FDA.reportPublic FDA data

Bupivacaine Hydrochloride

Product NDC
59923-720
Requested package NDC
59923-720-10
11-digit product format
599230720
Labeler code
59923
Product ID
59923-720_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
5 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#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage59923-72059923-720-10IInactivated by FDA2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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
59923-720-102023-01-30C16284748780-1f386c649-c80a-0266-e053-dadaa90a7c1aBupivacaine Hydrochloride Injection

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59923-720-10Bupivacaine Hydrochloride10 in 1 CARTONINJECTION102
59923-720-10Bupivacaine Hydrochloride10 mL in 1 AMPULEINJECTION102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59923-720-10ML - Milliliter59923-720356f4f21-4c80-4072-b00e-5e4e7988e94d12019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59923-720BUPIVACAINE 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
59923-720-105992307201010 AMPULE in 1 CARTON (59923-720-10) > 10 mL in 1 AMPULE10 ampule2019-07-120000-00-00NoNoCurrent