Home NDC 57884-3252 Bupivacaine
Product NDC 57884-3252
11-digit product format 578843252
Labeler code 57884
Product ID 57884-3252_1c5d9dbb-0d16-6893-e063-6394a90ad989
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bupivacaine
Dosage form INJECTION, SUSPENSION, LIPOSOMAL
Route INFILTRATION
Labeler Jiangsu Hengrui Pharmaceuticals Co., Ltd.
Application ANDA214348
Marketing category ANDA
Marketing start 2024-07-01
Substance BUPIVACAINE
Active strength 13.3 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 A214348-001 BUPIVACAINE LIPOSOME BUPIVACAINE 133MG/10ML (13.3MG/ML) INJECTABLE, LIPOSOMAL / INJECTION 2024-07-01 A214348-002 BUPIVACAINE LIPOSOME BUPIVACAINE 266MG/20ML (13.3MG/ML) INJECTABLE, LIPOSOMAL / INJECTION 2024-07-01
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 A214348-001 BUPIVACAINE LIPOSOME 133MG/10ML (13.3MG/ML) INJECTABLE, LIPOSOMAL / INJECTION 2024-07-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214348-002 BUPIVACAINE LIPOSOME 266MG/20ML (13.3MG/ML) INJECTABLE, LIPOSOMAL / INJECTION 2024-07-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214348-001 BUPIVACAINE LIPOSOME 133MG/10ML (13.3MG/ML) INJECTABLE, LIPOSOMAL / INJECTION 2024-07-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214348-002 BUPIVACAINE LIPOSOME 266MG/20ML (13.3MG/ML) INJECTABLE, LIPOSOMAL / INJECTION 2024-07-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214348-001 BUPIVACAINE LIPOSOME 133MG/10ML (13.3MG/ML) INJECTABLE, LIPOSOMAL / INJECTION 2024-07-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214348-002 BUPIVACAINE LIPOSOME 266MG/20ML (13.3MG/ML) INJECTABLE, LIPOSOMAL / INJECTION 2024-07-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214348-001 BUPIVACAINE LIPOSOME 133MG/10ML (13.3MG/ML) INJECTABLE, LIPOSOMAL / INJECTION AP 2024-07-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214348-002 BUPIVACAINE LIPOSOME 266MG/20ML (13.3MG/ML) INJECTABLE, LIPOSOMAL / INJECTION AP 2024-07-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214348-001 BUPIVACAINE LIPOSOME 133MG/10ML (13.3MG/ML) INJECTABLE, LIPOSOMAL / INJECTION AP 2024-07-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214348-002 BUPIVACAINE LIPOSOME 266MG/20ML (13.3MG/ML) INJECTABLE, LIPOSOMAL / INJECTION AP 2024-07-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214348-001 BUPIVACAINE LIPOSOME 133MG/10ML (13.3MG/ML) INJECTABLE, LIPOSOMAL / INJECTION AP 2024-07-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214348-002 BUPIVACAINE LIPOSOME 266MG/20ML (13.3MG/ML) INJECTABLE, LIPOSOMAL / INJECTION AP 2024-07-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214348-001 BUPIVACAINE LIPOSOME 133MG/10ML (13.3MG/ML) INJECTABLE, LIPOSOMAL / INJECTION AP 2024-07-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214348-002 BUPIVACAINE LIPOSOME 266MG/20ML (13.3MG/ML) INJECTABLE, LIPOSOMAL / INJECTION AP 2024-07-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214348-001 BUPIVACAINE LIPOSOME 133MG/10ML (13.3MG/ML) INJECTABLE, LIPOSOMAL / INJECTION AP 2024-07-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214348-002 BUPIVACAINE LIPOSOME 266MG/20ML (13.3MG/ML) INJECTABLE, LIPOSOMAL / INJECTION AP 2024-07-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214348-001 BUPIVACAINE LIPOSOME 133MG/10ML (13.3MG/ML) INJECTABLE, LIPOSOMAL / INJECTION AP 2024-07-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214348-002 BUPIVACAINE LIPOSOME 266MG/20ML (13.3MG/ML) INJECTABLE, LIPOSOMAL / INJECTION AP 2024-07-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214348-001 BUPIVACAINE LIPOSOME 133MG/10ML (13.3MG/ML) INJECTABLE, LIPOSOMAL / INJECTION AP 2024-07-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214348-002 BUPIVACAINE LIPOSOME 266MG/20ML (13.3MG/ML) INJECTABLE, LIPOSOMAL / INJECTION AP 2024-07-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214348-001 BUPIVACAINE LIPOSOME 133MG/10ML (13.3MG/ML) INJECTABLE, LIPOSOMAL / INJECTION AP 2024-07-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A214348-002 BUPIVACAINE LIPOSOME 266MG/20ML (13.3MG/ML) INJECTABLE, LIPOSOMAL / INJECTION AP 2024-07-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214348-001 BUPIVACAINE LIPOSOME 133MG/10ML (13.3MG/ML) INJECTABLE, LIPOSOMAL / INJECTION AP 2024-07-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214348-002 BUPIVACAINE LIPOSOME 266MG/20ML (13.3MG/ML) INJECTABLE, LIPOSOMAL / INJECTION AP 2024-07-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214348-001 BUPIVACAINE LIPOSOME 133MG/10ML (13.3MG/ML) INJECTABLE, LIPOSOMAL / INJECTION AP 2024-07-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214348-002 BUPIVACAINE LIPOSOME 266MG/20ML (13.3MG/ML) INJECTABLE, LIPOSOMAL / INJECTION AP 2024-07-01 301d65b070ca…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214348-001 BUPIVACAINE LIPOSOME 133MG/10ML (13.3MG/ML) INJECTABLE, LIPOSOMAL / INJECTION 2024-07-01 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214348-002 BUPIVACAINE LIPOSOME 266MG/20ML (13.3MG/ML) INJECTABLE, LIPOSOMAL / INJECTION 2024-07-01 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Bupivacaine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BUPIVACAINE 13.3 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination Y8335394RO Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1191508 Internal RxNorm lookup 1745061 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 57884-3252-1 Bupivacaine 20 mL in 1 VIAL INJECTION, SUSPENSION, LIPOSOMAL 20 4 57884-3252-1 Bupivacaine 10 in 1 CARTON INJECTION, SUSPENSION, LIPOSOMAL 10 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57884-3252 BUPIVACAINE INJECTION, SUSPENSION, LIPOSOMAL [JIANGSU HENGRUI PHARMACEUTICALS CO., LTD.] 4 Current NDC, 2 package rows 20240711_0af296bb-1599-4b35-b66b-994924d3e898.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 57884-3252-1 57884325201 10 VIAL in 1 CARTON (57884-3252-1) / 20 mL in 1 VIAL 10 vial 2024-07-01 No No Current