Home NDC 70069-752 Bupivacaine hydrochloride
Product NDC 70069-752
11-digit product format 700690752
Labeler code 70069
Product ID 70069-752_2b24af95-6f20-4945-bf8c-742f1d6f2721
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bupivacaine hydrochloride
Dosage form INJECTION, SOLUTION
Route INFILTRATION; PERINEURAL
Labeler Somerset Therapeutics, LLC
Application ANDA217792
Marketing category ANDA
Marketing start 2023-11-27
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 42 .
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 A217792-001 BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 2023-11-20 A217792-002 BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 2023-11-20
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.
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 2026-08-18 06:07:40 2026-07 A217792-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 2023-11-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217792-002 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 2023-11-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217792-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 2023-11-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217792-002 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 2023-11-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217792-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 2023-11-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217792-002 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 2023-11-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217792-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 2023-11-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217792-002 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 2023-11-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217792-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 2023-11-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217792-002 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 2023-11-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217792-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 2023-11-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217792-002 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 2023-11-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217792-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 2023-11-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217792-002 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 2023-11-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217792-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 2023-11-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217792-002 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 2023-11-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217792-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 2023-11-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217792-002 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 2023-11-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217792-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 2023-11-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217792-002 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 2023-11-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217792-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 2023-11-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A217792-002 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 2023-11-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217792-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 2023-11-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217792-002 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 2023-11-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217792-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 2023-11-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217792-002 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 2023-11-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217792-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 2023-11-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217792-002 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 2023-11-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A217792-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 2023-11-20 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A217792-002 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 2023-11-20 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217792-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 2023-11-20 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217792-002 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 2023-11-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A217792-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 2023-11-20 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A217792-002 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 2023-11-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A217792-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 2023-11-20 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A217792-002 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 2023-11-20 ea1830bbd6c7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217792-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 2023-11-20 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217792-002 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 2023-11-20 a50c72e98297…
Observed Orange Book normalized TE history# 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 70069-752-01 Bupivacaine hydrochloride 50 mL in 1 VIAL INJECTION, SOLUTION 50 4 70069-752-01 Bupivacaine hydrochloride 1 in 1 CARTON INJECTION, SOLUTION 1 4 70069-752-10 Bupivacaine hydrochloride 50 mL in 1 VIAL INJECTION, SOLUTION 50 4 70069-752-10 Bupivacaine hydrochloride 10 in 1 CARTON INJECTION, SOLUTION 10 4 70069-752-25 Bupivacaine hydrochloride 25 in 1 CARTON INJECTION, SOLUTION 25 4 70069-752-25 Bupivacaine hydrochloride 50 mL in 1 VIAL INJECTION, SOLUTION 50 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70069-752 BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [SOMERSET THERAPEUTICS, LLC] 4 Current NDC, 6 package rows 20240621_bcaab86f-20f0-4482-8d73-e29b36dced58.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 Sample Exclude flag Status 70069-752-01 70069075201 1 VIAL in 1 CARTON (70069-752-01) / 50 mL in 1 VIAL 1 vial 2024-05-16 No No Current 70069-752-10 70069075210 10 VIAL in 1 CARTON (70069-752-10) / 50 mL in 1 VIAL 10 vial 2024-05-30 No No Current 70069-752-25 70069075225 25 VIAL in 1 CARTON (70069-752-25) / 50 mL in 1 VIAL 25 vial 2023-11-27 No No Current