Burapren 0.75%

Product NDC
70529-008
Requested package NDC
70529-008-01
11-digit product format
705290008
Labeler code
70529
Product ID
70529-008_02e9115c-06fc-4afc-ba57-da8b891e0e76
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupivacaine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL; RETROBULBAR
Labeler
IT3 Medical LLC
Application
ANDA203895
Marketing category
ANDA
Marketing start
2017-03-01
Marketing end
0000-00-00
Substance
BUPIVACAINE HYDROCHLORIDE
Active strength
8 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#

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 packagepackage70529-00870529-008-01IInactivated by FDA2026-09-09

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…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203895-001BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREEBUPIVACAINE HYDROCHLORIDE0.25%INJECTABLE / INJECTIONAP2013-11-05
A203895-002BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREEBUPIVACAINE HYDROCHLORIDE0.5%INJECTABLE / INJECTIONAP2013-11-05
A203895-003BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREEBUPIVACAINE HYDROCHLORIDE0.75%INJECTABLE / INJECTIONAP2013-11-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A203895-001AP
A203895-002AP
A203895-003AP

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.

Product history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A203895-001BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.25%INJECTABLE / INJECTIONAP2013-11-05caaa826d4ba7…
2026-08-18 06:07:402026-07A203895-002BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.5%INJECTABLE / INJECTIONAP2013-11-05caaa826d4ba7…
2026-08-18 06:07:402026-07A203895-003BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.75%INJECTABLE / INJECTIONAP2013-11-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203895-001BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.25%INJECTABLE / INJECTIONAP2013-11-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203895-002BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.5%INJECTABLE / INJECTIONAP2013-11-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203895-003BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.75%INJECTABLE / INJECTIONAP2013-11-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203895-001BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.25%INJECTABLE / INJECTIONAP2013-11-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203895-002BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.5%INJECTABLE / INJECTIONAP2013-11-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203895-003BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.75%INJECTABLE / INJECTIONAP2013-11-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A203895-001BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.25%INJECTABLE / INJECTIONAP2013-11-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203895-002BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.5%INJECTABLE / INJECTIONAP2013-11-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203895-003BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.75%INJECTABLE / INJECTIONAP2013-11-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203895-001BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.25%INJECTABLE / INJECTIONAP2013-11-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203895-002BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.5%INJECTABLE / INJECTIONAP2013-11-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203895-003BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.75%INJECTABLE / INJECTIONAP2013-11-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203895-001BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.25%INJECTABLE / INJECTIONAP2013-11-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203895-002BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.5%INJECTABLE / INJECTIONAP2013-11-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203895-003BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.75%INJECTABLE / INJECTIONAP2013-11-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203895-001BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.25%INJECTABLE / INJECTIONAP2013-11-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203895-002BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.5%INJECTABLE / INJECTIONAP2013-11-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203895-003BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.75%INJECTABLE / INJECTIONAP2013-11-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203895-001BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.25%INJECTABLE / INJECTIONAP2013-11-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203895-002BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.5%INJECTABLE / INJECTIONAP2013-11-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203895-003BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.75%INJECTABLE / INJECTIONAP2013-11-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203895-001BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.25%INJECTABLE / INJECTIONAP2013-11-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203895-002BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.5%INJECTABLE / INJECTIONAP2013-11-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203895-003BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.75%INJECTABLE / INJECTIONAP2013-11-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203895-001BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.25%INJECTABLE / INJECTIONAP2013-11-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203895-002BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.5%INJECTABLE / INJECTIONAP2013-11-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203895-003BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.75%INJECTABLE / INJECTIONAP2013-11-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203895-001BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.25%INJECTABLE / INJECTIONAP2013-11-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A203895-002BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.5%INJECTABLE / INJECTIONAP2013-11-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A203895-003BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.75%INJECTABLE / INJECTIONAP2013-11-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203895-001BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.25%INJECTABLE / INJECTIONAP2013-11-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203895-002BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.5%INJECTABLE / INJECTIONAP2013-11-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203895-003BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.75%INJECTABLE / INJECTIONAP2013-11-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203895-001BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.25%INJECTABLE / INJECTIONAP2013-11-05301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203895-002BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.5%INJECTABLE / INJECTIONAP2013-11-05301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203895-003BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.75%INJECTABLE / INJECTIONAP2013-11-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203895-001BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.25%INJECTABLE / INJECTIONAP2013-11-051e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A203895-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A203895-002AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A203895-003AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203895-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203895-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203895-003AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203895-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203895-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203895-003AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203895-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203895-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203895-003AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203895-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203895-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203895-003AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203895-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203895-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203895-003AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203895-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203895-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203895-003AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203895-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203895-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203895-003AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203895-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203895-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203895-003AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203895-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203895-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203895-003AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203895-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203895-002AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203895-003AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203895-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203895-002AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203895-003AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203895-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203895-002AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203895-003AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203895-001AP11e350fbaab3a…

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70529-008-01Burapren 0.75%30 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION304
70529-008-01Burapren 0.75%1 in 1 PACKAGEINJECTION, SOLUTION14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70529-008BURAPREN 0.75% (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [IT3 MEDICAL LLC]4Legacy NDC, 2 package rows20220302_85667365-c166-4fd4-a8dc-d0d3340179fc.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 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): 203895
application number: ANDA203895
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEAsclemed USA, Inc.a60303c2-5217-41db-855b-83fa2a749da22022-10-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203895
application number: ANDA203895
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEAsclemed USA, Inc.3eefbefe-78ae-4f2d-9be6-3f79eadcff862020-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203895
application number: ANDA203895

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1724786BUPivacaine HCl 0.75 % in 30 ML InjectionPSN85667365-c166-4fd4-a8dc-d0d3340179fc4
172478630 ML bupivacaine hydrochloride 7.5 MG/ML InjectionSCD85667365-c166-4fd4-a8dc-d0d3340179fc4
1724786bupivacaine HCl 0.75 % in 30 ML InjectionSY85667365-c166-4fd4-a8dc-d0d3340179fc4
1724786bupivacaine HCl 225 MG per 30 ML InjectionSY85667365-c166-4fd4-a8dc-d0d3340179fc4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70529-008-01705290008011 VIAL, SINGLE-DOSE in 1 PACKAGE (70529-008-01) > 30 mL in 1 VIAL, SINGLE-DOSE2017-03-010000-00-00NoNoCurrent