.005 MG/ML InjectionSCD93cf0914-de08-4ec6-8f8c-d663243b99585
167291710 ML bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML InjectionSCD93cf0914-de08-4ec6-8f8c-d663243b99585
186759630 ML bupivacaine hydrochloride 2.5 MG/ML / epinephrine 0.005 MG/ML InjectionSCD93cf0914-de08-4ec6-8f8c-d663243b99585
167291930 ML bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML InjectionSCD93cf0914-de08-4ec6-8f8c-d663243b99585
1012377bupivacaine hydrochloride 2.5 MG/ML / epinephrine 0.005 MG/ML Injectable SolutionSCD93cf0914-de08-4ec6-8f8c-d663243b99585
1012384bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML Injectable SolutionSCD93cf0914-de08-4ec6-8f8c-d663243b99585
1867594bupivacaine HCl 0.25 % / epinephrine (as bitartrate) 1:200,000 per 10 mL InjectionSY93cf0914-de08-4ec6-8f8c-d663243b99585
1867596bupivacaine HCl 0.25 % / epinephrine 1:200,000 per 30 ML InjectionSY93cf0914-de08-4ec6-8f8c-d663243b99585
1672917bupivacaine HCl 0.5 % / epinephrine (as bitartrate) 1:200,000 per 10 ML InjectionSY93cf0914-de08-4ec6-8f8c-d663243b99585
1672919bupivacaine HCl 0.5 % / epinephrine (as bitartrate) 1:200,000 per 30 ML InjectionSY93cf0914-de08-4ec6-8f8c-d663243b99585
1012377bupivacaine hydrochloride 0.25 % / epinephrine (as epinephrine bitartrate) 1:200,000 Injectable SolutionSY93cf0914-de08-4ec6-8f8c-d663243b99585
1012384bupivacaine hydrochloride 0.5 % / epinephrine (as epinephrine bitartrate) 1:200,000 Injectable SolutionSY93cf0914-de08-4ec6-8f8c-d663243b99585
1867614Marcaine 0.25 % / epinephrine (as epinephrine bitartrate) 1:200,000 per 30 ML InjectionSY93cf0914-de08-4ec6-8f8c-d663243b99585
1012381Marcaine 0.25 % / epinephrine 1:200,000 Injectable SolutionSY93cf0914-de08-4ec6-8f8c-d663243b99585
1867612Marcaine 0.25 % / EPINEPHrine 1:200,000 per 10 ML InjectionSY93cf0914-de08-4ec6-8f8c-d663243b99585
1673242Marcaine 0.5 % / epinephrine (as bitartrate) 1:200,000 in 10 ML InjectionSY93cf0914-de08-4ec6-8f8c-d663243b99585
1673243Marcaine 0.5 % / epinephrine (as bitartrate) 1:200,000 per 30 ML InjectionSY93cf0914-de08-4ec6-8f8c-d663243b99585
1012388Marcaine 0.5 % / epinephrine 1:200,000 Injectable SolutionSY93cf0914-de08-4ec6-8f8c-d663243b99585
1012381Marcaine with Epinephrine 0.25/1:200000 (bupivacaine hydrochloride / epinephrine (as bitartrate) ) Injectable SolutionSY93cf0914-de08-4ec6-8f8c-d663243b99585
1012388Marcaine with Epinephrine 0.5/1:200000 (bupivacaine hydrochloride / epinephrine (as epinephrine bitartrate) ) Injectable SolutionSY93cf0914-de08-4ec6-8f8c-d663243b99585

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-1541-010040915410130 mL in 1 VIAL, SINGLE-DOSE30 mlHistorical
0409-1541-100040915411010 VIAL, SINGLE-DOSE in 1 CARTON (0409-1541-10) / 30 mL in 1 VIAL, SINGLE-DOSE (0409-1541-01) 2022-09-060000-00-00NoNoCurrent