FDA.reportPublic FDA data

Bupivacaine Hydrochloride

Product NDC
0409-1163
11-digit product format
004091163
Labeler code
0409
Product ID
0409-1163_6e442bfd-d3da-4913-8585-ce3485644364
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUPIVACAINE HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
PERINEURAL
Labeler
Hospira, Inc.
Application
ANDA070597
Marketing category
ANDA
Marketing start
2005-03-31
Substance
BUPIVACAINE HYDROCHLORIDE
Active strength
5 mg/mL
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
Bupivacaine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPIVACAINE HYDROCHLORIDE5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii30Q7KI53AK, 7TQO7W3VT8
Rxcui1012377, 1012384, 1012396, 1012404, 1672917, 1672919, 1724786, 1724787, 1724880, 1724884, 1725078, 1725082, 1867594, 1867596

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
e0031c74-3853-42bc-8e10-86dbbe83992eProduct name220231116
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
f7046b89-2016-499a-adc6-78479172abc6Product name120230425
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
e3a99641-4540-4894-9108-00cab3c57b7eProduct name120211207
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
5da98533-f072-406b-9e1b-6ac19eca9926Product name120210622
306b993e-3140-4823-ad5e-88b708f9d2acProduct name120210510
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
a831e694-3663-4a83-82be-6c309429f750Product name220200608
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
2686d634-e712-4007-8dbf-3d37c6c4d71fProduct name120181121
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
bd49bb86-2d32-4a7a-a594-eeda2e29af42Product name120180118
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
3becbe78-12d9-4ad2-9b4c-1e36f8d1303aProduct name120170815
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-1163-01Bupivacaine Hydrochloride25 in 1 TRAYINJECTION, SOLUTION2539
0409-1163-18Bupivacaine Hydrochloride50 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION5039

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-1163-01ML - Milliliter0409-11632a069acd-3101-40a8-9726-c015a1de728812012-07-24
0409-1163-18ML - Milliliter0409-1163678a596a-2326-45e5-92e0-3a1dbebb3ec712017-07-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUPIVACAINE HYDROCHLORIDEACTIVE INGREDIENT7TQO7W3VT8BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]18
EPINEPHRINE BITARTRATEACTIVE INGREDIENT30Q7KI53AKBUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]18
BUPIVACAINEACTIVE MOIETYY8335394ROBUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]18
EPINEPHRINEACTIVE MOIETYYKH834O4BHBUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]18
EDETATE CALCIUM DISODIUM ANHYDROUSINACTIVE INGREDIENT8U5D034955BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]18
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBBUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]18
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TBUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]18
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XBUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]18
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IBUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]18
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CBUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]18
WATERINACTIVE INGREDIENT059QF0KO0RBUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-1163BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION [HOSPIRA, INC.]38Current NDC, Legacy NDC, 2 package rows20241017_02a845c3-4521-4926-e397-25ab536e7cf6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1867594BUPivacaine HCl 0.25 % / EPINEPHrine 1:200,000 in 10 ML InjectionPSN02a845c3-4521-4926-e397-25ab536e7cf639
1867596BUPivacaine HCl 0.25 % / EPINEPHrine 1:200,000 in 30 ML InjectionPSN02a845c3-4521-4926-e397-25ab536e7cf639
1012377BUPivacaine HCl 0.25 % / EPINEPHrine 1:200,000 Injectable SolutionPSN02a845c3-4521-4926-e397-25ab536e7cf639
1725078BUPivacaine HCl 0.25 % in 10 ML InjectionPSN02a845c3-4521-4926-e397-25ab536e7cf639
1725082BUPivacaine HCl 0.25 % in 30 ML InjectionPSN02a845c3-4521-4926-e397-25ab536e7cf639
1012396BUPivacaine HCl 0.25 % Injectable SolutionPSN02a845c3-4521-4926-e397-25ab536e7cf639
1672917BUPivacaine HCl 0.5 % / EPINEPHrine 1:200,000 in 10 ML InjectionPSN02a845c3-4521-4926-e397-25ab536e7cf639
1672919BUPivacaine HCl 0.5 % / EPINEPHrine 1:200,000 in 30 ML InjectionPSN02a845c3-4521-4926-e397-25ab536e7cf639
1012384BUPivacaine HCl 0.5 % / EPINEPHrine 1:200,000 Injectable SolutionPSN02a845c3-4521-4926-e397-25ab536e7cf639
1724880BUPivacaine HCl 0.5 % in 10 ML InjectionPSN02a845c3-4521-4926-e397-25ab536e7cf639
1724884BUPivacaine HCl 0.5 % in 30 ML InjectionPSN02a845c3-4521-4926-e397-25ab536e7cf639
1012404BUPivacaine HCl 0.5 % Injectable SolutionPSN02a845c3-4521-4926-e397-25ab536e7cf639
1724787BUPivacaine HCl 0.75 % in 10 ML InjectionPSN02a845c3-4521-4926-e397-25ab536e7cf639
1724786BUPivacaine HCl 0.75 % in 30 ML InjectionPSN02a845c3-4521-4926-e397-25ab536e7cf639
186759410 ML bupivacaine hydrochloride 2.5 MG/ML / epinephrine 0.005 MG/ML InjectionSCD02a845c3-4521-4926-e397-25ab536e7cf639
172507810 ML bupivacaine hydrochloride 2.5 MG/ML InjectionSCD02a845c3-4521-4926-e397-25ab536e7cf639
167291710 ML bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML InjectionSCD02a845c3-4521-4926-e397-25ab536e7cf639
172488010 ML bupivacaine hydrochloride 5 MG/ML InjectionSCD02a845c3-4521-4926-e397-25ab536e7cf639
172478710 ML bupivacaine hydrochloride 7.5 MG/ML InjectionSCD02a845c3-4521-4926-e397-25ab536e7cf639
186759630 ML bupivacaine hydrochloride 2.5 MG/ML / epinephrine 0.005 MG/ML InjectionSCD02a845c3-4521-4926-e397-25ab536e7cf639
172508230 ML bupivacaine hydrochloride 2.5 MG/ML InjectionSCD02a845c3-4521-4926-e397-25ab536e7cf639
167291930 ML bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML InjectionSCD02a845c3-4521-4926-e397-25ab536e7cf639
172488430 ML bupivacaine hydrochloride 5 MG/ML InjectionSCD02a845c3-4521-4926-e397-25ab536e7cf639
172478630 ML bupivacaine hydrochloride 7.5 MG/ML InjectionSCD02a845c3-4521-4926-e397-25ab536e7cf639
1012377bupivacaine hydrochloride 2.5 MG/ML / epinephrine 0.005 MG/ML Injectable SolutionSCD02a845c3-4521-4926-e397-25ab536e7cf639
1012396bupivacaine hydrochloride 2.5 MG/ML Injectable SolutionSCD02a845c3-4521-4926-e397-25ab536e7cf639
1012384bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML Injectable SolutionSCD02a845c3-4521-4926-e397-25ab536e7cf639
1012404bupivacaine hydrochloride 5 MG/ML Injectable SolutionSCD02a845c3-4521-4926-e397-25ab536e7cf639
1867594bupivacaine HCl 0.25 % / epinephrine (as bitartrate) 1:200,000 per 10 mL InjectionSY02a845c3-4521-4926-e397-25ab536e7cf639
1867596bupivacaine HCl 0.25 % / epinephrine 1:200,000 per 30 ML InjectionSY02a845c3-4521-4926-e397-25ab536e7cf639
1725078bupivacaine HCl 0.25 % in 10 ML InjectionSY02a845c3-4521-4926-e397-25ab536e7cf639
1725082bupivacaine HCl 0.25 % per 30 ML InjectionSY02a845c3-4521-4926-e397-25ab536e7cf639
1672917bupivacaine HCl 0.5 % / epinephrine (as bitartrate) 1:200,000 per 10 ML InjectionSY02a845c3-4521-4926-e397-25ab536e7cf639
1672919bupivacaine HCl 0.5 % / epinephrine (as bitartrate) 1:200,000 per 30 ML InjectionSY02a845c3-4521-4926-e397-25ab536e7cf639
1724880bupivacaine HCl 0.5 % in 10 ML InjectionSY02a845c3-4521-4926-e397-25ab536e7cf639
1724884bupivacaine HCl 0.5 % in 30 ML InjectionSY02a845c3-4521-4926-e397-25ab536e7cf639
1724787bupivacaine HCl 0.75 % in 10 ML InjectionSY02a845c3-4521-4926-e397-25ab536e7cf639
1724786bupivacaine HCl 0.75 % in 30 ML InjectionSY02a845c3-4521-4926-e397-25ab536e7cf639
1724786bupivacaine HCl 225 MG per 30 ML InjectionSY02a845c3-4521-4926-e397-25ab536e7cf639
1724787bupivacaine HCl 75 MG per 10 ML InjectionSY02a845c3-4521-4926-e397-25ab536e7cf639
1012377bupivacaine hydrochloride 0.25 % / epinephrine (as epinephrine bitartrate) 1:200,000 Injectable SolutionSY02a845c3-4521-4926-e397-25ab536e7cf639
1012396bupivacaine hydrochloride 0.25 % Injectable SolutionSY02a845c3-4521-4926-e397-25ab536e7cf639
1012384bupivacaine hydrochloride 0.5 % / epinephrine (as epinephrine bitartrate) 1:200,000 Injectable SolutionSY02a845c3-4521-4926-e397-25ab536e7cf639
1012404bupivacaine hydrochloride 0.5 % Injectable SolutionSY02a845c3-4521-4926-e397-25ab536e7cf639
1012396BUPivacaine HCl 0.25 % Injectable SolutionPSN950d82b6-76a1-0c08-e053-2a95a90a3a9211
1012404BUPivacaine HCl 0.5 % Injectable SolutionPSN950d82b6-76a1-0c08-e053-2a95a90a3a9211
1012396bupivacaine hydrochloride 2.5 MG/ML Injectable SolutionSCD950d82b6-76a1-0c08-e053-2a95a90a3a9211
1012404bupivacaine hydrochloride 5 MG/ML Injectable SolutionSCD950d82b6-76a1-0c08-e053-2a95a90a3a9211
1012396bupivacaine hydrochloride 0.25 % Injectable SolutionSY950d82b6-76a1-0c08-e053-2a95a90a3a9211
1012404bupivacaine hydrochloride 0.5 % Injectable SolutionSY950d82b6-76a1-0c08-e053-2a95a90a3a9211
1012404BUPivacaine HCl 0.5 % Injectable SolutionPSN496ccd9e-d1c3-4b5a-93b6-0c457faa15896
1012404bupivacaine hydrochloride 5 MG/ML Injectable SolutionSCD496ccd9e-d1c3-4b5a-93b6-0c457faa15896
1012404bupivacaine hydrochloride 0.5 % Injectable SolutionSY496ccd9e-d1c3-4b5a-93b6-0c457faa15896

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-1163-010040911630125 VIAL, MULTI-DOSE in 1 TRAY (0409-1163-01) / 50 mL in 1 VIAL, MULTI-DOSE (0409-1163-18) 2005-03-310000-00-00NoNoCurrent
0409-1163-180040911631850 mL in 1 VIAL, MULTI-DOSE50 mlHistorical