Home NDC 0404-9946 Sensorcaine MPF
Product NDC 0404-9946
11-digit product format 004049946
Labeler code 0404
Product ID 0404-9946_054a57b2-376c-43ff-af2c-17a073362e29
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name bupivacaine hydrochloride
Dosage form INJECTION, SOLUTION
Route EPIDURAL; INTRACAUDAL; PERINEURAL
Labeler Henry Schein, Inc.
Application ANDA070553
Marketing category ANDA
Marketing start 2022-01-12
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 A070553-001 SENSORCAINE BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1986-05-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A070553-001 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 A070553-001 SENSORCAINE 0.5% INJECTABLE / INJECTION AP 1986-05-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A070553-001 SENSORCAINE 0.5% INJECTABLE / INJECTION AP 1986-05-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070553-001 SENSORCAINE 0.5% INJECTABLE / INJECTION AP 1986-05-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A070553-001 SENSORCAINE 0.5% INJECTABLE / INJECTION AP 1986-05-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070553-001 SENSORCAINE 0.5% INJECTABLE / INJECTION AP 1986-05-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070553-001 SENSORCAINE 0.5% INJECTABLE / INJECTION AP 1986-05-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070553-001 SENSORCAINE 0.5% INJECTABLE / INJECTION AP 1986-05-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A070553-001 SENSORCAINE 0.5% INJECTABLE / INJECTION AP 1986-05-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A070553-001 SENSORCAINE 0.5% INJECTABLE / INJECTION AP 1986-05-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A070553-001 SENSORCAINE 0.5% INJECTABLE / INJECTION AP 1986-05-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A070553-001 SENSORCAINE 0.5% INJECTABLE / INJECTION AP 1986-05-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A070553-001 SENSORCAINE 0.5% INJECTABLE / INJECTION AP 1986-05-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A070553-001 SENSORCAINE 0.5% INJECTABLE / INJECTION AP 1986-05-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A070553-001 SENSORCAINE 0.5% INJECTABLE / INJECTION AP 1986-05-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A070553-001 SENSORCAINE 0.5% INJECTABLE / INJECTION AP 1986-05-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A070553-001 SENSORCAINE 0.5% INJECTABLE / INJECTION AP 1986-05-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A070553-001 SENSORCAINE 0.5% INJECTABLE / INJECTION AP 1986-05-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A070553-001 SENSORCAINE 0.5% INJECTABLE / INJECTION AP 1986-05-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A070553-001 SENSORCAINE 0.5% INJECTABLE / INJECTION AP 1986-05-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A070553-001 SENSORCAINE 0.5% INJECTABLE / INJECTION AP 1986-05-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A070553-001 SENSORCAINE 0.5% INJECTABLE / INJECTION AP 1986-05-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A070553-001 SENSORCAINE 0.5% INJECTABLE / INJECTION AP 1986-05-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A070553-001 SENSORCAINE 0.5% INJECTABLE / INJECTION AP 1986-05-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A070553-001 SENSORCAINE 0.5% INJECTABLE / INJECTION AP 1986-05-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A070553-001 SENSORCAINE 0.5% INJECTABLE / INJECTION AP 1986-05-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A070553-001 SENSORCAINE 0.5% INJECTABLE / INJECTION AP 1986-05-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A070553-001 SENSORCAINE 0.5% INJECTABLE / INJECTION AP 1986-05-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A070553-001 SENSORCAINE 0.5% INJECTABLE / INJECTION AP 1986-05-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A070553-001 SENSORCAINE 0.5% INJECTABLE / INJECTION AP 1986-05-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A070553-001 SENSORCAINE 0.5% INJECTABLE / INJECTION AP 1986-05-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A070553-001 SENSORCAINE 0.5% INJECTABLE / INJECTION AP 1986-05-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A070553-001 SENSORCAINE 0.5% INJECTABLE / INJECTION AP 1986-05-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A070553-001 SENSORCAINE 0.5% INJECTABLE / INJECTION AP 1986-05-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A070553-001 SENSORCAINE 0.5% INJECTABLE / INJECTION AP 1986-05-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A070553-001 SENSORCAINE 0.5% INJECTABLE / INJECTION AP 1986-05-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A070553-001 SENSORCAINE 0.5% INJECTABLE / INJECTION AP 1986-05-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A070553-001 SENSORCAINE 0.5% INJECTABLE / INJECTION AP 1986-05-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A070553-001 SENSORCAINE 0.5% INJECTABLE / INJECTION AP 1986-05-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A070553-001 SENSORCAINE 0.5% INJECTABLE / INJECTION AP 1986-05-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A070553-001 SENSORCAINE 0.5% INJECTABLE / INJECTION AP 1986-05-21 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 Sensorcaine MPF
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 1724880 Internal RxNorm lookup 1724881 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 0404-9946-10 Sensorcaine MPF 10 mL in 1 VIAL INJECTION, SOLUTION 10 6 0404-9946-10 Sensorcaine MPF 1 in 1 BAG INJECTION, SOLUTION 1 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0404-9946 SENSORCAINE MPF (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [HENRY SCHEIN, INC.] 5 Current NDC, Legacy NDC, 2 package rows 20240507_78c6789d-773e-4b26-90bd-34a6b6d730ce.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 Sensorcaine MPF BUPIVACAINE HYDROCHLORIDE Henry Schein, Inc. 78c6789d-773e-4b26-90bd-34a6b6d730ce 2025-11-07 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 070553 application number: ANDA070553 ndc (product): 0404-9946 SENSORCAINE MPF BUPIVACAINE HYDROCHLORIDE Fresenius Kabi USA, LLC b6bfc04a-1868-4630-9ca1-8c027af97ce3 2024-11-18 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 070553 application number: ANDA070553 Sensorcaine MPF BUPIVACAINE HYDROCHLORIDE Fresenius Kabi USA, LLC e700eb7b-8b14-49c9-96b2-331f18776e45 2023-05-12 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 070553 application number: ANDA070553
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 0404-9946-10 00404994610 1 VIAL in 1 BAG (0404-9946-10) / 10 mL in 1 VIAL 1 vial 2022-01-12 0000-00-00 No No Current