Sensorcaine

Product NDC
0404-9947
11-digit product format
004049947
Labeler code
0404
Product ID
0404-9947_6f90cc96-c462-455f-a92b-47ac6722d062
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupivacaine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
PERINEURAL
Labeler
Henry Schein, Inc.
Application
NDA018304
Marketing category
NDA
Marketing start
2022-01-12
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
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N018304-001SENSORCAINEBUPIVACAINE HYDROCHLORIDE0.25%INJECTABLE / INJECTIONAPRLD, Approved before 1982
N018304-002SENSORCAINEBUPIVACAINE HYDROCHLORIDE0.5%INJECTABLE / INJECTIONAPRLD, Approved before 1982
N018304-003SENSORCAINEBUPIVACAINE HYDROCHLORIDE0.75%INJECTABLE / INJECTIONAPRLD, Approved before 1982
N018304-004SENSORCAINEBUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE0.5%;0.0091MG/MLINJECTABLE / INJECTIONAPRLD1983-09-02
N018304-005SENSORCAINEBUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE0.75%;0.0091MG/MLINJECTABLE / INJECTIONAPRLD1983-09-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-productTE code
N018304-001AP
N018304-002AP
N018304-003AP
N018304-004AP
N018304-005AP

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.

Product history page 1 of 6 · 210 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N018304-001SENSORCAINE0.25%INJECTABLE / INJECTIONAPRLD, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N018304-002SENSORCAINE0.5%INJECTABLE / INJECTIONAPRLD, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N018304-003SENSORCAINE0.75%INJECTABLE / INJECTIONAPRLD, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N018304-004SENSORCAINE0.5%;0.0091MG/MLINJECTABLE / INJECTIONAPRLD1983-09-02caaa826d4ba7…
2026-08-18 06:07:402026-07N018304-005SENSORCAINE0.75%;0.0091MG/MLINJECTABLE / INJECTIONAPRLD1983-09-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018304-001SENSORCAINE0.25%INJECTABLE / INJECTIONAPRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018304-002SENSORCAINE0.5%INJECTABLE / INJECTIONAPRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018304-003SENSORCAINE0.75%INJECTABLE / INJECTIONAPRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018304-004SENSORCAINE0.5%;0.0091MG/MLINJECTABLE / INJECTIONAPRLD1983-09-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018304-005SENSORCAINE0.75%;0.0091MG/MLINJECTABLE / INJECTIONAPRLD1983-09-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018304-001SENSORCAINE0.25%INJECTABLE / INJECTIONAPRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018304-002SENSORCAINE0.5%INJECTABLE / INJECTIONAPRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018304-003SENSORCAINE0.75%INJECTABLE / INJECTIONAPRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018304-004SENSORCAINE0.5%;0.0091MG/MLINJECTABLE / INJECTIONAPRLD1983-09-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018304-005SENSORCAINE0.75%;0.0091MG/MLINJECTABLE / INJECTIONAPRLD1983-09-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08N018304-001SENSORCAINE0.25%INJECTABLE / INJECTIONAPRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018304-002SENSORCAINE0.5%INJECTABLE / INJECTIONAPRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018304-003SENSORCAINE0.75%INJECTABLE / INJECTIONAPRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018304-004SENSORCAINE0.5%;0.0091MG/MLINJECTABLE / INJECTIONAPRLD1983-09-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018304-005SENSORCAINE0.75%;0.0091MG/MLINJECTABLE / INJECTIONAPRLD1983-09-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018304-001SENSORCAINE0.25%INJECTABLE / INJECTIONAPRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018304-002SENSORCAINE0.5%INJECTABLE / INJECTIONAPRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018304-003SENSORCAINE0.75%INJECTABLE / INJECTIONAPRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018304-004SENSORCAINE0.5%;0.0091MG/MLINJECTABLE / INJECTIONAPRLD1983-09-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018304-005SENSORCAINE0.75%;0.0091MG/MLINJECTABLE / INJECTIONAPRLD1983-09-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018304-001SENSORCAINE0.25%INJECTABLE / INJECTIONAPRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018304-002SENSORCAINE0.5%INJECTABLE / INJECTIONAPRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018304-003SENSORCAINE0.75%INJECTABLE / INJECTIONAPRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018304-004SENSORCAINE0.5%;0.0091MG/MLINJECTABLE / INJECTIONAPRLD1983-09-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018304-005SENSORCAINE0.75%;0.0091MG/MLINJECTABLE / INJECTIONAPRLD1983-09-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018304-001SENSORCAINE0.25%INJECTABLE / INJECTIONAPRLD, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018304-002SENSORCAINE0.5%INJECTABLE / INJECTIONAPRLD, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018304-003SENSORCAINE0.75%INJECTABLE / INJECTIONAPRLD, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018304-004SENSORCAINE0.5%;0.0091MG/MLINJECTABLE / INJECTIONAPRLD1983-09-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018304-005SENSORCAINE0.75%;0.0091MG/MLINJECTABLE / INJECTIONAPRLD1983-09-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018304-001SENSORCAINE0.25%INJECTABLE / INJECTIONAPRLD, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018304-002SENSORCAINE0.5%INJECTABLE / INJECTIONAPRLD, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018304-003SENSORCAINE0.75%INJECTABLE / INJECTIONAPRLD, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018304-004SENSORCAINE0.5%;0.0091MG/MLINJECTABLE / INJECTIONAPRLD1983-09-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018304-005SENSORCAINE0.75%;0.0091MG/MLINJECTABLE / INJECTIONAPRLD1983-09-022680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 210 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N018304-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07N018304-002AP1caaa826d4ba7…
2026-08-18 06:07:402026-07N018304-003AP1caaa826d4ba7…
2026-08-18 06:07:402026-07N018304-004AP1caaa826d4ba7…
2026-08-18 06:07:402026-07N018304-005AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018304-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018304-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018304-003AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018304-004AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018304-005AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018304-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018304-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018304-003AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018304-004AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018304-005AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N018304-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018304-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018304-003AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018304-004AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018304-005AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018304-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018304-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018304-003AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018304-004AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018304-005AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018304-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018304-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018304-003AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018304-004AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018304-005AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018304-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018304-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018304-003AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018304-004AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018304-005AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018304-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018304-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018304-003AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018304-004AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018304-005AP12680178bc6a6…

Additional Listing Data#

Finished product
Yes
Brand name base
Sensorcaine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPIVACAINE HYDROCHLORIDE5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1012404Internal RxNorm lookup
1012457Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
100201ad-6e4d-4e91-8b5c-621d0bf0dcc2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cbf85893-59ef-423f-87d4-a573c000a8b9Product name820250731
5dad6767-dcd1-b0da-8727-7f3f7bc3a435Product name220250303
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
e3a99641-4540-4894-9108-00cab3c57b7eProduct name120211207
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
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
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
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
0404-9947-50Sensorcaine1 in 1 BAGINJECTION, SOLUTION15
0404-9947-50Sensorcaine50 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION505

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0404-9947SENSORCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [HENRY SCHEIN, INC.]4Current NDC, Legacy NDC, 2 package rows20241016_100201ad-6e4d-4e91-8b5c-621d0bf0dcc2.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BUPIVACAINE HClBUPIVACAINE HCLHF Acquisition Co LLC, DBA HealthFirste391f807-7699-6d82-e053-2a95a90ab6412026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 018304
application number: NDA018304
SensorcaineBUPIVACAINE HYDROCHLORIDEHenry Schein, Inc.2046d833-2974-42fd-a29e-7fc1dc7166cc2025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 018304
application number: NDA018304
SensorcaineBUPIVACAINE HYDROCHLORIDEHenry Schein, Inc.100201ad-6e4d-4e91-8b5c-621d0bf0dcc22025-11-07Warnings, Adverse reactionsExact identifier
application applno (NDA): 018304
application number: NDA018304
ndc (product): 0404-9947
SENSORCAINE MPFBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEFresenius Kabi USA, LLCeb6d8fee-def4-4c96-9972-695e8cea8ea82024-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 018304
application number: NDA018304
SENSORCAINE MPFBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEFresenius Kabi USA, LLCdcf3c0ad-9eb8-4ee7-96df-d0db7ff231752022-08-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 018304
application number: NDA018304

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1012404BUPivacaine HCl 0.5 % Injectable SolutionPSN100201ad-6e4d-4e91-8b5c-621d0bf0dcc25
1012457Sensorcaine 0.5 % Injectable SolutionPSN100201ad-6e4d-4e91-8b5c-621d0bf0dcc25
1012457bupivacaine hydrochloride 5 MG/ML Injectable Solution [Sensorcaine]SBD100201ad-6e4d-4e91-8b5c-621d0bf0dcc25
1012404bupivacaine hydrochloride 5 MG/ML Injectable SolutionSCD100201ad-6e4d-4e91-8b5c-621d0bf0dcc25
1012404bupivacaine hydrochloride 0.5 % Injectable SolutionSY100201ad-6e4d-4e91-8b5c-621d0bf0dcc25
1012457Sensorcaine 0.5 % Injectable SolutionSY100201ad-6e4d-4e91-8b5c-621d0bf0dcc25
1012457Sensorcaine 5 MG/ML Injectable SolutionSY100201ad-6e4d-4e91-8b5c-621d0bf0dcc25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0404-9947-50004049947501 VIAL, MULTI-DOSE in 1 BAG (0404-9947-50) / 50 mL in 1 VIAL, MULTI-DOSE2022-01-120000-00-00NoNoCurrent