Home NDC 51662-1399 BUPIVACAINE HCI AND EPINEPHRINE
Product NDC 51662-1399
11-digit product format 516621399
Labeler code 51662
Product ID 51662-1399_10328ddf-6e3b-c9e0-e063-6294a90a52ed
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name BUPIVACAINE HCI AND EPINEPHRINE
Dosage form INJECTION, SOLUTION
Route PERINEURAL
Labeler HF Acquisition Co LLC, DBA HealthFirst
Application ANDA070968
Marketing category ANDA
Marketing start 2019-12-09
Substance BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
Active strength 5; .005 mg/mL; mg/mL
Pharmacologic classes Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]
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 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 A070968-001 SENSORCAINE BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 0.5%;0.0091MG/ML INJECTABLE / INJECTION AP 1987-10-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A070968-001 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 A070968-001 SENSORCAINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION AP 1987-10-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070968-001 SENSORCAINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION AP 1987-10-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A070968-001 SENSORCAINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION AP 1987-10-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070968-001 SENSORCAINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION AP 1987-10-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070968-001 SENSORCAINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION AP 1987-10-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070968-001 SENSORCAINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION AP 1987-10-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A070968-001 SENSORCAINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION AP 1987-10-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A070968-001 SENSORCAINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION AP 1987-10-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A070968-001 SENSORCAINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION AP 1987-10-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A070968-001 SENSORCAINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION AP 1987-10-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A070968-001 SENSORCAINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION AP 1987-10-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A070968-001 SENSORCAINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION AP 1987-10-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A070968-001 SENSORCAINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION AP 1987-10-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A070968-001 SENSORCAINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION AP 1987-10-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A070968-001 SENSORCAINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION AP 1987-10-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A070968-001 SENSORCAINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION AP 1987-10-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A070968-001 SENSORCAINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION AP 1987-10-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A070968-001 SENSORCAINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION AP 1987-10-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A070968-001 SENSORCAINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION AP 1987-10-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A070968-001 SENSORCAINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION AP 1987-10-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A070968-001 SENSORCAINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION AP 1987-10-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A070968-001 SENSORCAINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION AP 1987-10-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A070968-001 SENSORCAINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION AP 1987-10-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A070968-001 SENSORCAINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION AP 1987-10-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A070968-001 SENSORCAINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION AP 1987-10-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A070968-001 SENSORCAINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION AP 1987-10-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A070968-001 SENSORCAINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION AP 1987-10-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A070968-001 SENSORCAINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION AP 1987-10-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A070968-001 SENSORCAINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION AP 1987-10-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A070968-001 SENSORCAINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION AP 1987-10-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A070968-001 SENSORCAINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION AP 1987-10-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A070968-001 SENSORCAINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION AP 1987-10-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A070968-001 SENSORCAINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION AP 1987-10-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A070968-001 SENSORCAINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION AP 1987-10-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A070968-001 SENSORCAINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION AP 1987-10-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A070968-001 SENSORCAINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION AP 1987-10-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A070968-001 SENSORCAINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION AP 1987-10-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A070968-001 SENSORCAINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION AP 1987-10-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A070968-001 SENSORCAINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION AP 1987-10-13 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A070968-001 SENSORCAINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION AP 1987-10-13 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 HCI AND EPINEPHRINE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BUPIVACAINE HYDROCHLORIDE 5 mg/mL EPINEPHRINE BITARTRATE .005 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7TQO7W3VT8 Internal UNII lookup 30Q7KI53AK Internal UNII 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 51662-1399-1 BUPIVACAINE HCI AND EPINEPHRINE 50 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 50 4 51662-1399-2 BUPIVACAINE HCI AND EPINEPHRINE 50 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 50 4 51662-1399-2 BUPIVACAINE HCI AND EPINEPHRINE 1 in 1 POUCH INJECTION, SOLUTION 1 4 51662-1399-3 BUPIVACAINE HCI AND EPINEPHRINE 25 in 1 CASE INJECTION, SOLUTION 25 4 51662-1399-3 BUPIVACAINE HCI AND EPINEPHRINE 1 in 1 POUCH INJECTION, SOLUTION 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51662-1399 BUPIVACAINE HCI AND EPINEPHRINE INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] 4 Current NDC, Legacy NDC, 5 package rows 20240131_99516811-56e2-9c8a-e053-2a95a90ac9cb.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 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51662-1399-1 51662139901 50 mL in 1 VIAL, MULTI-DOSE (51662-1399-1) 50 ml 2019-12-09 0000-00-00 No No Current 51662-1399-2 51662139902 1 VIAL, MULTI-DOSE in 1 POUCH (51662-1399-2) / 50 mL in 1 VIAL, MULTI-DOSE 2021-01-26 0000-00-00 No No Current 51662-1399-3 51662139903 25 POUCH in 1 CASE (51662-1399-3) / 1 VIAL, MULTI-DOSE in 1 POUCH / 50 mL in 1 VIAL, MULTI-DOSE 25 pouch 2021-01-26 0000-00-00 No No Current