Home NDC 70529-008-01 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 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 date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A203895-001 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 2013-11-05 A203895-002 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 2013-11-05 A203895-003 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE BUPIVACAINE HYDROCHLORIDE 0.75% INJECTABLE / INJECTION AP 2013-11-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A203895-001 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.25% INJECTABLE / INJECTION AP 2013-11-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203895-002 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.5% INJECTABLE / INJECTION AP 2013-11-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203895-003 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.75% INJECTABLE / INJECTION AP 2013-11-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203895-001 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.25% INJECTABLE / INJECTION AP 2013-11-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203895-002 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.5% INJECTABLE / INJECTION AP 2013-11-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203895-003 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.75% INJECTABLE / INJECTION AP 2013-11-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203895-001 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.25% INJECTABLE / INJECTION AP 2013-11-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203895-002 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.5% INJECTABLE / INJECTION AP 2013-11-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203895-003 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.75% INJECTABLE / INJECTION AP 2013-11-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203895-001 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.25% INJECTABLE / INJECTION AP 2013-11-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203895-002 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.5% INJECTABLE / INJECTION AP 2013-11-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203895-003 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.75% INJECTABLE / INJECTION AP 2013-11-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203895-001 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.25% INJECTABLE / INJECTION AP 2013-11-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203895-002 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.5% INJECTABLE / INJECTION AP 2013-11-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203895-003 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.75% INJECTABLE / INJECTION AP 2013-11-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203895-001 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.25% INJECTABLE / INJECTION AP 2013-11-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203895-002 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.5% INJECTABLE / INJECTION AP 2013-11-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203895-003 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.75% INJECTABLE / INJECTION AP 2013-11-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203895-001 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.25% INJECTABLE / INJECTION AP 2013-11-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203895-002 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.5% INJECTABLE / INJECTION AP 2013-11-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203895-003 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.75% INJECTABLE / INJECTION AP 2013-11-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203895-001 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.25% INJECTABLE / INJECTION AP 2013-11-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203895-002 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.5% INJECTABLE / INJECTION AP 2013-11-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203895-003 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.75% INJECTABLE / INJECTION AP 2013-11-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203895-001 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.25% INJECTABLE / INJECTION AP 2013-11-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203895-002 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.5% INJECTABLE / INJECTION AP 2013-11-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203895-003 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.75% INJECTABLE / INJECTION AP 2013-11-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203895-001 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.25% INJECTABLE / INJECTION AP 2013-11-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203895-002 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.5% INJECTABLE / INJECTION AP 2013-11-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203895-003 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.75% INJECTABLE / INJECTION AP 2013-11-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203895-001 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.25% INJECTABLE / INJECTION AP 2013-11-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203895-002 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.5% INJECTABLE / INJECTION AP 2013-11-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203895-003 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.75% INJECTABLE / INJECTION AP 2013-11-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203895-001 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.25% INJECTABLE / INJECTION AP 2013-11-05 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203895-002 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.5% INJECTABLE / INJECTION AP 2013-11-05 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203895-003 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.75% INJECTABLE / INJECTION AP 2013-11-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203895-001 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.25% INJECTABLE / INJECTION AP 2013-11-05 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203895-002 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.5% INJECTABLE / INJECTION AP 2013-11-05 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203895-003 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.75% INJECTABLE / INJECTION AP 2013-11-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203895-001 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.25% INJECTABLE / INJECTION AP 2013-11-05 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70529-008-01 Burapren 0.75% 30 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 30 4 70529-008-01 Burapren 0.75% 1 in 1 PACKAGE INJECTION, SOLUTION 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70529-008 BURAPREN 0.75% (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [IT3 MEDICAL LLC] 4 Legacy NDC, 2 package rows 20220302_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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Bupivacaine Hydrochloride BUPIVACAINE HYDROCHLORIDE Eugia US LLC ffecf450-1f01-4721-8e10-251385852612 2025-05-29 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 203895 application number: ANDA203895 Bupivacaine Hydrochloride BUPIVACAINE HYDROCHLORIDE Asclemed USA, Inc. a60303c2-5217-41db-855b-83fa2a749da2 2022-10-12 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 203895 application number: ANDA203895 Bupivacaine Hydrochloride BUPIVACAINE HYDROCHLORIDE Asclemed USA, Inc. 3eefbefe-78ae-4f2d-9be6-3f79eadcff86 2020-04-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 203895 application number: ANDA203895
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 70529-008-01 70529000801 1 VIAL, SINGLE-DOSE in 1 PACKAGE (70529-008-01) > 30 mL in 1 VIAL, SINGLE-DOSE 2017-03-01 0000-00-00 No No Current