Home NDC 70594-115-01 BUPIVACAINE HCl
Product NDC 70594-115
Requested package NDC 70594-115-01
11-digit product format 705940115
Labeler code 70594
Product ID 70594-115_afc179ac-71b9-4021-8b71-3372bf590e4a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bupivacaine hydrochloride
Dosage form INJECTION, SOLUTION
Route EPIDURAL; INTRACAUDAL; PERINEURAL
Labeler Xellia Pharmaceuticals USA LLC
Application ANDA091487
Marketing category ANDA
Marketing start 2023-06-01
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 44 .
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 A091487-001 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 2011-10-18 A091487-002 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 2011-10-18 A091487-003 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE BUPIVACAINE HYDROCHLORIDE 0.75% INJECTABLE / INJECTION AP 2011-10-18
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 · 132 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 2026-10-15 13:18:30 2026-09 A091487-001 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.5% INJECTABLE / INJECTION AP 2011-10-18 c2088c7a36db…2026-10-15 13:18:30 2026-09 A091487-002 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.25% INJECTABLE / INJECTION AP 2011-10-18 c2088c7a36db…2026-10-15 13:18:30 2026-09 A091487-003 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.75% INJECTABLE / INJECTION AP 2011-10-18 c2088c7a36db…2026-09-14 22:38:34 2026-08 A091487-001 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.5% INJECTABLE / INJECTION AP 2011-10-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 A091487-002 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.25% INJECTABLE / INJECTION AP 2011-10-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 A091487-003 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.75% INJECTABLE / INJECTION AP 2011-10-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 A091487-001 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.5% INJECTABLE / INJECTION AP 2011-10-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091487-002 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.25% INJECTABLE / INJECTION AP 2011-10-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091487-003 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.75% INJECTABLE / INJECTION AP 2011-10-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091487-001 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.5% INJECTABLE / INJECTION AP 2011-10-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091487-002 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.25% INJECTABLE / INJECTION AP 2011-10-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091487-003 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.75% INJECTABLE / INJECTION AP 2011-10-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091487-001 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.5% INJECTABLE / INJECTION AP 2011-10-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091487-002 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.25% INJECTABLE / INJECTION AP 2011-10-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091487-003 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.75% INJECTABLE / INJECTION AP 2011-10-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091487-001 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.5% INJECTABLE / INJECTION AP 2011-10-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091487-002 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.25% INJECTABLE / INJECTION AP 2011-10-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091487-003 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.75% INJECTABLE / INJECTION AP 2011-10-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091487-001 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.5% INJECTABLE / INJECTION AP 2011-10-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091487-002 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.25% INJECTABLE / INJECTION AP 2011-10-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091487-003 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.75% INJECTABLE / INJECTION AP 2011-10-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091487-001 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.5% INJECTABLE / INJECTION AP 2011-10-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091487-002 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.25% INJECTABLE / INJECTION AP 2011-10-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091487-003 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.75% INJECTABLE / INJECTION AP 2011-10-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091487-001 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.5% INJECTABLE / INJECTION AP 2011-10-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091487-002 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.25% INJECTABLE / INJECTION AP 2011-10-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091487-003 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.75% INJECTABLE / INJECTION AP 2011-10-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091487-001 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.5% INJECTABLE / INJECTION AP 2011-10-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091487-002 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.25% INJECTABLE / INJECTION AP 2011-10-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091487-003 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.75% INJECTABLE / INJECTION AP 2011-10-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091487-001 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.5% INJECTABLE / INJECTION AP 2011-10-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091487-002 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.25% INJECTABLE / INJECTION AP 2011-10-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091487-003 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.75% INJECTABLE / INJECTION AP 2011-10-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091487-001 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.5% INJECTABLE / INJECTION AP 2011-10-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091487-002 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.25% INJECTABLE / INJECTION AP 2011-10-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091487-003 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.75% INJECTABLE / INJECTION AP 2011-10-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091487-001 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.5% INJECTABLE / INJECTION AP 2011-10-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091487-002 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.25% INJECTABLE / INJECTION AP 2011-10-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091487-003 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.75% INJECTABLE / INJECTION AP 2011-10-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091487-001 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.5% INJECTABLE / INJECTION AP 2011-10-18 79d66fd596c7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 78 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 HCl
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 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 70594-115-01 BUPIVACAINE HCl 30 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70594-115 BUPIVACAINE HCL (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION BUPIVACAINE HCL (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION BUPIVACINE HCL (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [XELLIA PHARMACEUTICALS USA LLC] 2 Current NDC, 1 package rows 20230622_f29c905e-9a55-446f-a89d-860ad9ade7ad.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70594-115-01 70594011501 30 mL in 1 VIAL, SINGLE-DOSE (70594-115-01) 30 ml 2023-06-01 No No Current