Bupivacaine

Product NDC: 57884-3251
11-digit product format: 578843251
Labeler code: 57884
Product ID: 57884-3251_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 44.

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	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A214348-001	BUPIVACAINE LIPOSOME	133MG/10ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION		2024-07-01	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A214348-002	BUPIVACAINE LIPOSOME	266MG/20ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION		2024-07-01	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A214348-001	BUPIVACAINE LIPOSOME	133MG/10ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION		2024-07-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214348-002	BUPIVACAINE LIPOSOME	266MG/20ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION		2024-07-01	`84e616aacf4f…`
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#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A214348-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214348-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214348-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214348-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214348-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214348-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214348-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214348-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214348-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214348-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214348-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214348-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214348-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214348-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214348-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214348-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214348-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214348-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214348-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214348-002	AP	1	`301d65b070ca…`

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
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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0af296bb-1599-4b35-b66b-994924d3e898	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
cbf85893-59ef-423f-87d4-a573c000a8b9	Product name	8	20250731
5dad6767-dcd1-b0da-8727-7f3f7bc3a435	Product name	2	20250303
e3a99641-4540-4894-9108-00cab3c57b7e	Product name	1	20211207
5da98533-f072-406b-9e1b-6ac19eca9926	Product name	1	20210622
306b993e-3140-4823-ad5e-88b708f9d2ac	Product name	1	20210510
a831e694-3663-4a83-82be-6c309429f750	Product name	2	20200608

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57884-3251-1	Bupivacaine	10 mL in 1 VIAL	INJECTION, SUSPENSION, LIPOSOMAL	10		4
57884-3251-1	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
57884-3251	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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bupivacaine	BUPIVACAINE	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	0af296bb-1599-4b35-b66b-994924d3e898	2024-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214348 application number: ANDA214348 ndc (product): 57884-3251

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
Y8335394RO	BUPIVACAINE	38396-39-3	BUPIVACAINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1745061	BUPivacaine liposome 1.3 % in 10 ML Injection	PSN	0af296bb-1599-4b35-b66b-994924d3e898	4
1191508	BUPivacaine liposome 1.3 % in 20 ML Injection	PSN	0af296bb-1599-4b35-b66b-994924d3e898	4
1745061	10 ML bupivacaine liposome 13.3 MG/ML Injection	SCD	0af296bb-1599-4b35-b66b-994924d3e898	4
1191508	20 ML bupivacaine liposome 13.3 MG/ML Injection	SCD	0af296bb-1599-4b35-b66b-994924d3e898	4
1191508	bupivacaine liposome 1.3 % in 20 ML Injection	SY	0af296bb-1599-4b35-b66b-994924d3e898	4
1745061	bupivacaine liposome 133 MG per 10 ML Injection	SY	0af296bb-1599-4b35-b66b-994924d3e898	4
1191508	bupivacaine liposome 266 MG per 20 ML Injection	SY	0af296bb-1599-4b35-b66b-994924d3e898	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
57884-3251-1	57884325101	10 VIAL in 1 CARTON (57884-3251-1) / 10 mL in 1 VIAL	10 vial	2024-07-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Bupivacaine	Jiangsu Hengrui Pharmaceuticals Co., Ltd. \| Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Jinqiao Road Site) \| Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Dongjin Road Site)	2024-07-09	HUMAN PRESCRIPTION DRUG LABEL	4