Bupivacaine Hydrochloride

Product NDC: 71351-022
11-digit product format: 713510022
Labeler code: 71351
Product ID: 71351-022_484033d6-ca7d-f0fd-e063-6294a90a7890
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Bupivacaine hydrochloride
Dosage form: INJECTION
Route: SUBARACHNOID
Labeler: Brookfield Pharmaceuticals, LLC.
Application: ANDA212822
Marketing category: ANDA
Marketing start: 2022-10-31
Substance: BUPIVACAINE HYDROCHLORIDE
Active strength: 7.5 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 1.

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
A212822-001	BUPIVACAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP		2019-12-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212822-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A212822-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	2019-12-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212822-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	2019-12-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212822-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	2019-12-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212822-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	2019-12-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212822-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	2019-12-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212822-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	2019-12-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212822-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	2019-12-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212822-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	2019-12-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212822-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	2019-12-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212822-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	2019-12-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212822-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	2019-12-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212822-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	2019-12-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212822-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	2019-12-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212822-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	2019-12-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212822-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	2019-12-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212822-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	2019-12-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212822-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	2019-12-30	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212822-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	2019-12-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212822-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	2019-12-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212822-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	2019-12-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212822-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	2019-12-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212822-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	2019-12-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212822-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	2019-12-30	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212822-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	2019-12-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212822-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	2019-12-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212822-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	2019-12-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212822-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	2019-12-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212822-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	2019-12-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212822-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	2019-12-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212822-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	2019-12-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212822-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	2019-12-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212822-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	2019-12-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212822-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	2019-12-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212822-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	2019-12-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212822-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	2019-12-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212822-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	2019-12-30	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212822-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	2019-12-30	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A212822-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212822-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212822-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212822-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212822-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212822-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212822-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212822-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212822-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212822-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212822-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212822-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212822-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212822-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212822-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212822-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212822-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212822-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212822-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212822-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212822-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212822-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212822-001	AP	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212822-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212822-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212822-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212822-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212822-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212822-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212822-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212822-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212822-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212822-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212822-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212822-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212822-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212822-001	AP	1	`a50c72e98297…`

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	7.5 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
1724784	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
e8b32972-6984-4f1c-e053-2995a90a3277	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
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71351-022-02	Bupivacaine Hydrochloride	2 mL in 1 AMPULE	INJECTION	2	6
71351-022-10	Bupivacaine Hydrochloride	10 in 1 PACKAGE	INJECTION	10	6
71351-022-50	Bupivacaine Hydrochloride	50 in 1 PACKAGE	INJECTION	50	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71351-022-02	ML - Milliliter	71351-022	0ef2a5f0-36ff-41b6-8d0e-eb4a21c61149	1	2023-03-13
71351-022-10	ML - Milliliter	71351-022	8b364bba-f071-4b42-bee7-9826834045e4	1	2023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71351-022	BUPIVACAINE HYDROCHLORIDE INJECTION [BROOKFIELD PHARMACEUTICALS, LLC.]	4	Current NDC, Legacy NDC, 3 package rows	20241224_e8b32972-6984-4f1c-e053-2995a90a3277.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	Brookfield Pharmaceuticals, LLC.	e8b32972-6984-4f1c-e053-2995a90a3277	2026-01-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212822 application number: ANDA212822 ndc (product): 71351-022
Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	Huons Co., Ltd.	2dc693df-3218-4a90-b3f7-21e80966a851	2024-11-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212822 application number: ANDA212822

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
1724784	BUPivacaine HCl 0.75 % in 2 ML Injection	PSN	e8b32972-6984-4f1c-e053-2995a90a3277	6
1724784	2 ML bupivacaine hydrochloride 7.5 MG/ML Injection	SCD	e8b32972-6984-4f1c-e053-2995a90a3277	6
1724784	bupivacaine HCl 0.75 % per 2 ML Injection	SY	e8b32972-6984-4f1c-e053-2995a90a3277	6
1724784	bupivacaine HCl 15 MG per 2 ML Injection	SY	e8b32972-6984-4f1c-e053-2995a90a3277	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71351-022-02	71351002202	2 mL in 1 AMPULE	2 ml					Historical
71351-022-10	71351002210	10 AMPULE in 1 PACKAGE (71351-022-10) / 2 mL in 1 AMPULE (71351-022-02)	10 ampule	2023-02-23		No	No	Current
71351-022-50	71351002250	50 AMPULE in 1 PACKAGE (71351-022-50) / 2 mL in 1 AMPULE (71351-022-02)	50 ampule	2022-10-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Bupivacaine Hydrochloride in Dextrose Injection, USP STERILE HYPERBARIC SOLUTION FOR SPINAL ANESTHESIA Rx only	Brookfield Pharmaceuticals, LLC.	2026-01-13	HUMAN PRESCRIPTION DRUG LABEL	6