FDA.reportPublic FDA data

Sensorcaine

Product NDC
0404-9945
11-digit product format
004049945
Labeler code
0404
Product ID
0404-9945_1a2d83ee-c3bc-4957-81a4-c3f020bd81f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupivacaine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INFILTRATION; PERINEURAL
Labeler
Henry Schein, Inc.
Application
NDA018304
Marketing category
NDA
Marketing start
2022-01-12
Substance
BUPIVACAINE HYDROCHLORIDE
Active strength
2.5 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
Sensorcaine
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7TQO7W3VT8
Rxcui1012396, 1012455

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cbf85893-59ef-423f-87d4-a573c000a8b9Product name820250731
5dad6767-dcd1-b0da-8727-7f3f7bc3a435Product name220250303
e3a99641-4540-4894-9108-00cab3c57b7eProduct name120211207
5da98533-f072-406b-9e1b-6ac19eca9926Product name120210622
306b993e-3140-4823-ad5e-88b708f9d2acProduct name120210510
a831e694-3663-4a83-82be-6c309429f750Product name220200608

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0404-9945-50Sensorcaine1 in 1 BAGINJECTION, SOLUTION16
0404-9945-50Sensorcaine50 mL in 1 VIALINJECTION, SOLUTION506

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0404-9945SENSORCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [HENRY SCHEIN, INC.]4Current NDC, Legacy NDC, 2 package rows20240808_2046d833-2974-42fd-a29e-7fc1dc7166cc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1012396BUPivacaine HCl 0.25 % Injectable SolutionPSN2046d833-2974-42fd-a29e-7fc1dc7166cc6
1012455Sensorcaine 0.25 % Injectable SolutionPSN2046d833-2974-42fd-a29e-7fc1dc7166cc6
1012455bupivacaine hydrochloride 2.5 MG/ML Injectable Solution [Sensorcaine]SBD2046d833-2974-42fd-a29e-7fc1dc7166cc6
1012396bupivacaine hydrochloride 2.5 MG/ML Injectable SolutionSCD2046d833-2974-42fd-a29e-7fc1dc7166cc6
1012396bupivacaine hydrochloride 0.25 % Injectable SolutionSY2046d833-2974-42fd-a29e-7fc1dc7166cc6
1012455Sensorcaine 0.25 % Injectable SolutionSY2046d833-2974-42fd-a29e-7fc1dc7166cc6
1012455Sensorcaine 2.5 MG/ML Injectable SolutionSY2046d833-2974-42fd-a29e-7fc1dc7166cc6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0404-9945-50004049945501 VIAL in 1 BAG (0404-9945-50) / 50 mL in 1 VIAL1 vial2022-01-120000-00-00NoNoCurrent