FDA.reportPublic FDA data

Marcaine Spinal

Product NDC
0409-1761
11-digit product format
004091761
Labeler code
0409
Product ID
0409-1761_f3862f77-3621-4730-923e-9efbfa18e03f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupivacaine Hydrochloride in Dextrose
Dosage form
INJECTION, SOLUTION
Route
SUBARACHNOID
Labeler
Hospira, Inc.
Application
NDA018692
Marketing category
NDA
Marketing start
2005-05-19
Substance
BUPIVACAINE HYDROCHLORIDE
Active strength
7.5 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 Spinal
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPIVACAINE HYDROCHLORIDE7.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7TQO7W3VT8
Rxcui1724784, 1724792

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
0b4ec9ca-d305-43fc-88dd-7a510313efe0Product name120260105
bb209f42-a85f-4fee-9d3d-c9dded168625Product name120251208
49628fc7-2031-4c28-bd31-0ef3aa8f44a3Product name320251118
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
cbf85893-59ef-423f-87d4-a573c000a8b9Product name820250731
b5b1095b-40cd-8a9e-b111-502545045b07Product name420250325
e190029e-423b-473c-8e04-2ada59b5b711Product name120250314
5dad6767-dcd1-b0da-8727-7f3f7bc3a435Product name220250303
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
e0031c74-3853-42bc-8e10-86dbbe83992eProduct name220231116
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
f7046b89-2016-499a-adc6-78479172abc6Product name120230425
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
e3a99641-4540-4894-9108-00cab3c57b7eProduct name120211207
5da98533-f072-406b-9e1b-6ac19eca9926Product name120210622
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
306b993e-3140-4823-ad5e-88b708f9d2acProduct name120210510
a831e694-3663-4a83-82be-6c309429f750Product name220200608
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
2686d634-e712-4007-8dbf-3d37c6c4d71fProduct name120181121
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
bd49bb86-2d32-4a7a-a594-eeda2e29af42Product name120180118
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
3becbe78-12d9-4ad2-9b4c-1e36f8d1303aProduct name120170815
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-1761-02Marcaine Spinal1 in 1 DOSE PACKINJECTION, SOLUTION126
0409-1761-02Marcaine Spinal10 in 1 CARTONINJECTION, SOLUTION1026
0409-1761-05Marcaine Spinal5 in 1 CELLO PACKINJECTION, SOLUTION526
0409-1761-10Marcaine Spinal2 in 1 CARTONINJECTION, SOLUTION226
0409-1761-18Marcaine Spinal2 mL in 1 AMPULEINJECTION, SOLUTION226
0409-1761-19Marcaine Spinal2 mL in 1 AMPULEINJECTION, SOLUTION226
0409-1761-62Marcaine Spinal800 in 1 CASEINJECTION, SOLUTION80026

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-1761-02ML - Milliliter0409-1761d33dbc93-d8f8-4be6-b9ef-991dec424e9412012-07-24
0409-1761-05ML - Milliliter0409-17615723fb98-b0de-4b14-ab1a-d9c14c1004fc12022-09-12
0409-1761-10ML - Milliliter0409-17615030823e-621f-489e-b523-383d393f1f4012022-09-12
0409-1761-18ML - Milliliter0409-17611673960f-94c8-4c84-9dc5-04df83c8352512018-04-19
0409-1761-19ML - Milliliter0409-17617406e6d9-5377-438d-acb4-03cf6851cff012017-07-07
0409-1761-62ML - Milliliter0409-1761528c8fc8-d205-4c5e-acb6-aa7bf44041e212017-09-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUPIVACAINE HYDROCHLORIDEACTIVE INGREDIENT7TQO7W3VT8MARCAINE SPINAL (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.]15
BUPIVACAINEACTIVE MOIETYY8335394ROMARCAINE SPINAL (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.]15
ANHYDROUS DEXTROSEINACTIVE INGREDIENT5SL0G7R0OKMARCAINE SPINAL (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.]15
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBMARCAINE SPINAL (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.]15
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IMARCAINE SPINAL (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.]15
BUPIVACAINE HYDROCHLORIDEACTIVE INGREDIENT7TQO7W3VT8V49663C-25 SPINAL 25G PENCIL POINT NOVAPLUS () C47916 [SMITHS MEDICAL ASD, INC.]1
EPINEPHRINEACTIVE INGREDIENTYKH834O4BHV49663C-25 SPINAL 25G PENCIL POINT NOVAPLUS () C47916 [SMITHS MEDICAL ASD, INC.]1
LIDOCAINE HYDROCHLORIDE ANHYDROUSACTIVE INGREDIENTEC2CNF7XFPV49663C-25 SPINAL 25G PENCIL POINT NOVAPLUS () C47916 [SMITHS MEDICAL ASD, INC.]1
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99MV49663C-25 SPINAL 25G PENCIL POINT NOVAPLUS () C47916 [SMITHS MEDICAL ASD, INC.]1
BUPIVACAINEACTIVE MOIETYY8335394ROV49663C-25 SPINAL 25G PENCIL POINT NOVAPLUS () C47916 [SMITHS MEDICAL ASD, INC.]1
EPINEPHRINEACTIVE MOIETYYKH834O4BHV49663C-25 SPINAL 25G PENCIL POINT NOVAPLUS () C47916 [SMITHS MEDICAL ASD, INC.]1
IODINEACTIVE MOIETY9679TC07X4V49663C-25 SPINAL 25G PENCIL POINT NOVAPLUS () C47916 [SMITHS MEDICAL ASD, INC.]1
LidocaineACTIVE MOIETY98PI200987V49663C-25 SPINAL 25G PENCIL POINT NOVAPLUS () C47916 [SMITHS MEDICAL ASD, INC.]1
ANHYDROUS DEXTROSEINACTIVE INGREDIENT5SL0G7R0OKV49663C-25 SPINAL 25G PENCIL POINT NOVAPLUS () C47916 [SMITHS MEDICAL ASD, INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPV49663C-25 SPINAL 25G PENCIL POINT NOVAPLUS () C47916 [SMITHS MEDICAL ASD, INC.]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBV49663C-25 SPINAL 25G PENCIL POINT NOVAPLUS () C47916 [SMITHS MEDICAL ASD, INC.]1
NONOXYNOL-9INACTIVE INGREDIENT48Q180SH9TV49663C-25 SPINAL 25G PENCIL POINT NOVAPLUS () C47916 [SMITHS MEDICAL ASD, INC.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XV49663C-25 SPINAL 25G PENCIL POINT NOVAPLUS () C47916 [SMITHS MEDICAL ASD, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IV49663C-25 SPINAL 25G PENCIL POINT NOVAPLUS () C47916 [SMITHS MEDICAL ASD, INC.]1
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CV49663C-25 SPINAL 25G PENCIL POINT NOVAPLUS () C47916 [SMITHS MEDICAL ASD, INC.]1
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74V49663C-25 SPINAL 25G PENCIL POINT NOVAPLUS () C47916 [SMITHS MEDICAL ASD, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RV49663C-25 SPINAL 25G PENCIL POINT NOVAPLUS () C47916 [SMITHS MEDICAL ASD, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-1761MARCAINE SPINAL (BUPIVACAINE HYDROCHLORIDE IN DEXTROSE) INJECTION, SOLUTION [HOSPIRA, INC.]26Current NDC, Legacy NDC, 7 package rows20250515_9679cc05-2f8a-4e88-53b5-6e9122c8b8c0.zip
0409-1761V49663C-25 SPINAL 25G PENCIL POINT NOVAPLUS () C47916 [SMITHS MEDICAL ASD, INC.]2Current NDC, Legacy NDC20200401_6e04f24a-a4ca-4e84-b3b3-7deba0b9cad0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1724784BUPivacaine HCl 0.75 % in 2 ML InjectionPSN9679cc05-2f8a-4e88-53b5-6e9122c8b8c026
1724792Marcaine 0.75 % in 2 ML InjectionPSN9679cc05-2f8a-4e88-53b5-6e9122c8b8c026
17247922 ML bupivacaine hydrochloride 7.5 MG/ML Injection [Marcaine]SBD9679cc05-2f8a-4e88-53b5-6e9122c8b8c026
17247842 ML bupivacaine hydrochloride 7.5 MG/ML InjectionSCD9679cc05-2f8a-4e88-53b5-6e9122c8b8c026
17247922 ML Marcaine 7.5 MG/ML InjectionSY9679cc05-2f8a-4e88-53b5-6e9122c8b8c026
1724784bupivacaine HCl 0.75 % per 2 ML InjectionSY9679cc05-2f8a-4e88-53b5-6e9122c8b8c026
1724784bupivacaine HCl 15 MG per 2 ML InjectionSY9679cc05-2f8a-4e88-53b5-6e9122c8b8c026
1724792Marcaine 0.75 % in 2 ML InjectionSY9679cc05-2f8a-4e88-53b5-6e9122c8b8c026
1724792Marcaine 15 MG per 2 ML InjectionSY9679cc05-2f8a-4e88-53b5-6e9122c8b8c026
1724784BUPivacaine HCl 0.75 % in 2 ML InjectionPSN6e04f24a-a4ca-4e84-b3b3-7deba0b9cad02
1660014EPINEPHrine 1 MG in 1 ML InjectionPSN6e04f24a-a4ca-4e84-b3b3-7deba0b9cad02
1737568lidocaine HCl 1 % in 2 ML InjectionPSN6e04f24a-a4ca-4e84-b3b3-7deba0b9cad02
1737566lidocaine HCl 1 % in 5 ML InjectionPSN6e04f24a-a4ca-4e84-b3b3-7deba0b9cad02
1724792Marcaine 0.75 % in 2 ML InjectionPSN6e04f24a-a4ca-4e84-b3b3-7deba0b9cad02
312564povidone-iodine 10 % Topical SolutionPSN6e04f24a-a4ca-4e84-b3b3-7deba0b9cad02
17247922 ML bupivacaine hydrochloride 7.5 MG/ML Injection [Marcaine]SBD6e04f24a-a4ca-4e84-b3b3-7deba0b9cad02
16600141 ML epinephrine 1 MG/ML InjectionSCD6e04f24a-a4ca-4e84-b3b3-7deba0b9cad02
17247842 ML bupivacaine hydrochloride 7.5 MG/ML InjectionSCD6e04f24a-a4ca-4e84-b3b3-7deba0b9cad02
17375682 ML lidocaine hydrochloride 10 MG/ML InjectionSCD6e04f24a-a4ca-4e84-b3b3-7deba0b9cad02
17375665 ML lidocaine hydrochloride 10 MG/ML InjectionSCD6e04f24a-a4ca-4e84-b3b3-7deba0b9cad02
312564povidone-iodine 100 MG/ML Topical SolutionSCD6e04f24a-a4ca-4e84-b3b3-7deba0b9cad02
17247922 ML Marcaine 7.5 MG/ML InjectionSY6e04f24a-a4ca-4e84-b3b3-7deba0b9cad02
1724784bupivacaine HCl 0.75 % per 2 ML InjectionSY6e04f24a-a4ca-4e84-b3b3-7deba0b9cad02
1724784bupivacaine HCl 15 MG per 2 ML InjectionSY6e04f24a-a4ca-4e84-b3b3-7deba0b9cad02
1660014epinephrine 1 MG per 1 ML InjectionSY6e04f24a-a4ca-4e84-b3b3-7deba0b9cad02
1737568lidocaine HCl 1 % per 2 ML InjectionSY6e04f24a-a4ca-4e84-b3b3-7deba0b9cad02
1737566lidocaine HCl 1 % per 5 ML InjectionSY6e04f24a-a4ca-4e84-b3b3-7deba0b9cad02
1737568lidocaine HCl 20 MG per 2 ML InjectionSY6e04f24a-a4ca-4e84-b3b3-7deba0b9cad02
1737566lidocaine HCl 50 MG per 5 ML InjectionSY6e04f24a-a4ca-4e84-b3b3-7deba0b9cad02
1724792Marcaine 0.75 % in 2 ML InjectionSY6e04f24a-a4ca-4e84-b3b3-7deba0b9cad02
1724792Marcaine 15 MG per 2 ML InjectionSY6e04f24a-a4ca-4e84-b3b3-7deba0b9cad02
312564povidone-iodine 10 % (titratable iodine 1 % ) Topical SolutionSY6e04f24a-a4ca-4e84-b3b3-7deba0b9cad02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-1761-020040917610210 DOSE PACK in 1 CARTON (0409-1761-02) > 1 AMPULE in 1 DOSE PACK > 2 mL in 1 AMPULE (0409-1761-19) 10 dose pack2005-06-160000-00-00NoNoCurrent
0409-1761-05004091761055 in 1 CELLO PACKHistorical
0409-1761-10004091761102 CELLO PACK in 1 CARTON (0409-1761-10) / 5 AMPULE in 1 CELLO PACK (0409-1761-05) / 2 mL in 1 AMPULE (0409-1761-18) 2 cello pack2022-08-010000-00-00NoNoCurrent
0409-1761-18004091761182 mL in 1 AMPULE2 mlHistorical
0409-1761-19004091761192 mL in 1 AMPULE2 mlHistorical
0409-1761-6200409176162800 AMPULE in 1 CASE (0409-1761-62) / 2 mL in 1 AMPULE (0409-1761-18) 800 ampule2005-05-190000-00-00NoNoCurrent