Home NDC 76420-008 Bupivacaine Hydrochloride
Product NDC 76420-008
11-digit product format 764200008
Labeler code 76420
Product ID 76420-008_ead08199-44c1-c795-e053-2995a90a7e08
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bupivacaine Hydrochloride
Dosage form INJECTION, SOLUTION
Route EPIDURAL; INTRACAUDAL
Labeler Asclemed USA, Inc.
Application ANDA203895
Marketing category ANDA
Marketing start 2013-11-05
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 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 1 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 2026-09-14 22:38:34 2026-08 A203895-001 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.25% INJECTABLE / INJECTION AP 2013-11-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203895-002 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.5% INJECTABLE / INJECTION AP 2013-11-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203895-003 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.75% INJECTABLE / INJECTION AP 2013-11-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 A203895-001 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.25% INJECTABLE / INJECTION AP 2013-11-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203895-002 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.5% INJECTABLE / INJECTION AP 2013-11-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203895-003 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.75% INJECTABLE / INJECTION AP 2013-11-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203895-001 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.25% INJECTABLE / INJECTION AP 2013-11-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203895-002 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.5% INJECTABLE / INJECTION AP 2013-11-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203895-003 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.75% INJECTABLE / INJECTION AP 2013-11-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203895-001 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.25% INJECTABLE / INJECTION AP 2013-11-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203895-002 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.5% INJECTABLE / INJECTION AP 2013-11-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203895-003 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.75% INJECTABLE / INJECTION AP 2013-11-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203895-001 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.25% INJECTABLE / INJECTION AP 2013-11-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203895-002 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.5% INJECTABLE / INJECTION AP 2013-11-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203895-003 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.75% INJECTABLE / INJECTION AP 2013-11-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203895-001 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.25% INJECTABLE / INJECTION AP 2013-11-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203895-002 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.5% INJECTABLE / INJECTION AP 2013-11-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203895-003 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.75% INJECTABLE / INJECTION AP 2013-11-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203895-001 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.25% INJECTABLE / INJECTION AP 2013-11-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203895-002 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.5% INJECTABLE / INJECTION AP 2013-11-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203895-003 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.75% INJECTABLE / INJECTION AP 2013-11-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203895-001 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.25% INJECTABLE / INJECTION AP 2013-11-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203895-002 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.5% INJECTABLE / INJECTION AP 2013-11-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203895-003 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.75% INJECTABLE / INJECTION AP 2013-11-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203895-001 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.25% INJECTABLE / INJECTION AP 2013-11-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203895-002 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.5% INJECTABLE / INJECTION AP 2013-11-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203895-003 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.75% INJECTABLE / INJECTION AP 2013-11-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203895-001 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.25% INJECTABLE / INJECTION AP 2013-11-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203895-002 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.5% INJECTABLE / INJECTION AP 2013-11-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203895-003 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.75% INJECTABLE / INJECTION AP 2013-11-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203895-001 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.25% INJECTABLE / INJECTION AP 2013-11-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203895-002 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.5% INJECTABLE / INJECTION AP 2013-11-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203895-003 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.75% INJECTABLE / INJECTION AP 2013-11-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203895-001 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.25% INJECTABLE / INJECTION AP 2013-11-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203895-002 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.5% INJECTABLE / INJECTION AP 2013-11-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203895-003 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.75% INJECTABLE / INJECTION AP 2013-11-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203895-001 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.25% INJECTABLE / INJECTION AP 2013-11-05 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203895-002 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.5% INJECTABLE / INJECTION AP 2013-11-05 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203895-003 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.75% INJECTABLE / INJECTION AP 2013-11-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203895-001 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.25% INJECTABLE / INJECTION AP 2013-11-05 301d65b070ca…
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 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 76420-008-10 Bupivacaine Hydrochloride 10 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 10 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76420-008 BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [ASCLEMED USA, INC.] 2 Current NDC, Legacy NDC, 1 package rows 20221013_a60303c2-5217-41db-855b-83fa2a749da2.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 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 ndc (product): 76420-008 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 Units Marketing start Marketing end Sample Exclude flag Status 76420-008-10 76420000810 10 mL in 1 VIAL, SINGLE-DOSE (76420-008-10) 10 ml 2020-01-16 0000-00-00 No No Current