Home NDC 72603-279-25 bupivacaine hydrochloride
Product NDC 72603-279
Requested package NDC 72603-279-25
11-digit product format 726030279
Labeler code 72603
Product ID 72603-279_4439cf55-3d69-4363-984f-dee716b14472
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name bupivacaine hydrochloride
Dosage form INJECTION, SOLUTION
Route INFILTRATION; PERINEURAL
Labeler Northstar Rx LLC
Application ANDA216039
Marketing category ANDA
Marketing start 2024-12-16
Marketing end 2026-11-17
Substance BUPIVACAINE HYDROCHLORIDE
Active strength 2.5 mg/mL
Pharmacologic classes Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]
NDC exclude flag No
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A216039-001 BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION 2023-06-23 A216039-002 BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION 2023-06-23
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 · 46 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 A216039-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION 2023-06-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 A216039-002 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION 2023-06-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 A216039-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION 2023-06-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216039-002 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION 2023-06-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216039-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 2023-06-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216039-002 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 2023-06-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216039-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 2023-06-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216039-002 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 2023-06-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216039-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 2023-06-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216039-002 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 2023-06-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216039-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 2023-06-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216039-002 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 2023-06-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216039-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 2023-06-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216039-002 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 2023-06-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216039-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 2023-06-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216039-002 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 2023-06-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216039-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 2023-06-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216039-002 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 2023-06-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216039-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 2023-06-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216039-002 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 2023-06-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216039-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 2023-06-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216039-002 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 2023-06-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216039-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 2023-06-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A216039-002 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 2023-06-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216039-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 2023-06-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216039-002 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 2023-06-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216039-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 2023-06-23 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216039-002 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 2023-06-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216039-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 2023-06-23 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216039-002 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 2023-06-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216039-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 2023-06-23 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A216039-002 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 2023-06-23 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216039-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 2023-06-23 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216039-002 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 2023-06-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216039-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 2023-06-23 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A216039-002 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 2023-06-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216039-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 2023-06-23 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A216039-002 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 2023-06-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216039-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 2023-06-23 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216039-002 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 2023-06-23 a72a2bbeb626…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 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 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 72603-279-01 bupivacaine hydrochloride 50 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 50 2 72603-279-25 bupivacaine hydrochloride 25 in 1 CARTON INJECTION, SOLUTION 25 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72603-279 BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [NORTHSTAR RX LLC] 1 Current NDC, 2 package rows 20241217_adadc041-8d5e-4bf8-a89b-e227729a880d.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.
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 72603-279-25 72603027925 25 VIAL, MULTI-DOSE in 1 CARTON (72603-279-25) / 50 mL in 1 VIAL, MULTI-DOSE (72603-279-01) 2024-12-16 2026-11-17 No No Historical