Bupivacaine Hydrochloride

Product NDC: 55154-6970
11-digit product format: 551546970
Labeler code: 55154
Product ID: 55154-6970_b7c59485-ee18-4779-b212-cda5e0b7a331
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: BUPIVACAINE HYDROCHLORIDE
Dosage form: INJECTION, SOLUTION
Route: EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL
Labeler: Cardinal Health 107, LLC
Application: ANDA070583
Marketing category: ANDA
Marketing start: 2010-01-06
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: 2027-12-31
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A070583-001	BUPIVACAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP		1987-02-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A070583-001	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 2 · 42 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	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A070583-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A070583-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070583-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070583-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070583-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070583-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070583-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070583-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070583-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070583-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070583-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070583-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070583-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070583-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070583-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070583-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070583-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070583-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070583-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070583-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070583-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070583-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070583-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070583-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070583-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070583-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070583-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070583-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070583-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070583-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070583-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070583-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070583-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070583-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070583-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070583-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070583-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070583-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070583-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070583-001	AP	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Bupivacaine Hydrochloride
Listing expiration: 2027-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
8f8f4ece-de78-4c13-8d9f-c3bb7053019d	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
55154-6970-5	Bupivacaine Hydrochloride	30 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	30		17
55154-6970-5	Bupivacaine Hydrochloride	5 in 1 BAG	INJECTION, SOLUTION	5		17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BUPIVACAINE HYDROCHLORIDE	ACTIVE INGREDIENT	7TQO7W3VT8	BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [CARDINAL HEALTH]	5
BUPIVACAINE	ACTIVE MOIETY	Y8335394RO	BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [CARDINAL HEALTH]	5
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [CARDINAL HEALTH]	5
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [CARDINAL HEALTH]	5
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [CARDINAL HEALTH]	5
WATER	INACTIVE INGREDIENT	059QF0KO0R	BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [CARDINAL HEALTH]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55154-6970	BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [CARDINAL HEALTH 107, LLC]	15	Current NDC, Legacy NDC, 2 package rows	20241018_8f8f4ece-de78-4c13-8d9f-c3bb7053019d.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	Sportpharm LLC	6f9ebeef-350a-495e-a0bf-c335ab48bf1c	2026-04-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070583 application number: ANDA070583
Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	Cardinal Health 107, LLC	8f8f4ece-de78-4c13-8d9f-c3bb7053019d	2026-04-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070583 application number: ANDA070583 ndc (product): 55154-6970
BUPIVACAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	Hospira, Inc.	bb44c7e1-d911-4788-908f-09b7b271969b	2026-04-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070583 application number: ANDA070583
Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	Hospira, Inc.	02a845c3-4521-4926-e397-25ab536e7cf6	2026-03-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070583 application number: ANDA070583
Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	ProPharma Distribution	3f7ab295-6429-4760-e063-6294a90a781f	2025-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070583 application number: ANDA070583
BUPIVICAINE HYDROCHLORIDE	BUPIVICAINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	99857946-6084-1bbd-e053-2a95a90af58c	2020-10-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070583 application number: ANDA070583

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
1725082	BUPivacaine HCl 0.25 % in 30 ML Injection	PSN	8f8f4ece-de78-4c13-8d9f-c3bb7053019d	17
1725082	30 ML bupivacaine hydrochloride 2.5 MG/ML Injection	SCD	8f8f4ece-de78-4c13-8d9f-c3bb7053019d	17
1725082	bupivacaine HCl 0.25 % per 30 ML Injection	SY	8f8f4ece-de78-4c13-8d9f-c3bb7053019d	17

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
55154-6970-5	55154697005	5 VIAL, SINGLE-DOSE in 1 BAG (55154-6970-5) / 30 mL in 1 VIAL, SINGLE-DOSE	2010-01-06	0000-00-00	No	No	Current