FDA.reportPublic FDA data

Bupivacaine Hydrochloride and Epinephrine

Product NDC
0409-9045
Requested package NDC
0409-9045-01
11-digit product format
004099045
Labeler code
0409
Product ID
0409-9045_6e442bfd-d3da-4913-8585-ce3485644364
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL; INTRACAUDAL; PERINEURAL
Labeler
Hospira, Inc.
Application
ANDA071168
Marketing category
ANDA
Marketing start
2005-05-18
Substance
BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
Active strength
5; 5 mg/mL; ug/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
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A071168-001BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINEBUPIVACAINE HYDROCHLORIDE; EPINEPHRINE0.5%;0.005MG/MLINJECTABLE / INJECTIONAPRS1988-06-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A071168-001AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A071168-001BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE0.5%;0.005MG/MLINJECTABLE / INJECTIONAPRS1988-06-16a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A071168-001AP1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEHospira, Inc.02a845c3-4521-4926-e397-25ab536e7cf62026-03-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071168
application number: ANDA071168
ndc (package): 0409-9045-01
ndc (product): 0409-9045
ndc11 (package): 00409904501

Additional Listing Data#

Finished product
Yes
Brand name base
Bupivacaine Hydrochloride and Epinephrine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPIVACAINE HYDROCHLORIDE5 mg/mL
EPINEPHRINE BITARTRATE5 ug/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
30Q7KI53AKInternal UNII lookup
7TQO7W3VT8Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 14 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1012377Internal RxNorm lookup
1012384Internal RxNorm lookup
1012396Internal RxNorm lookup
1012404Internal RxNorm lookup
1672917Internal RxNorm lookup
1672919Internal RxNorm lookup
1724786Internal RxNorm lookup
1724787Internal RxNorm lookup
1724880Internal RxNorm lookup
1724884Internal RxNorm lookup
1725078Internal RxNorm lookup
1725082Internal RxNorm lookup
1867594Internal RxNorm lookup
1867596Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
02a845c3-4521-4926-e397-25ab536e7cf6Available on FDA.report

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
0409-9045-01Bupivacaine Hydrochloride and Epinephrine10 in 1 CARTONINJECTION, SOLUTION1039
0409-9045-11Bupivacaine Hydrochloride and Epinephrine10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION1039
0409-9045-16Bupivacaine Hydrochloride and Epinephrine30 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION3039
0409-9045-17Bupivacaine Hydrochloride and Epinephrine25 in 1 TRAYINJECTION, SOLUTION2539

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-9045-01ML - Milliliter0409-904532ea8575-cbda-4c3a-bf74-76b0e7789e7e12012-07-24
0409-9045-02ML - Milliliter0409-9045c6822569-5777-4abc-a11c-462f661ca67412012-07-24
0409-9045-11ML - Milliliter0409-904595f0c3ed-9ced-4a4d-aef2-e556f71396ad12017-07-07
0409-9045-16ML - Milliliter0409-904515d17c15-2c63-4351-ad49-97859992318712017-05-03
0409-9045-17ML - Milliliter0409-9045bf725caa-7c57-4e8f-849a-dac1bf09114612012-07-24

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
0409-9045BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION [HOSPIRA, INC.]38Current NDC, Legacy NDC, 4 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0409-9045-010040990450110 VIAL, SINGLE-DOSE in 1 CARTON (0409-9045-01) / 10 mL in 1 VIAL, SINGLE-DOSE (0409-9045-11) 2005-09-080000-00-00NoNoCurrent