FDA.reportPublic FDA data

bupivacaine hydrochloride

Product NDC
72603-287
11-digit product format
726030287
Labeler code
72603
Product ID
72603-287_4439cf55-3d69-4363-984f-dee716b14472
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupivacaine hydrochloride
Dosage form
INJECTION, SOLUTION
Route
PERINEURAL
Labeler
Northstar Rx LLC
Application
ANDA216039
Marketing category
ANDA
Marketing start
2024-12-16
Marketing end
2026-11-17
Substance
BUPIVACAINE HYDROCHLORIDE
Active strength
5 mg/mL
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
bupivacaine hydrochloride

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
72603-287-01bupivacaine hydrochloride50 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION502
72603-287-25bupivacaine hydrochloride25 in 1 CARTONINJECTION, SOLUTION252

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-287-01ML - Milliliter72603-287c7f9dfc6-02c2-4305-b916-4a3ea67fe92912025-03-04
72603-287-25ML - Milliliter72603-28730232cd5-3826-4fd3-a915-c86d1f32b25d12025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-287BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [NORTHSTAR RX LLC]1Current NDC, 2 package rows20241217_adadc041-8d5e-4bf8-a89b-e227729a880d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1012396BUPivacaine HCl 0.25 % Injectable SolutionPSNadadc041-8d5e-4bf8-a89b-e227729a880d2
1012404BUPivacaine HCl 0.5 % Injectable SolutionPSNadadc041-8d5e-4bf8-a89b-e227729a880d2
1012396bupivacaine hydrochloride 2.5 MG/ML Injectable SolutionSCDadadc041-8d5e-4bf8-a89b-e227729a880d2
1012404bupivacaine hydrochloride 5 MG/ML Injectable SolutionSCDadadc041-8d5e-4bf8-a89b-e227729a880d2
1012396bupivacaine hydrochloride 0.25 % Injectable SolutionSYadadc041-8d5e-4bf8-a89b-e227729a880d2
1012404bupivacaine hydrochloride 0.5 % Injectable SolutionSYadadc041-8d5e-4bf8-a89b-e227729a880d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72603-287-017260302870150 mL in 1 VIAL, MULTI-DOSE50 mlHistorical
72603-287-257260302872525 VIAL, MULTI-DOSE in 1 CARTON (72603-287-25) / 50 mL in 1 VIAL, MULTI-DOSE (72603-287-01) 2024-12-162026-11-17NoNoHistorical