Home NDC 55150-167 Bupivacaine Hydrochloride
Product NDC 55150-167
11-digit product format 551500167
Labeler code 55150
Product ID 55150-167_39649703-e633-4a20-ba71-0c04dbf8ff2a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bupivacaine Hydrochloride
Dosage form INJECTION, SOLUTION
Route EPIDURAL; INFILTRATION; INTRACAUDAL
Labeler Eugia US LLC
Application ANDA203895
Marketing category ANDA
Marketing start 2013-11-05
Substance BUPIVACAINE HYDROCHLORIDE
Active strength 2.5 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 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A203895-001 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 2013-11-05 A203895-002 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 2013-11-05 A203895-003 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE BUPIVACAINE HYDROCHLORIDE 0.75% INJECTABLE / INJECTION AP 2013-11-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 2 of 4 · 129 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 2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203895-002 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.5% INJECTABLE / INJECTION AP 2013-11-05 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203895-003 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.75% INJECTABLE / INJECTION AP 2013-11-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203895-001 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.25% INJECTABLE / INJECTION AP 2013-11-05 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203895-002 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.5% INJECTABLE / INJECTION AP 2013-11-05 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203895-003 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.75% INJECTABLE / INJECTION AP 2013-11-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203895-001 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.25% INJECTABLE / INJECTION AP 2013-11-05 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A203895-002 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.5% INJECTABLE / INJECTION AP 2013-11-05 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A203895-003 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.75% INJECTABLE / INJECTION AP 2013-11-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203895-001 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.25% INJECTABLE / INJECTION AP 2013-11-05 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203895-002 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.5% INJECTABLE / INJECTION AP 2013-11-05 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203895-003 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.75% INJECTABLE / INJECTION AP 2013-11-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203895-001 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.25% INJECTABLE / INJECTION AP 2013-11-05 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A203895-002 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.5% INJECTABLE / INJECTION AP 2013-11-05 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A203895-003 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.75% INJECTABLE / INJECTION AP 2013-11-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203895-001 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.25% INJECTABLE / INJECTION AP 2013-11-05 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A203895-002 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.5% INJECTABLE / INJECTION AP 2013-11-05 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A203895-003 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.75% INJECTABLE / INJECTION AP 2013-11-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203895-001 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.25% INJECTABLE / INJECTION AP 2013-11-05 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A203895-002 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.5% INJECTABLE / INJECTION AP 2013-11-05 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A203895-003 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.75% INJECTABLE / INJECTION AP 2013-11-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203895-001 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.25% INJECTABLE / INJECTION AP 2013-11-05 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A203895-002 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.5% INJECTABLE / INJECTION AP 2013-11-05 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A203895-003 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.75% INJECTABLE / INJECTION AP 2013-11-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203895-001 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.25% INJECTABLE / INJECTION AP 2013-11-05 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A203895-002 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.5% INJECTABLE / INJECTION AP 2013-11-05 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A203895-003 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.75% INJECTABLE / INJECTION AP 2013-11-05 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203895-001 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.25% INJECTABLE / INJECTION AP 2013-11-05 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203895-002 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.5% INJECTABLE / INJECTION AP 2013-11-05 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203895-003 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.75% INJECTABLE / INJECTION AP 2013-11-05 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A203895-001 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.25% INJECTABLE / INJECTION AP 2013-11-05 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 A203895-002 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.5% INJECTABLE / INJECTION AP 2013-11-05 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 A203895-003 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.75% INJECTABLE / INJECTION AP 2013-11-05 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A203895-001 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.25% INJECTABLE / INJECTION AP 2013-11-05 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 A203895-002 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.5% INJECTABLE / INJECTION AP 2013-11-05 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 A203895-003 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.75% INJECTABLE / INJECTION AP 2013-11-05 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A203895-001 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.25% INJECTABLE / INJECTION AP 2013-11-05 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 A203895-002 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.5% INJECTABLE / INJECTION AP 2013-11-05 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 A203895-003 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.75% INJECTABLE / INJECTION AP 2013-11-05 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A203895-001 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.25% INJECTABLE / INJECTION AP 2013-11-05 3f01610625f2…2019-12-14 00:12 UTC 2019-12 A203895-002 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.5% INJECTABLE / INJECTION AP 2013-11-05 3f01610625f2…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 2.5 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 · 8 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1012396 Internal RxNorm lookup 1012404 Internal RxNorm lookup 1724786 Internal RxNorm lookup 1724787 Internal RxNorm lookup 1724880 Internal RxNorm lookup 1724884 Internal RxNorm lookup 1725078 Internal RxNorm lookup 1725082 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 55150-167-10 Bupivacaine Hydrochloride 10 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 10 9 55150-167-10 Bupivacaine Hydrochloride 25 in 1 CARTON INJECTION, SOLUTION 25 9
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55150-167 BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [EUGIA US LLC] 9 Current NDC, Legacy NDC, 2 package rows 20250516_ffecf450-1f01-4721-8e10-251385852612.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 Eugia US LLC ffecf450-1f01-4721-8e10-251385852612 2025-05-29 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 203895 application number: ANDA203895 ndc (product): 55150-167 Bupivacaine Hydrochloride BUPIVACAINE HYDROCHLORIDE Asclemed USA, Inc. a60303c2-5217-41db-855b-83fa2a749da2 2022-10-12 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 203895 application number: ANDA203895 Bupivacaine Hydrochloride BUPIVACAINE HYDROCHLORIDE Asclemed USA, Inc. 3eefbefe-78ae-4f2d-9be6-3f79eadcff86 2020-04-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 203895 application number: ANDA203895
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 55150-167-10 55150016710 25 VIAL, SINGLE-DOSE in 1 CARTON (55150-167-10) / 10 mL in 1 VIAL, SINGLE-DOSE 2013-11-05 0000-00-00 No No Current