Home NDC 51662-1396 BUPIVACAINE HYDROCHLORIDE
Product NDC 51662-1396
11-digit product format 516621396
Labeler code 51662
Product ID 51662-1396_1b5824c7-c46a-48c6-e063-6394a90a22ce
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name BUPIVACAINE HYDROCHLORIDE
Dosage form INJECTION, SOLUTION
Route PERINEURAL
Labeler HF Acquisition Co LLC, DBA HealthFirst
Application ANDA070597
Marketing category ANDA
Marketing start 2019-10-16
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 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 A070597-001 BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1987-03-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A070597-001 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 A070597-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1987-03-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A070597-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1987-03-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070597-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1987-03-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A070597-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1987-03-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070597-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1987-03-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070597-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1987-03-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070597-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1987-03-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A070597-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1987-03-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A070597-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1987-03-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A070597-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1987-03-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A070597-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1987-03-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A070597-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1987-03-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A070597-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1987-03-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A070597-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1987-03-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A070597-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1987-03-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A070597-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1987-03-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A070597-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1987-03-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A070597-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1987-03-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A070597-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1987-03-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A070597-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1987-03-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A070597-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1987-03-03 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A070597-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1987-03-03 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A070597-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1987-03-03 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A070597-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1987-03-03 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A070597-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1987-03-03 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A070597-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1987-03-03 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A070597-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1987-03-03 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A070597-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1987-03-03 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A070597-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1987-03-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A070597-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1987-03-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A070597-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1987-03-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A070597-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1987-03-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A070597-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1987-03-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A070597-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1987-03-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A070597-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1987-03-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A070597-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1987-03-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A070597-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1987-03-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A070597-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1987-03-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A070597-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1987-03-03 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A070597-001 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1987-03-03 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
Listing expiration 2026-12-31 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1012396 Internal RxNorm lookup 1012404 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 51662-1396-1 BUPIVACAINE HYDROCHLORIDE 50 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 50 11 51662-1396-2 BUPIVACAINE HYDROCHLORIDE 1 mL in 1 POUCH INJECTION, SOLUTION 1 11 51662-1396-3 BUPIVACAINE HYDROCHLORIDE 25 in 1 CASE INJECTION, SOLUTION 25 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51662-1396 BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION 0.25% BUPIVACAINE HCL INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] 11 Current NDC, Legacy NDC, 3 package rows 20240622_950d82b6-76a1-0c08-e053-2a95a90a3a92.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 Hospira, Inc. 02a845c3-4521-4926-e397-25ab536e7cf6 2026-03-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 070597 application number: ANDA070597 Bupivacaine Hydrochloride BUPIVACAINE HYDROCHLORIDE Henry Schein, Inc 496ccd9e-d1c3-4b5a-93b6-0c457faa1589 2025-10-27 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 070597 application number: ANDA070597 BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE HF Acquisition Co LLC, DBA HealthFirst 950d82b6-76a1-0c08-e053-2a95a90a3a92 2024-06-20 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 070597 application number: ANDA070597 ndc (product): 51662-1396
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 51662-1396-1 51662139601 50 mL in 1 VIAL, MULTI-DOSE (51662-1396-1) 50 ml 2019-10-16 0000-00-00 No No Current 51662-1396-2 51662139602 1 mL in 1 POUCH 1 ml Historical 51662-1396-3 51662139603 25 POUCH in 1 CASE (51662-1396-3) / 1 mL in 1 POUCH (51662-1396-2) 25 pouch 2020-10-27 0000-00-00 No No Current