Bupivacaine Hydrochloride

Product NDC
55154-6970
11-digit product format
551546970
Labeler code
55154
Product ID
55154-6970_b7c59485-ee18-4779-b212-cda5e0b7a331
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUPIVACAINE HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL
Labeler
Cardinal Health 107, LLC
Application
ANDA070583
Marketing category
ANDA
Marketing start
2010-01-06
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
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 HYDROCHLORIDE2.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7TQO7W3VT8
Rxcui1725082

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
55154-6970-5Bupivacaine Hydrochloride30 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION3017
55154-6970-5Bupivacaine Hydrochloride5 in 1 BAGINJECTION, SOLUTION517

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-6970BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [CARDINAL HEALTH 107, LLC]15Current NDC, Legacy NDC, 2 package rows20241018_8f8f4ece-de78-4c13-8d9f-c3bb7053019d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1725082BUPivacaine HCl 0.25 % in 30 ML InjectionPSN8f8f4ece-de78-4c13-8d9f-c3bb7053019d17
172508230 ML bupivacaine hydrochloride 2.5 MG/ML InjectionSCD8f8f4ece-de78-4c13-8d9f-c3bb7053019d17
1725082bupivacaine HCl 0.25 % per 30 ML InjectionSY8f8f4ece-de78-4c13-8d9f-c3bb7053019d17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55154-6970-5551546970055 VIAL, SINGLE-DOSE in 1 BAG (55154-6970-5) / 30 mL in 1 VIAL, SINGLE-DOSE2010-01-060000-00-00NoNoCurrent