FDA.reportPublic FDA data

Bupivacaine Hydrochloride

Product NDC
59923-717
11-digit product format
599230717
Labeler code
59923
Product ID
59923-717_b8e455c5-46b7-1827-e053-2a95a90ae2d7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupivacaine Hydrochloride
Dosage form
INJECTION
Route
EPIDURAL; INTRACAUDAL; PERINEURAL
Labeler
Areva Pharmaceuticals
Marketing category
UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE
Marketing start
2019-07-12
Marketing end
0000-00-00
Substance
BUPIVACAINE HYDROCHLORIDE ANHYDROUS
Active strength
3 mg/mL
Pharmacologic classes
Amide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct59923-717IInactivated by FDA2026-07-31
excluded packagepackage59923-71759923-717-05IInactivated by FDA2026-07-31

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59923-717-052023-01-30C16284748780-1f386c649-c80a-0266-e053-dadaa90a7c1aBupivacaine Hydrochloride Injection

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59923-717-05Bupivacaine Hydrochloride5 mL in 1 AMPULEINJECTION52
59923-717-05Bupivacaine Hydrochloride10 in 1 CARTONINJECTION102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59923-717-05ML - Milliliter59923-7176d0c17c3-ace0-4d4f-a7f8-eca6422959f212019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59923-717BUPIVACAINE HYDROCHLORIDE INJECTION [AREVA PHARMACEUTICALS]2Legacy NDC, 2 package rows20210115_8c168503-9120-20ea-e053-2a95a90a8bf2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1725078BUPivacaine HCl 0.25 % in 10 ML InjectionPSN8c168503-9120-20ea-e053-2a95a90a8bf22
2178759BUPivacaine HCl 0.25 % in 5 ML InjectionPSN8c168503-9120-20ea-e053-2a95a90a8bf22
1724880BUPivacaine HCl 0.5 % in 10 ML InjectionPSN8c168503-9120-20ea-e053-2a95a90a8bf22
2178760BUPivacaine HCl 0.5 % in 5 ML InjectionPSN8c168503-9120-20ea-e053-2a95a90a8bf22
172507810 ML bupivacaine hydrochloride 2.5 MG/ML InjectionSCD8c168503-9120-20ea-e053-2a95a90a8bf22
172488010 ML bupivacaine hydrochloride 5 MG/ML InjectionSCD8c168503-9120-20ea-e053-2a95a90a8bf22
21787595 ML bupivacaine hydrochloride 2.5 MG/ML InjectionSCD8c168503-9120-20ea-e053-2a95a90a8bf22
21787605 ML bupivacaine hydrochloride 5 MG/ML InjectionSCD8c168503-9120-20ea-e053-2a95a90a8bf22
1725078bupivacaine HCl 0.25 % in 10 ML InjectionSY8c168503-9120-20ea-e053-2a95a90a8bf22
2178759bupivacaine HCl 0.25 % in 5 ML InjectionSY8c168503-9120-20ea-e053-2a95a90a8bf22
1724880bupivacaine HCl 0.5 % in 10 ML InjectionSY8c168503-9120-20ea-e053-2a95a90a8bf22
2178760bupivacaine HCl 0.5 % in 5 ML InjectionSY8c168503-9120-20ea-e053-2a95a90a8bf22
2178759bupivacaine HCl 12.5 MG per 5 ML InjectionSY8c168503-9120-20ea-e053-2a95a90a8bf22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59923-717-055992307170510 AMPULE in 1 CARTON (59923-717-05) > 5 mL in 1 AMPULE10 ampule2019-07-120000-00-00NoNoCurrent