FDA.reportPublic FDA data

Bupivacaine Hydrochloride

Product NDC
0143-9329
11-digit product format
001439329
Labeler code
0143
Product ID
0143-9329_df5f611d-cfee-4378-9fc1-154b06ff68af
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupivacaine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
PERINEURAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA205141
Marketing category
ANDA
Marketing start
2021-02-11
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPIVACAINE HYDROCHLORIDE5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7TQO7W3VT8
Rxcui1012396, 1012404

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
0143-9329-01Bupivacaine Hydrochloride50 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION503
0143-9329-10Bupivacaine Hydrochloride10 in 1 CARTONINJECTION, SOLUTION103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9329-01ML - Milliliter0143-93298db04a53-74b3-4060-9c4a-4d57f20e475e12023-01-09
0143-9329-10ML - Milliliter0143-93290aee7876-420b-41be-8f29-37bc91cd93bc12023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9329BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.]3Current NDC, Legacy NDC, 2 package rows20240413_4595c642-1869-436c-9550-8f9f255efd27.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1012396BUPivacaine HCl 0.25 % Injectable SolutionPSN4595c642-1869-436c-9550-8f9f255efd273
1012404BUPivacaine HCl 0.5 % Injectable SolutionPSN4595c642-1869-436c-9550-8f9f255efd273
1012396bupivacaine hydrochloride 2.5 MG/ML Injectable SolutionSCD4595c642-1869-436c-9550-8f9f255efd273
1012404bupivacaine hydrochloride 5 MG/ML Injectable SolutionSCD4595c642-1869-436c-9550-8f9f255efd273
1012396bupivacaine hydrochloride 0.25 % Injectable SolutionSY4595c642-1869-436c-9550-8f9f255efd273
1012404bupivacaine hydrochloride 0.5 % Injectable SolutionSY4595c642-1869-436c-9550-8f9f255efd273

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9329-010014393290150 mL in 1 VIAL, MULTI-DOSE50 mlHistorical
0143-9329-100014393291010 VIAL, MULTI-DOSE in 1 CARTON (0143-9329-10) / 50 mL in 1 VIAL, MULTI-DOSE (0143-9329-01) 2021-02-110000-00-00NoNoCurrent