FDA.reportPublic FDA data

Burapren 0.5%

Product NDC
70529-006
Requested package NDC
70529-006-01
11-digit product format
705290006
Labeler code
70529
Product ID
70529-006_d1438201-4f2c-4f15-922c-3b00e3536f2c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupivacaine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
PERINEURAL
Labeler
IT3 Medical LLC
Application
ANDA207183
Marketing category
ANDA
Marketing start
2017-03-01
Marketing end
0000-00-00
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
2023-12-31
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. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70529-00670529-006-01IInactivated by FDA2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207183-001BUPIVACAINE HYDROCHLORIDEBUPIVACAINE HYDROCHLORIDE0.25%INJECTABLE / INJECTIONAP2016-05-13
A207183-002BUPIVACAINE HYDROCHLORIDEBUPIVACAINE HYDROCHLORIDE0.5%INJECTABLE / INJECTIONAP2016-05-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A207183-001AP
A207183-002AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A207183-001BUPIVACAINE HYDROCHLORIDE0.25%INJECTABLE / INJECTIONAP2016-05-13a50c72e98297…
2026-08-01 22:54:322026-06A207183-002BUPIVACAINE HYDROCHLORIDE0.5%INJECTABLE / INJECTIONAP2016-05-13a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A207183-001AP1a50c72e98297…
2026-08-01 22:54:322026-06A207183-002AP1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEEugia US LLCffecf450-1f01-4721-8e10-2513858526122025-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207183
application number: ANDA207183
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEA-S Medication Solutions1091d4d8-5dad-46e1-8f26-7bc0c5dd833f2024-05-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207183
application number: ANDA207183
BUPIVACAINE HCIBUPIVACAINE HCIHF Acquisition Co LLC, DBA HealthFirste37e1599-db88-2fcd-e053-2995a90a00e52024-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207183
application number: ANDA207183
BUPIVACAINE HYDROCHLORIDE injection, solutionBUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTIONHF Acquisition Co LLC, DBA HealthFirst06c15208-c600-7173-e063-6394a90a2f942024-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207183
application number: ANDA207183
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEMedical Purchasing Solutions, LLC694926ac-aff0-aa1f-e053-2991aa0a95882023-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207183
application number: ANDA207183
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEMedical Purchasing Solutions, LLCd1642239-4230-b679-e053-2a95a90a3b7c2023-05-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207183
application number: ANDA207183

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
70529-006-012023-07-28C16284748780-1d6a99b39-3704-a426-e053-dadaa90af4c2Burapren 0.5% Injection System
70529-006-012022-03-01C16284748780-1d6a99b39-3704-a426-e053-dadaa90af4c2Burapren 0.5% Injection System
70529-006-012022-01-28C16284748780-1d6a99b39-3704-a426-e053-dadaa90af4c2Burapren 0.5% Injection System

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70529-006-01Burapren 0.5%1 in 1 PACKAGEINJECTION, SOLUTION14
70529-006-01Burapren 0.5%50 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70529-006BURAPREN 0.5% (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [IT3 MEDICAL LLC]4Legacy NDC, 2 package rows20220302_464690ce-cc70-4bbb-8769-69b710908be1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1012404BUPivacaine HCl 0.5 % Injectable SolutionPSN464690ce-cc70-4bbb-8769-69b710908be14
1012404bupivacaine hydrochloride 5 MG/ML Injectable SolutionSCD464690ce-cc70-4bbb-8769-69b710908be14
1012404bupivacaine hydrochloride 0.5 % Injectable SolutionSY464690ce-cc70-4bbb-8769-69b710908be14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70529-006-01705290006011 VIAL, MULTI-DOSE in 1 PACKAGE (70529-006-01) > 50 mL in 1 VIAL, MULTI-DOSE2017-03-010000-00-00NoNoCurrent