Home NDC 0264-9379 Bupivacaine Hydrochloride with Dextrose
Product NDC 0264-9379
11-digit product format 002649379
Labeler code 0264
Product ID 0264-9379_d74385e7-1d55-4cf8-90f7-f2e6343eb5f4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bupivacaine Hydrochloride with Dextrose
Dosage form INJECTION
Route SUBARACHNOID
Labeler B. Braun Medical Inc.
Application ANDA209087
Marketing category ANDA
Marketing start 2019-04-02
Substance BUPIVACAINE HYDROCHLORIDE
Active strength 7.5 mg/mL
Pharmacologic classes Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A209087-001 BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE 0.75% INJECTABLE / SPINAL AP 2019-04-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A209087-001 AP
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 2 · 42 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 A209087-001 BUPIVACAINE HYDROCHLORIDE 0.75% INJECTABLE / SPINAL AP 2019-04-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209087-001 BUPIVACAINE HYDROCHLORIDE 0.75% INJECTABLE / SPINAL AP 2019-04-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209087-001 BUPIVACAINE HYDROCHLORIDE 0.75% INJECTABLE / SPINAL AP 2019-04-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209087-001 BUPIVACAINE HYDROCHLORIDE 0.75% INJECTABLE / SPINAL AP 2019-04-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209087-001 BUPIVACAINE HYDROCHLORIDE 0.75% INJECTABLE / SPINAL AP 2019-04-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209087-001 BUPIVACAINE HYDROCHLORIDE 0.75% INJECTABLE / SPINAL AP 2019-04-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209087-001 BUPIVACAINE HYDROCHLORIDE 0.75% INJECTABLE / SPINAL AP 2019-04-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209087-001 BUPIVACAINE HYDROCHLORIDE 0.75% INJECTABLE / SPINAL AP 2019-04-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209087-001 BUPIVACAINE HYDROCHLORIDE 0.75% INJECTABLE / SPINAL AP 2019-04-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209087-001 BUPIVACAINE HYDROCHLORIDE 0.75% INJECTABLE / SPINAL AP 2019-04-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209087-001 BUPIVACAINE HYDROCHLORIDE 0.75% INJECTABLE / SPINAL AP 2019-04-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209087-001 BUPIVACAINE HYDROCHLORIDE 0.75% INJECTABLE / SPINAL AP 2019-04-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209087-001 BUPIVACAINE HYDROCHLORIDE 0.75% INJECTABLE / SPINAL AP 2019-04-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209087-001 BUPIVACAINE HYDROCHLORIDE 0.75% INJECTABLE / SPINAL AP 2019-04-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209087-001 BUPIVACAINE HYDROCHLORIDE 0.75% INJECTABLE / SPINAL AP 2019-04-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209087-001 BUPIVACAINE HYDROCHLORIDE 0.75% INJECTABLE / SPINAL AP 2019-04-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209087-001 BUPIVACAINE HYDROCHLORIDE 0.75% INJECTABLE / SPINAL AP 2019-04-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209087-001 BUPIVACAINE HYDROCHLORIDE 0.75% INJECTABLE / SPINAL AP 2019-04-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A209087-001 BUPIVACAINE HYDROCHLORIDE 0.75% INJECTABLE / SPINAL AP 2019-04-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A209087-001 BUPIVACAINE HYDROCHLORIDE 0.75% INJECTABLE / SPINAL AP 2019-04-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209087-001 BUPIVACAINE HYDROCHLORIDE 0.75% INJECTABLE / SPINAL AP 2019-04-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A209087-001 BUPIVACAINE HYDROCHLORIDE 0.75% INJECTABLE / SPINAL AP 2019-04-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A209087-001 BUPIVACAINE HYDROCHLORIDE 0.75% INJECTABLE / SPINAL AP 2019-04-02 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A209087-001 BUPIVACAINE HYDROCHLORIDE 0.75% INJECTABLE / SPINAL AP 2019-04-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A209087-001 BUPIVACAINE HYDROCHLORIDE 0.75% INJECTABLE / SPINAL AP 2019-04-02 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A209087-001 BUPIVACAINE HYDROCHLORIDE 0.75% INJECTABLE / SPINAL AP 2019-04-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A209087-001 BUPIVACAINE HYDROCHLORIDE 0.75% INJECTABLE / SPINAL AP 2019-04-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A209087-001 BUPIVACAINE HYDROCHLORIDE 0.75% INJECTABLE / SPINAL AP 2019-04-02 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209087-001 BUPIVACAINE HYDROCHLORIDE 0.75% INJECTABLE / SPINAL AP 2019-04-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209087-001 BUPIVACAINE HYDROCHLORIDE 0.75% INJECTABLE / SPINAL AP 2019-04-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A209087-001 BUPIVACAINE HYDROCHLORIDE 0.75% INJECTABLE / SPINAL AP 2019-04-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209087-001 BUPIVACAINE HYDROCHLORIDE 0.75% INJECTABLE / SPINAL AP 2019-04-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209087-001 BUPIVACAINE HYDROCHLORIDE 0.75% INJECTABLE / SPINAL AP 2019-04-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209087-001 BUPIVACAINE HYDROCHLORIDE 0.75% INJECTABLE / SPINAL AP 2019-04-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A209087-001 BUPIVACAINE HYDROCHLORIDE 0.75% INJECTABLE / SPINAL AP 2019-04-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A209087-001 BUPIVACAINE HYDROCHLORIDE 0.75% INJECTABLE / SPINAL AP 2019-04-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A209087-001 BUPIVACAINE HYDROCHLORIDE 0.75% INJECTABLE / SPINAL AP 2019-04-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A209087-001 BUPIVACAINE HYDROCHLORIDE 0.75% INJECTABLE / SPINAL AP 2019-04-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A209087-001 BUPIVACAINE HYDROCHLORIDE 0.75% INJECTABLE / SPINAL AP 2019-04-02 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A209087-001 BUPIVACAINE HYDROCHLORIDE 0.75% INJECTABLE / SPINAL AP 2019-04-02 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Bupivacaine Hydrochloride with Dextrose
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BUPIVACAINE HYDROCHLORIDE 7.5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7TQO7W3VT8 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1724784 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0264-9379-88 Bupivacaine Hydrochloride with Dextrose 2 mL in 1 AMPULE INJECTION 2 11 0264-9379-88 Bupivacaine Hydrochloride with Dextrose 10 in 1 CARTON INJECTION 10 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0264-9379 BUPIVACAINE HYDROCHLORIDE WITH DEXTROSE INJECTION [B. BRAUN MEDICAL INC.] 11 Current NDC, Legacy NDC, 2 package rows 20250503_ff43d2b6-acb4-45c8-96b6-971d2a7a6767.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0264-9379-88 00264937988 10 AMPULE in 1 CARTON (0264-9379-88) / 2 mL in 1 AMPULE 10 ampule 2019-04-02 0000-00-00 No No Current