SENSORCAINE(R) (BUPIVACAINE HCI AND EPINEPHRINE)

Product NDC
51662-1397
11-digit product format
516621397
Labeler code
51662
Product ID
51662-1397_1032a94b-35f3-8839-e063-6394a90a5f7b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SENSORCAINE(R) (BUPIVACAINE HCI AND EPINEPHRINE)
Dosage form
INJECTION, SOLUTION
Route
INFILTRATION; PERINEURAL
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
ANDA070967
Marketing category
ANDA
Marketing start
2019-10-08
Substance
BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
Active strength
2.5; .005 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

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
A070967-001SENSORCAINEBUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE0.25%;0.0091MG/MLINJECTABLE / INJECTIONAP1987-10-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A070967-001AP

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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A070967-001SENSORCAINE0.25%;0.0091MG/MLINJECTABLE / INJECTIONAP1987-10-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070967-001SENSORCAINE0.25%;0.0091MG/MLINJECTABLE / INJECTIONAP1987-10-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A070967-001SENSORCAINE0.25%;0.0091MG/MLINJECTABLE / INJECTIONAP1987-10-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070967-001SENSORCAINE0.25%;0.0091MG/MLINJECTABLE / INJECTIONAP1987-10-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070967-001SENSORCAINE0.25%;0.0091MG/MLINJECTABLE / INJECTIONAP1987-10-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070967-001SENSORCAINE0.25%;0.0091MG/MLINJECTABLE / INJECTIONAP1987-10-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070967-001SENSORCAINE0.25%;0.0091MG/MLINJECTABLE / INJECTIONAP1987-10-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070967-001SENSORCAINE0.25%;0.0091MG/MLINJECTABLE / INJECTIONAP1987-10-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070967-001SENSORCAINE0.25%;0.0091MG/MLINJECTABLE / INJECTIONAP1987-10-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A070967-001SENSORCAINE0.25%;0.0091MG/MLINJECTABLE / INJECTIONAP1987-10-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070967-001SENSORCAINE0.25%;0.0091MG/MLINJECTABLE / INJECTIONAP1987-10-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070967-001SENSORCAINE0.25%;0.0091MG/MLINJECTABLE / INJECTIONAP1987-10-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070967-001SENSORCAINE0.25%;0.0091MG/MLINJECTABLE / INJECTIONAP1987-10-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A070967-001SENSORCAINE0.25%;0.0091MG/MLINJECTABLE / INJECTIONAP1987-10-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A070967-001SENSORCAINE0.25%;0.0091MG/MLINJECTABLE / INJECTIONAP1987-10-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A070967-001SENSORCAINE0.25%;0.0091MG/MLINJECTABLE / INJECTIONAP1987-10-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A070967-001SENSORCAINE0.25%;0.0091MG/MLINJECTABLE / INJECTIONAP1987-10-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A070967-001SENSORCAINE0.25%;0.0091MG/MLINJECTABLE / INJECTIONAP1987-10-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A070967-001SENSORCAINE0.25%;0.0091MG/MLINJECTABLE / INJECTIONAP1987-10-13bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A070967-001SENSORCAINE0.25%;0.0091MG/MLINJECTABLE / INJECTIONAP1987-10-13782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A070967-001SENSORCAINE0.25%;0.0091MG/MLINJECTABLE / INJECTIONAP1987-10-1387673890dc5c…
2021-03-12 10:30 UTC2021-03A070967-001SENSORCAINE0.25%;0.0091MG/MLINJECTABLE / INJECTIONAP1987-10-135aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A070967-001SENSORCAINE0.25%;0.0091MG/MLINJECTABLE / INJECTIONAP1987-10-138869cabd3fbd…
2020-11-12 02:37 UTC2020-11A070967-001SENSORCAINE0.25%;0.0091MG/MLINJECTABLE / INJECTIONAP1987-10-13c0c555d07b60…
2019-12-14 00:12 UTC2019-12A070967-001SENSORCAINE0.25%;0.0091MG/MLINJECTABLE / INJECTIONAP1987-10-133f01610625f2…
2019-09-15 20:21 UTC2019-09A070967-001SENSORCAINE0.25%;0.0091MG/MLINJECTABLE / INJECTIONAP1987-10-13b00525d2431f…
2019-07-19 19:46 UTC2019-07A070967-001SENSORCAINE0.25%;0.0091MG/MLINJECTABLE / INJECTIONAP1987-10-13ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A070967-001SENSORCAINE0.25%;0.0091MG/MLINJECTABLE / INJECTIONAP1987-10-136a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A070967-001SENSORCAINE0.25%;0.0091MG/MLINJECTABLE / INJECTIONAP1987-10-131c564ffb4f44…
2023-12-20 04:57 UTC2023-12A070967-001SENSORCAINE0.25%;0.0091MG/MLINJECTABLE / INJECTIONAP1987-10-13ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A070967-001SENSORCAINE0.25%;0.0091MG/MLINJECTABLE / INJECTIONAP1987-10-13a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A070967-001SENSORCAINE0.25%;0.0091MG/MLINJECTABLE / INJECTIONAP1987-10-139b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A070967-001SENSORCAINE0.25%;0.0091MG/MLINJECTABLE / INJECTIONAP1987-10-13a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A070967-001SENSORCAINE0.25%;0.0091MG/MLINJECTABLE / INJECTIONAP1987-10-133f0d92c62455…
2023-05-13 08:27 UTC2023-05A070967-001SENSORCAINE0.25%;0.0091MG/MLINJECTABLE / INJECTIONAP1987-10-13053a50430f4f…
2023-01-26 05:58 UTC2023-01A070967-001SENSORCAINE0.25%;0.0091MG/MLINJECTABLE / INJECTIONAP1987-10-133bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A070967-001SENSORCAINE0.25%;0.0091MG/MLINJECTABLE / INJECTIONAP1987-10-133a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A070967-001SENSORCAINE0.25%;0.0091MG/MLINJECTABLE / INJECTIONAP1987-10-13f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A070967-001SENSORCAINE0.25%;0.0091MG/MLINJECTABLE / INJECTIONAP1987-10-13e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A070967-001SENSORCAINE0.25%;0.0091MG/MLINJECTABLE / INJECTIONAP1987-10-13cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A070967-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070967-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A070967-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070967-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070967-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070967-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070967-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070967-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070967-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A070967-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070967-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070967-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070967-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A070967-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A070967-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A070967-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A070967-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A070967-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A070967-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A070967-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A070967-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A070967-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A070967-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A070967-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A070967-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A070967-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A070967-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A070967-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A070967-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A070967-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A070967-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A070967-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A070967-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A070967-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A070967-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A070967-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A070967-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A070967-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A070967-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A070967-001AP1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
SENSORCAINE(R) (BUPIVACAINE HCI AND EPINEPHRINE)
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPIVACAINE HYDROCHLORIDE2.5 mg/mL
EPINEPHRINE BITARTRATE.005 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1012377Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
946ce625-3647-5083-e053-2a95a90a1ebcAvailable 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
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
2686d634-e712-4007-8dbf-3d37c6c4d71fProduct name120181121
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
bd49bb86-2d32-4a7a-a594-eeda2e29af42Product name120180118
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
3becbe78-12d9-4ad2-9b4c-1e36f8d1303aProduct name120170815

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51662-1397-1SENSORCAINE(R) (BUPIVACAINE HCI AND EPINEPHRINE)50 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION504
51662-1397-2SENSORCAINE(R) (BUPIVACAINE HCI AND EPINEPHRINE)50 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION504
51662-1397-2SENSORCAINE(R) (BUPIVACAINE HCI AND EPINEPHRINE)1 in 1 POUCHINJECTION, SOLUTION14
51662-1397-3SENSORCAINE(R) (BUPIVACAINE HCI AND EPINEPHRINE)1 in 1 POUCHINJECTION, SOLUTION14
51662-1397-3SENSORCAINE(R) (BUPIVACAINE HCI AND EPINEPHRINE)25 in 1 CASEINJECTION, SOLUTION254

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1397SENSORCAINE(R) (BUPIVACAINE HCI AND EPINEPHRINE) INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]4Current NDC, Legacy NDC, 5 package rows20240131_946ce625-3647-5083-e053-2a95a90a1ebc.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SENSORCAINE(R) (BUPIVACAINE HCI AND EPINEPHRINE)SENSORCAINE(R) (BUPIVACAINE HCI AND EPINEPHRINE)HF Acquisition Co LLC, DBA HealthFirst946ce625-3647-5083-e053-2a95a90a1ebc2024-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070967
application number: ANDA070967
ndc (product): 51662-1397
SENSORCAINEBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEFresenius Kabi USA, LLCbc61a9a6-0a4e-48a9-b908-e5e66b9f23eb2023-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070967
application number: ANDA070967

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1012377BUPivacaine HCl 0.25 % / EPINEPHrine 1:200,000 Injectable SolutionPSN946ce625-3647-5083-e053-2a95a90a1ebc4
1012377bupivacaine hydrochloride 2.5 MG/ML / epinephrine 0.005 MG/ML Injectable SolutionSCD946ce625-3647-5083-e053-2a95a90a1ebc4
1012377bupivacaine hydrochloride 0.25 % / epinephrine (as epinephrine bitartrate) 1:200,000 Injectable SolutionSY946ce625-3647-5083-e053-2a95a90a1ebc4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1397-15166213970150 mL in 1 VIAL, MULTI-DOSE (51662-1397-1) 50 ml2019-10-080000-00-00NoNoCurrent
51662-1397-2516621397021 VIAL, MULTI-DOSE in 1 POUCH (51662-1397-2) / 50 mL in 1 VIAL, MULTI-DOSE2021-01-260000-00-00NoNoCurrent
51662-1397-35166213970325 POUCH in 1 CASE (51662-1397-3) / 1 VIAL, MULTI-DOSE in 1 POUCH / 50 mL in 1 VIAL, MULTI-DOSE25 pouch2021-01-260000-00-00NoNoCurrent