Home NDC 0143-9328 Bupivacaine Hydrochloride
Product NDC 0143-9328
11-digit product format 001439328
Labeler code 0143
Product ID 0143-9328_df5f611d-cfee-4378-9fc1-154b06ff68af
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bupivacaine Hydrochloride
Dosage form INJECTION, SOLUTION
Route INFILTRATION; PERINEURAL
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA205141
Marketing category ANDA
Marketing start 2021-02-11
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 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A205141-001 BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 2021-02-11 A205141-002 BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 2021-02-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 2 · 68 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 A205141-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 2021-02-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205141-002 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 2021-02-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205141-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 2021-02-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205141-002 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 2021-02-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205141-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 2021-02-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205141-002 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 2021-02-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205141-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 2021-02-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205141-002 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 2021-02-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205141-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 2021-02-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205141-002 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 2021-02-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205141-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 2021-02-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205141-002 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 2021-02-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205141-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 2021-02-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205141-002 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 2021-02-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205141-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 2021-02-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205141-002 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 2021-02-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205141-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 2021-02-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205141-002 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 2021-02-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205141-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 2021-02-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A205141-002 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 2021-02-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205141-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 2021-02-11 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205141-002 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 2021-02-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205141-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 2021-02-11 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205141-002 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 2021-02-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205141-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 2021-02-11 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205141-002 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 2021-02-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205141-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 2021-02-11 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A205141-002 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 2021-02-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205141-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 2021-02-11 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205141-002 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 2021-02-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205141-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 2021-02-11 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A205141-002 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 2021-02-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205141-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 2021-02-11 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A205141-002 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 2021-02-11 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A205141-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 2021-02-11 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A205141-002 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 2021-02-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A205141-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 2021-02-11 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A205141-002 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 2021-02-11 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A205141-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 2021-02-11 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A205141-002 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 2021-02-11 87673890dc5c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 68 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 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 · 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 0143-9328-01 Bupivacaine Hydrochloride 50 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 50 3 0143-9328-10 Bupivacaine Hydrochloride 10 in 1 CARTON INJECTION, SOLUTION 10 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0143-9328 BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.] 3 Current NDC, Legacy NDC, 2 package rows 20240413_4595c642-1869-436c-9550-8f9f255efd27.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 · 1 matching rows.
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 0143-9328-01 00143932801 50 mL in 1 VIAL, MULTI-DOSE 50 ml Historical 0143-9328-10 00143932810 10 VIAL, MULTI-DOSE in 1 CARTON (0143-9328-10) / 50 mL in 1 VIAL, MULTI-DOSE (0143-9328-01) 2021-02-11 0000-00-00 No No Current