Home NDC 85766-013 Bupivacaine Hydrochloride
Product NDC 85766-013
11-digit product format 857660013
Labeler code 85766
Product ID 85766-013_49eeda32-7627-4c62-e063-6394a90af3eb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name BUPIVACAINE HYDROCHLORIDE
Dosage form INJECTION, SOLUTION
Route EPIDURAL; INTRACAUDAL; PERINEURAL
Labeler Sportpharm LLC
Application ANDA070584
Marketing category ANDA
Marketing start 2005-11-22
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A070584-001 BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1986-02-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A070584-001 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 · 41 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 2026-02-19 14:30 UTC 2026-02 A070584-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1986-02-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070584-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1986-02-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A070584-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1986-02-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070584-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1986-02-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070584-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1986-02-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070584-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1986-02-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A070584-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1986-02-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A070584-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1986-02-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A070584-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1986-02-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A070584-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1986-02-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A070584-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1986-02-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A070584-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1986-02-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A070584-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1986-02-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A070584-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1986-02-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A070584-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1986-02-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A070584-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1986-02-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A070584-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1986-02-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A070584-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1986-02-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A070584-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1986-02-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A070584-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1986-02-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A070584-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1986-02-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A070584-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1986-02-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A070584-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1986-02-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A070584-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1986-02-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A070584-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1986-02-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A070584-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1986-02-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A070584-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1986-02-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A070584-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1986-02-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A070584-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1986-02-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A070584-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1986-02-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A070584-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1986-02-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A070584-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1986-02-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A070584-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1986-02-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A070584-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1986-02-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A070584-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1986-02-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A070584-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1986-02-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A070584-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1986-02-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A070584-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1986-02-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A070584-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1986-02-17 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A070584-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1986-02-17 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Bupivacaine Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BUPIVACAINE HYDROCHLORIDE 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 1724880 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 85766-013-10 Bupivacaine Hydrochloride 10 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 10 4
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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Bupivacaine Hydrochloride BUPIVACAINE HYDROCHLORIDE Hospira, Inc. 02a845c3-4521-4926-e397-25ab536e7cf6 2026-03-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 070584 application number: ANDA070584 Bupivacaine Hydrochloride BUPIVACAINE HYDROCHLORIDE Sportpharm LLC 0e6a55f0-5107-4ea9-9ee1-5c6c09bbe4a6 2026-02-03 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 070584 application number: ANDA070584 ndc (product): 85766-013 Bupivacaine Hydrochloride BUPIVACAINE HYDROCHLORIDE ProPharma Distribution 42c973e2-307b-924c-e063-6394a90a737a 2025-12-18 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 070584 application number: ANDA070584 Bupivacaine Hydrochloride BUPIVACAINE HYDROCHLORIDE Asclemed USA, Inc. 8759cac8-d977-4c2a-814c-5b59f2f0c910 2023-08-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 070584 application number: ANDA070584
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85766-013-10 85766001310 10 mL in 1 VIAL, SINGLE-DOSE (85766-013-10) 10 ml 2025-06-20 No No Current