Bupivacaine Hydrochloride

Product NDC: 55150-250
11-digit product format: 551500250
Labeler code: 55150
Product ID: 55150-250_39649703-e633-4a20-ba71-0c04dbf8ff2a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Bupivacaine Hydrochloride
Dosage form: INJECTION, SOLUTION
Route: PERINEURAL
Labeler: Eugia US LLC
Application: ANDA207183
Marketing category: ANDA
Marketing start: 2016-05-13
Substance: BUPIVACAINE HYDROCHLORIDE
Active strength: 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
A207183-001	BUPIVACAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP		2016-05-13
A207183-002	BUPIVACAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP		2016-05-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A207183-001	AP
A207183-002	AP

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 3 · 84 observed 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
2026-08-18 06:07:40	2026-07	A207183-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2016-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207183-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2016-05-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207183-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2016-05-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207183-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2016-05-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207183-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2016-05-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207183-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2016-05-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207183-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2016-05-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207183-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2016-05-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207183-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2016-05-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207183-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2016-05-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207183-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2016-05-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207183-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2016-05-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207183-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2016-05-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207183-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2016-05-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207183-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2016-05-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207183-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2016-05-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207183-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2016-05-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207183-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2016-05-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207183-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2016-05-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207183-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2016-05-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207183-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2016-05-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207183-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2016-05-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207183-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2016-05-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207183-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2016-05-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207183-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2016-05-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207183-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2016-05-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207183-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2016-05-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207183-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2016-05-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207183-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2016-05-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207183-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2016-05-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207183-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2016-05-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207183-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2016-05-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207183-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2016-05-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207183-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2016-05-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207183-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2016-05-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207183-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2016-05-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207183-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2016-05-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207183-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2016-05-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207183-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2016-05-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207183-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2016-05-13	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A207183-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207183-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207183-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207183-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207183-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207183-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207183-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207183-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207183-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207183-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207183-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207183-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207183-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207183-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207183-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207183-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207183-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207183-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207183-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207183-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207183-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207183-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207183-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207183-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207183-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207183-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207183-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207183-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207183-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207183-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207183-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207183-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207183-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207183-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207183-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207183-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207183-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207183-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207183-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207183-002	AP	1	`bb7c543d1eb4…`

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	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 · 8 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1012396	Internal RxNorm lookup
1012404	Internal RxNorm lookup
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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
ffecf450-1f01-4721-8e10-251385852612	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
1ea46721-9071-6b81-fd0a-a82bfbb014ec	Product name	7	20250220
525701df-f985-480d-995a-e0ee70c2bdf4	Product name	5	20250128
ea50b939-d92a-4100-84f5-1c1089663837	Product name	2	20240705
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
941f67d9-7f03-56d2-750c-36de24f654db	Product name	3	20221117
d7d46a10-8766-d3c8-ebf2-2ccd9efdcae8	Product name	2	20220506
7b2c58e8-5850-4e3e-82e9-b1593b1de761	Product name	5	20220210
e3a99641-4540-4894-9108-00cab3c57b7e	Product name	1	20211207
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
5da98533-f072-406b-9e1b-6ac19eca9926	Product name	1	20210622
306b993e-3140-4823-ad5e-88b708f9d2ac	Product name	1	20210510
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
a831e694-3663-4a83-82be-6c309429f750	Product name	2	20200608
81e34474-b0a5-434f-8104-25d689efc99e	Product name	1	20200303
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
05ab9c01-cd9a-4f59-b2e8-ddcb887cac39	Product name	1	20190408
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
0c7dba41-c919-5809-508d-4affe6cfcff2	Product name	2	20170817
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
399647c0-db89-02d1-991c-0c17b584482c	Product name	1	20140508
3e9a6377-704f-dff7-b19f-56c98d40c444	Product name	1	20140508
4d2e6ff9-14f5-b84f-c39b-373b005712c1	Product name	1	20140508
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
725d71bf-f956-5cad-e556-fa39cb060dc8	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
9ea85abb-fa68-5da6-ab60-2c7eef579000	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
d029211e-5e6b-725f-3696-ac6ff77da222	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55150-250-50	Bupivacaine Hydrochloride	50 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	50		9
55150-250-50	Bupivacaine Hydrochloride	25 in 1 CARTON	INJECTION, SOLUTION	25		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55150-250-50	ML - Milliliter	55150-250	d8117f97-6d25-4106-a667-064c9ec26584	1	2017-10-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BUPIVACAINE HYDROCHLORIDE	ACTIVE INGREDIENT	7TQO7W3VT8	BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [AUROMEDICS PHARMA LLC]	3
BUPIVACAINE	ACTIVE MOIETY	Y8335394RO	BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [AUROMEDICS PHARMA LLC]	3
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [AUROMEDICS PHARMA LLC]	3
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [AUROMEDICS PHARMA LLC]	3
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [AUROMEDICS PHARMA LLC]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [AUROMEDICS PHARMA LLC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55150-250	BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [EUGIA US LLC]	9	Current NDC, Legacy NDC, 2 package rows	20250516_ffecf450-1f01-4721-8e10-251385852612.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	Eugia US LLC	ffecf450-1f01-4721-8e10-251385852612	2025-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207183 application number: ANDA207183 ndc (product): 55150-250
Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	A-S Medication Solutions	1091d4d8-5dad-46e1-8f26-7bc0c5dd833f	2024-05-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207183 application number: ANDA207183
BUPIVACAINE HCI	BUPIVACAINE HCI	HF Acquisition Co LLC, DBA HealthFirst	e37e1599-db88-2fcd-e053-2995a90a00e5	2024-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207183 application number: ANDA207183
BUPIVACAINE HYDROCHLORIDE injection, solution	BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION	HF Acquisition Co LLC, DBA HealthFirst	06c15208-c600-7173-e063-6394a90a2f94	2024-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207183 application number: ANDA207183
Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	694926ac-aff0-aa1f-e053-2991aa0a9588	2023-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207183 application number: ANDA207183
Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	d1642239-4230-b679-e053-2a95a90a3b7c	2023-05-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207183 application number: ANDA207183

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7TQO7W3VT8	BUPIVACAINE HYDROCHLORIDE	73360-54-0	BUPIVACAINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1725078	BUPivacaine HCl 0.25 % in 10 ML Injection	PSN	ffecf450-1f01-4721-8e10-251385852612	9
1725082	BUPivacaine HCl 0.25 % in 30 ML Injection	PSN	ffecf450-1f01-4721-8e10-251385852612	9
1012396	BUPivacaine HCl 0.25 % Injectable Solution	PSN	ffecf450-1f01-4721-8e10-251385852612	9
1724880	BUPivacaine HCl 0.5 % in 10 ML Injection	PSN	ffecf450-1f01-4721-8e10-251385852612	9
1724884	BUPivacaine HCl 0.5 % in 30 ML Injection	PSN	ffecf450-1f01-4721-8e10-251385852612	9
1012404	BUPivacaine HCl 0.5 % Injectable Solution	PSN	ffecf450-1f01-4721-8e10-251385852612	9
1724787	BUPivacaine HCl 0.75 % in 10 ML Injection	PSN	ffecf450-1f01-4721-8e10-251385852612	9
1724786	BUPivacaine HCl 0.75 % in 30 ML Injection	PSN	ffecf450-1f01-4721-8e10-251385852612	9
1725078	10 ML bupivacaine hydrochloride 2.5 MG/ML Injection	SCD	ffecf450-1f01-4721-8e10-251385852612	9
1724880	10 ML bupivacaine hydrochloride 5 MG/ML Injection	SCD	ffecf450-1f01-4721-8e10-251385852612	9
1724787	10 ML bupivacaine hydrochloride 7.5 MG/ML Injection	SCD	ffecf450-1f01-4721-8e10-251385852612	9
1725082	30 ML bupivacaine hydrochloride 2.5 MG/ML Injection	SCD	ffecf450-1f01-4721-8e10-251385852612	9
1724884	30 ML bupivacaine hydrochloride 5 MG/ML Injection	SCD	ffecf450-1f01-4721-8e10-251385852612	9
1724786	30 ML bupivacaine hydrochloride 7.5 MG/ML Injection	SCD	ffecf450-1f01-4721-8e10-251385852612	9
1012396	bupivacaine hydrochloride 2.5 MG/ML Injectable Solution	SCD	ffecf450-1f01-4721-8e10-251385852612	9
1012404	bupivacaine hydrochloride 5 MG/ML Injectable Solution	SCD	ffecf450-1f01-4721-8e10-251385852612	9
1725078	bupivacaine HCl 0.25 % in 10 ML Injection	SY	ffecf450-1f01-4721-8e10-251385852612	9
1725082	bupivacaine HCl 0.25 % per 30 ML Injection	SY	ffecf450-1f01-4721-8e10-251385852612	9
1724880	bupivacaine HCl 0.5 % in 10 ML Injection	SY	ffecf450-1f01-4721-8e10-251385852612	9
1724884	bupivacaine HCl 0.5 % in 30 ML Injection	SY	ffecf450-1f01-4721-8e10-251385852612	9
1724787	bupivacaine HCl 0.75 % in 10 ML Injection	SY	ffecf450-1f01-4721-8e10-251385852612	9
1724786	bupivacaine HCl 0.75 % in 30 ML Injection	SY	ffecf450-1f01-4721-8e10-251385852612	9
1724786	bupivacaine HCl 225 MG per 30 ML Injection	SY	ffecf450-1f01-4721-8e10-251385852612	9
1724787	bupivacaine HCl 75 MG per 10 ML Injection	SY	ffecf450-1f01-4721-8e10-251385852612	9
1012396	bupivacaine hydrochloride 0.25 % Injectable Solution	SY	ffecf450-1f01-4721-8e10-251385852612	9
1012404	bupivacaine hydrochloride 0.5 % Injectable Solution	SY	ffecf450-1f01-4721-8e10-251385852612	9
1012404	BUPivacaine HCl 0.5 % Injectable Solution	PSN	1091d4d8-5dad-46e1-8f26-7bc0c5dd833f	8
1012404	bupivacaine hydrochloride 5 MG/ML Injectable Solution	SCD	1091d4d8-5dad-46e1-8f26-7bc0c5dd833f	8
1012404	bupivacaine hydrochloride 0.5 % Injectable Solution	SY	1091d4d8-5dad-46e1-8f26-7bc0c5dd833f	8
1012404	BUPivacaine HCl 0.5 % Injectable Solution	PSN	d19bf48e-b64e-4fe4-82ab-12cb444e92c4	3
1116927	dexAMETHasone sodium phosphate 4 MG/ML (dexAMETHasone phosphate equivalent) Injectable Solution	PSN	d19bf48e-b64e-4fe4-82ab-12cb444e92c4	3
1012404	bupivacaine hydrochloride 5 MG/ML Injectable Solution	SCD	d19bf48e-b64e-4fe4-82ab-12cb444e92c4	3
1116927	dexamethasone phosphate 4 MG/ML Injectable Solution	SCD	d19bf48e-b64e-4fe4-82ab-12cb444e92c4	3
1012404	bupivacaine hydrochloride 0.5 % Injectable Solution	SY	d19bf48e-b64e-4fe4-82ab-12cb444e92c4	3
1116927	dexamethasone phosphate 4 MG/ML (as dexamethasone sodium phosphate 4.4 MG/ML) Injectable Solution	SY	d19bf48e-b64e-4fe4-82ab-12cb444e92c4	3
1012404	BUPivacaine HCl 0.5 % Injectable Solution	PSN	d1642239-4230-b679-e053-2a95a90a3b7c	2
1012404	BUPivacaine HCl 0.5 % Injectable Solution	PSN	06c15208-c600-7173-e063-6394a90a2f94	2
1012404	bupivacaine hydrochloride 5 MG/ML Injectable Solution	SCD	d1642239-4230-b679-e053-2a95a90a3b7c	2
1012404	bupivacaine hydrochloride 5 MG/ML Injectable Solution	SCD	06c15208-c600-7173-e063-6394a90a2f94	2
1012404	bupivacaine hydrochloride 0.5 % Injectable Solution	SY	06c15208-c600-7173-e063-6394a90a2f94	2
1012404	bupivacaine hydrochloride 0.5 % Injectable Solution	SY	d1642239-4230-b679-e053-2a95a90a3b7c	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
55150-250-50	55150025050	25 VIAL, MULTI-DOSE in 1 CARTON (55150-250-50) / 50 mL in 1 VIAL, MULTI-DOSE	2016-05-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Bupivacaine Hydrochloride	Eugia US LLC \| EUGIA PHARMA SPECIALITIES LIMITED	2025-05-29	Human Prescription Drug Label	9
Bupivacaine Hydrochloride	A-S Medication Solutions	2024-05-31	Human Prescription Drug Label	8
BUPIVACAINE HYDROCHLORIDE - HF Acquisition Co LLC, DBA HealthFirst	HF Acquisition Co LLC, DBA HealthFirst	2024-01-22	HUMAN PRESCRIPTION DRUG LABEL	2
Bupivacaine Hydrochloride - Medical Purchasing Solutions, LLC	Medical Purchasing Solutions, LLC	2023-05-02	HUMAN PRESCRIPTION DRUG LABEL	2
Ludaxine Injection System	IT3 Medical LLC	2022-02-24	Human Prescription Drug Label	3
Bupivacaine Hydrochloride - AuroMedics Pharma LLC \| Aurobindo Pharma Limited	AuroMedics Pharma LLC \| Aurobindo Pharma Limited	2019-03-01	Human Prescription Drug Label	3