Bupivacaine Hydrochloride

Product NDC: 0409-1165
11-digit product format: 004091165
Labeler code: 0409
Product ID: 0409-1165_6e442bfd-d3da-4913-8585-ce3485644364
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: BUPIVACAINE HYDROCHLORIDE
Dosage form: INJECTION, SOLUTION
Route: EPIDURAL; RETROBULBAR
Labeler: Hospira, Inc.
Application: ANDA070585
Marketing category: ANDA
Marketing start: 2005-06-08
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 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
A070585-001	BUPIVACAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / INJECTION	AP		1987-03-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A070585-001	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	A070585-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / INJECTION	AP	1987-03-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A070585-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / INJECTION	AP	1987-03-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070585-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / INJECTION	AP	1987-03-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070585-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / INJECTION	AP	1987-03-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070585-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / INJECTION	AP	1987-03-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070585-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / INJECTION	AP	1987-03-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070585-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / INJECTION	AP	1987-03-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070585-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / INJECTION	AP	1987-03-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070585-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / INJECTION	AP	1987-03-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070585-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / INJECTION	AP	1987-03-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070585-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / INJECTION	AP	1987-03-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070585-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / INJECTION	AP	1987-03-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070585-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / INJECTION	AP	1987-03-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070585-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / INJECTION	AP	1987-03-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070585-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / INJECTION	AP	1987-03-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070585-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / INJECTION	AP	1987-03-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070585-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / INJECTION	AP	1987-03-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070585-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / INJECTION	AP	1987-03-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070585-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / INJECTION	AP	1987-03-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070585-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / INJECTION	AP	1987-03-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070585-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / INJECTION	AP	1987-03-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070585-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / INJECTION	AP	1987-03-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070585-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / INJECTION	AP	1987-03-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070585-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / INJECTION	AP	1987-03-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070585-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / INJECTION	AP	1987-03-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070585-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / INJECTION	AP	1987-03-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070585-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / INJECTION	AP	1987-03-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070585-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / INJECTION	AP	1987-03-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070585-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / INJECTION	AP	1987-03-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070585-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / INJECTION	AP	1987-03-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070585-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / INJECTION	AP	1987-03-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070585-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / INJECTION	AP	1987-03-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070585-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / INJECTION	AP	1987-03-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070585-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / INJECTION	AP	1987-03-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070585-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / INJECTION	AP	1987-03-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070585-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / INJECTION	AP	1987-03-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070585-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / INJECTION	AP	1987-03-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070585-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / INJECTION	AP	1987-03-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070585-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / INJECTION	AP	1987-03-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070585-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / INJECTION	AP	1987-03-03	`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	A070585-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A070585-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070585-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070585-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070585-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070585-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070585-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070585-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070585-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070585-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070585-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070585-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070585-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070585-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070585-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070585-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070585-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070585-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070585-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070585-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070585-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070585-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070585-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070585-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070585-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070585-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070585-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070585-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070585-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070585-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070585-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070585-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070585-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070585-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070585-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070585-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070585-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070585-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070585-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070585-001	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	7.5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
7TQO7W3VT8	Internal UNII lookup
30Q7KI53AK	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 14 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1012377	Internal RxNorm lookup
1012384	Internal RxNorm lookup
1012396	Internal RxNorm lookup
1012404	Internal RxNorm lookup
1672917	Internal RxNorm lookup
1672919	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
1867594	Internal RxNorm lookup
1867596	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
02a845c3-4521-4926-e397-25ab536e7cf6	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0b4ec9ca-d305-43fc-88dd-7a510313efe0	Product name	1	20260105
bb209f42-a85f-4fee-9d3d-c9dded168625	Product name	1	20251208
49628fc7-2031-4c28-bd31-0ef3aa8f44a3	Product name	3	20251118
cbf85893-59ef-423f-87d4-a573c000a8b9	Product name	8	20250731
b5b1095b-40cd-8a9e-b111-502545045b07	Product name	4	20250325
e190029e-423b-473c-8e04-2ada59b5b711	Product name	1	20250314
5dad6767-dcd1-b0da-8727-7f3f7bc3a435	Product name	2	20250303
e0031c74-3853-42bc-8e10-86dbbe83992e	Product name	2	20231116
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
f7046b89-2016-499a-adc6-78479172abc6	Product name	1	20230425
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
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
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
2686d634-e712-4007-8dbf-3d37c6c4d71f	Product name	1	20181121
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
fa8b5901-e681-426f-82fe-54f6d81ec698	Product name	4	20180619
bd49bb86-2d32-4a7a-a594-eeda2e29af42	Product name	1	20180118
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070	Product name	1	20171221
3becbe78-12d9-4ad2-9b4c-1e36f8d1303a	Product name	1	20170815
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
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	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
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	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	SPL version
0409-1165-01	Bupivacaine Hydrochloride	25 in 1 TRAY	INJECTION, SOLUTION	25	39
0409-1165-02	Bupivacaine Hydrochloride	25 in 1 TRAY	INJECTION, SOLUTION	25	39
0409-1165-18	Bupivacaine Hydrochloride	10 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	10	39
0409-1165-19	Bupivacaine Hydrochloride	30 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	30	39

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0409-1165-01	ML - Milliliter	0409-1165	71d9b433-a7cc-487b-a243-d5719c471bab	1	2012-07-24
0409-1165-02	ML - Milliliter	0409-1165	ffdeabbc-a208-4b7f-8f49-a5be534e6fb6	1	2012-07-24
0409-1165-18	ML - Milliliter	0409-1165	4fd29bf2-0cdb-457f-97c8-fdc580301d13	1	2017-07-07
0409-1165-19	ML - Milliliter	0409-1165	b015d2e2-db6d-4236-80c7-4614f28fc300	1	2017-07-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BUPIVACAINE HYDROCHLORIDE	ACTIVE INGREDIENT	7TQO7W3VT8	BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]	18
EPINEPHRINE BITARTRATE	ACTIVE INGREDIENT	30Q7KI53AK	BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]	18
BUPIVACAINE	ACTIVE MOIETY	Y8335394RO	BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]	18
EPINEPHRINE	ACTIVE MOIETY	YKH834O4BH	BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]	18
EDETATE CALCIUM DISODIUM ANHYDROUS	INACTIVE INGREDIENT	8U5D034955	BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]	18
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]	18
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]	18
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]	18
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]	18
SODIUM METABISULFITE	INACTIVE INGREDIENT	4VON5FNS3C	BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]	18
WATER	INACTIVE INGREDIENT	059QF0KO0R	BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]	18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0409-1165	BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION [HOSPIRA, INC.]	38	Current NDC, Legacy NDC, 4 package rows	20241017_02a845c3-4521-4926-e397-25ab536e7cf6.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 Hydrochloride	BUPIVACAINE HYDROCHLORIDE	Hospira, Inc.	02a845c3-4521-4926-e397-25ab536e7cf6	2026-03-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070585 application number: ANDA070585 ndc (product): 0409-1165

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
1867594	BUPivacaine HCl 0.25 % / EPINEPHrine 1:200,000 in 10 ML Injection	PSN	02a845c3-4521-4926-e397-25ab536e7cf6	39
1867596	BUPivacaine HCl 0.25 % / EPINEPHrine 1:200,000 in 30 ML Injection	PSN	02a845c3-4521-4926-e397-25ab536e7cf6	39
1012377	BUPivacaine HCl 0.25 % / EPINEPHrine 1:200,000 Injectable Solution	PSN	02a845c3-4521-4926-e397-25ab536e7cf6	39
1725078	BUPivacaine HCl 0.25 % in 10 ML Injection	PSN	02a845c3-4521-4926-e397-25ab536e7cf6	39
1725082	BUPivacaine HCl 0.25 % in 30 ML Injection	PSN	02a845c3-4521-4926-e397-25ab536e7cf6	39
1012396	BUPivacaine HCl 0.25 % Injectable Solution	PSN	02a845c3-4521-4926-e397-25ab536e7cf6	39
1672917	BUPivacaine HCl 0.5 % / EPINEPHrine 1:200,000 in 10 ML Injection	PSN	02a845c3-4521-4926-e397-25ab536e7cf6	39
1672919	BUPivacaine HCl 0.5 % / EPINEPHrine 1:200,000 in 30 ML Injection	PSN	02a845c3-4521-4926-e397-25ab536e7cf6	39
1012384	BUPivacaine HCl 0.5 % / EPINEPHrine 1:200,000 Injectable Solution	PSN	02a845c3-4521-4926-e397-25ab536e7cf6	39
1724880	BUPivacaine HCl 0.5 % in 10 ML Injection	PSN	02a845c3-4521-4926-e397-25ab536e7cf6	39
1724884	BUPivacaine HCl 0.5 % in 30 ML Injection	PSN	02a845c3-4521-4926-e397-25ab536e7cf6	39
1012404	BUPivacaine HCl 0.5 % Injectable Solution	PSN	02a845c3-4521-4926-e397-25ab536e7cf6	39
1724787	BUPivacaine HCl 0.75 % in 10 ML Injection	PSN	02a845c3-4521-4926-e397-25ab536e7cf6	39
1724786	BUPivacaine HCl 0.75 % in 30 ML Injection	PSN	02a845c3-4521-4926-e397-25ab536e7cf6	39
1867594	10 ML bupivacaine hydrochloride 2.5 MG/ML / epinephrine 0.005 MG/ML Injection	SCD	02a845c3-4521-4926-e397-25ab536e7cf6	39
1725078	10 ML bupivacaine hydrochloride 2.5 MG/ML Injection	SCD	02a845c3-4521-4926-e397-25ab536e7cf6	39
1672917	10 ML bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML Injection	SCD	02a845c3-4521-4926-e397-25ab536e7cf6	39
1724880	10 ML bupivacaine hydrochloride 5 MG/ML Injection	SCD	02a845c3-4521-4926-e397-25ab536e7cf6	39
1724787	10 ML bupivacaine hydrochloride 7.5 MG/ML Injection	SCD	02a845c3-4521-4926-e397-25ab536e7cf6	39
1867596	30 ML bupivacaine hydrochloride 2.5 MG/ML / epinephrine 0.005 MG/ML Injection	SCD	02a845c3-4521-4926-e397-25ab536e7cf6	39
1725082	30 ML bupivacaine hydrochloride 2.5 MG/ML Injection	SCD	02a845c3-4521-4926-e397-25ab536e7cf6	39
1672919	30 ML bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML Injection	SCD	02a845c3-4521-4926-e397-25ab536e7cf6	39
1724884	30 ML bupivacaine hydrochloride 5 MG/ML Injection	SCD	02a845c3-4521-4926-e397-25ab536e7cf6	39
1724786	30 ML bupivacaine hydrochloride 7.5 MG/ML Injection	SCD	02a845c3-4521-4926-e397-25ab536e7cf6	39
1012377	bupivacaine hydrochloride 2.5 MG/ML / epinephrine 0.005 MG/ML Injectable Solution	SCD	02a845c3-4521-4926-e397-25ab536e7cf6	39
1012396	bupivacaine hydrochloride 2.5 MG/ML Injectable Solution	SCD	02a845c3-4521-4926-e397-25ab536e7cf6	39
1012384	bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML Injectable Solution	SCD	02a845c3-4521-4926-e397-25ab536e7cf6	39
1012404	bupivacaine hydrochloride 5 MG/ML Injectable Solution	SCD	02a845c3-4521-4926-e397-25ab536e7cf6	39
1867594	bupivacaine HCl 0.25 % / epinephrine (as bitartrate) 1:200,000 per 10 mL Injection	SY	02a845c3-4521-4926-e397-25ab536e7cf6	39
1867596	bupivacaine HCl 0.25 % / epinephrine 1:200,000 per 30 ML Injection	SY	02a845c3-4521-4926-e397-25ab536e7cf6	39
1725078	bupivacaine HCl 0.25 % in 10 ML Injection	SY	02a845c3-4521-4926-e397-25ab536e7cf6	39
1725082	bupivacaine HCl 0.25 % per 30 ML Injection	SY	02a845c3-4521-4926-e397-25ab536e7cf6	39
1672917	bupivacaine HCl 0.5 % / epinephrine (as bitartrate) 1:200,000 per 10 ML Injection	SY	02a845c3-4521-4926-e397-25ab536e7cf6	39
1672919	bupivacaine HCl 0.5 % / epinephrine (as bitartrate) 1:200,000 per 30 ML Injection	SY	02a845c3-4521-4926-e397-25ab536e7cf6	39
1724880	bupivacaine HCl 0.5 % in 10 ML Injection	SY	02a845c3-4521-4926-e397-25ab536e7cf6	39
1724884	bupivacaine HCl 0.5 % in 30 ML Injection	SY	02a845c3-4521-4926-e397-25ab536e7cf6	39
1724787	bupivacaine HCl 0.75 % in 10 ML Injection	SY	02a845c3-4521-4926-e397-25ab536e7cf6	39
1724786	bupivacaine HCl 0.75 % in 30 ML Injection	SY	02a845c3-4521-4926-e397-25ab536e7cf6	39
1724786	bupivacaine HCl 225 MG per 30 ML Injection	SY	02a845c3-4521-4926-e397-25ab536e7cf6	39
1724787	bupivacaine HCl 75 MG per 10 ML Injection	SY	02a845c3-4521-4926-e397-25ab536e7cf6	39
1012377	bupivacaine hydrochloride 0.25 % / epinephrine (as epinephrine bitartrate) 1:200,000 Injectable Solution	SY	02a845c3-4521-4926-e397-25ab536e7cf6	39
1012396	bupivacaine hydrochloride 0.25 % Injectable Solution	SY	02a845c3-4521-4926-e397-25ab536e7cf6	39
1012384	bupivacaine hydrochloride 0.5 % / epinephrine (as epinephrine bitartrate) 1:200,000 Injectable Solution	SY	02a845c3-4521-4926-e397-25ab536e7cf6	39
1012404	bupivacaine hydrochloride 0.5 % Injectable Solution	SY	02a845c3-4521-4926-e397-25ab536e7cf6	39

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0409-1165-01	00409116501	25 VIAL, SINGLE-DOSE in 1 TRAY (0409-1165-01) / 10 mL in 1 VIAL, SINGLE-DOSE (0409-1165-18)		2005-12-06	0000-00-00	No	No	Current
0409-1165-02	00409116502	25 VIAL, SINGLE-DOSE in 1 TRAY (0409-1165-02) / 30 mL in 1 VIAL, SINGLE-DOSE (0409-1165-19)		2005-06-08	0000-00-00	No	No	Current
0409-1165-18	00409116518	10 mL in 1 VIAL, SINGLE-DOSE	10 ml					Historical
0409-1165-19	00409116519	30 mL in 1 VIAL, SINGLE-DOSE	30 ml					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Bupivacaine Hydrochloride	Hospira, Inc. \| Pfizer Healthcare India Private Limited	2026-03-09	HUMAN PRESCRIPTION DRUG LABEL	39