Bupivacaine Hydrochloride

Product NDC: 0143-9331
11-digit product format: 001439331
Labeler code: 0143
Product ID: 0143-9331_1f5e723d-d695-4460-8142-713a5d621cff
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Bupivacaine Hydrochloride
Dosage form: INJECTION, SOLUTION
Route: EPIDURAL; INTRACAUDAL; PERINEURAL
Labeler: Hikma Pharmaceuticals USA Inc.
Application: ANDA204842
Marketing category: ANDA
Marketing start: 2021-02-11
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A204842-001	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2021-02-11
A204842-002	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2021-02-11
A204842-003	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / INJECTION	AP	2021-02-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A204842-001	AP
A204842-002	AP
A204842-003	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 · 105 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	A204842-001	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.25%	INJECTABLE / INJECTION	AP	2021-02-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204842-002	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.5%	INJECTABLE / INJECTION	AP	2021-02-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204842-003	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.75%	INJECTABLE / INJECTION	AP	2021-02-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204842-001	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.25%	INJECTABLE / INJECTION	AP	2021-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204842-002	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.5%	INJECTABLE / INJECTION	AP	2021-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204842-003	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.75%	INJECTABLE / INJECTION	AP	2021-02-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204842-001	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.25%	INJECTABLE / INJECTION	AP	2021-02-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204842-002	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.5%	INJECTABLE / INJECTION	AP	2021-02-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204842-003	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.75%	INJECTABLE / INJECTION	AP	2021-02-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204842-001	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.25%	INJECTABLE / INJECTION	AP	2021-02-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204842-002	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.5%	INJECTABLE / INJECTION	AP	2021-02-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204842-003	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.75%	INJECTABLE / INJECTION	AP	2021-02-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204842-001	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.25%	INJECTABLE / INJECTION	AP	2021-02-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204842-002	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.5%	INJECTABLE / INJECTION	AP	2021-02-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204842-003	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.75%	INJECTABLE / INJECTION	AP	2021-02-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204842-001	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.25%	INJECTABLE / INJECTION	AP	2021-02-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204842-002	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.5%	INJECTABLE / INJECTION	AP	2021-02-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204842-003	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.75%	INJECTABLE / INJECTION	AP	2021-02-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204842-001	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.25%	INJECTABLE / INJECTION	AP	2021-02-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204842-002	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.5%	INJECTABLE / INJECTION	AP	2021-02-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204842-003	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.75%	INJECTABLE / INJECTION	AP	2021-02-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204842-001	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.25%	INJECTABLE / INJECTION	AP	2021-02-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204842-002	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.5%	INJECTABLE / INJECTION	AP	2021-02-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204842-003	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.75%	INJECTABLE / INJECTION	AP	2021-02-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204842-001	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.25%	INJECTABLE / INJECTION	AP	2021-02-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204842-002	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.5%	INJECTABLE / INJECTION	AP	2021-02-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204842-003	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.75%	INJECTABLE / INJECTION	AP	2021-02-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204842-001	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.25%	INJECTABLE / INJECTION	AP	2021-02-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204842-002	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.5%	INJECTABLE / INJECTION	AP	2021-02-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204842-003	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.75%	INJECTABLE / INJECTION	AP	2021-02-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204842-001	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.25%	INJECTABLE / INJECTION	AP	2021-02-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204842-002	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.5%	INJECTABLE / INJECTION	AP	2021-02-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204842-003	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.75%	INJECTABLE / INJECTION	AP	2021-02-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204842-001	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.25%	INJECTABLE / INJECTION	AP	2021-02-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204842-002	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.5%	INJECTABLE / INJECTION	AP	2021-02-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204842-003	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.75%	INJECTABLE / INJECTION	AP	2021-02-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204842-001	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.25%	INJECTABLE / INJECTION	AP	2021-02-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204842-002	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.5%	INJECTABLE / INJECTION	AP	2021-02-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204842-003	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.75%	INJECTABLE / INJECTION	AP	2021-02-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204842-001	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.25%	INJECTABLE / INJECTION	AP	2021-02-11	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 105 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	A204842-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204842-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204842-003	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204842-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204842-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204842-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204842-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204842-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204842-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204842-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204842-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204842-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204842-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204842-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204842-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204842-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204842-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204842-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204842-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204842-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204842-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204842-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204842-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204842-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204842-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204842-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204842-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204842-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204842-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204842-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204842-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204842-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204842-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204842-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204842-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204842-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204842-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204842-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204842-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204842-001	AP	1	`1e350fbaab3a…`

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 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
8815c8c6-eed8-4afe-a5c1-44d2194025a3	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
0143-9331-01	Bupivacaine Hydrochloride	10 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	10		4
0143-9331-10	Bupivacaine Hydrochloride	10 in 1 CARTON	INJECTION, SOLUTION	10		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0143-9331-01	ML - Milliliter	0143-9331	7d1b94ee-c044-4c87-8af6-84aa14877d15	1	2021-11-09
0143-9331-10	ML - Milliliter	0143-9331	b358b97c-0a01-4307-8e47-07f60a252285	1	2021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0143-9331	BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.]	4	Current NDC, Legacy NDC, 2 package rows	20240413_8815c8c6-eed8-4afe-a5c1-44d2194025a3.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	Hikma Pharmaceuticals USA Inc.	8815c8c6-eed8-4afe-a5c1-44d2194025a3	2024-04-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204842 application number: ANDA204842 ndc (product): 0143-9331
Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	Asclemed USA, Inc.	f37a19ad-5e69-44a8-947b-847df2106fb3	2023-08-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204842 application number: ANDA204842

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	8815c8c6-eed8-4afe-a5c1-44d2194025a3	4
1725082	BUPivacaine HCl 0.25 % in 30 ML Injection	PSN	8815c8c6-eed8-4afe-a5c1-44d2194025a3	4
1724880	BUPivacaine HCl 0.5 % in 10 ML Injection	PSN	8815c8c6-eed8-4afe-a5c1-44d2194025a3	4
1724884	BUPivacaine HCl 0.5 % in 30 ML Injection	PSN	8815c8c6-eed8-4afe-a5c1-44d2194025a3	4
1724787	BUPivacaine HCl 0.75 % in 10 ML Injection	PSN	8815c8c6-eed8-4afe-a5c1-44d2194025a3	4
1724786	BUPivacaine HCl 0.75 % in 30 ML Injection	PSN	8815c8c6-eed8-4afe-a5c1-44d2194025a3	4
1725078	10 ML bupivacaine hydrochloride 2.5 MG/ML Injection	SCD	8815c8c6-eed8-4afe-a5c1-44d2194025a3	4
1724880	10 ML bupivacaine hydrochloride 5 MG/ML Injection	SCD	8815c8c6-eed8-4afe-a5c1-44d2194025a3	4
1724787	10 ML bupivacaine hydrochloride 7.5 MG/ML Injection	SCD	8815c8c6-eed8-4afe-a5c1-44d2194025a3	4
1725082	30 ML bupivacaine hydrochloride 2.5 MG/ML Injection	SCD	8815c8c6-eed8-4afe-a5c1-44d2194025a3	4
1724884	30 ML bupivacaine hydrochloride 5 MG/ML Injection	SCD	8815c8c6-eed8-4afe-a5c1-44d2194025a3	4
1724786	30 ML bupivacaine hydrochloride 7.5 MG/ML Injection	SCD	8815c8c6-eed8-4afe-a5c1-44d2194025a3	4
1725078	bupivacaine HCl 0.25 % in 10 ML Injection	SY	8815c8c6-eed8-4afe-a5c1-44d2194025a3	4
1725082	bupivacaine HCl 0.25 % per 30 ML Injection	SY	8815c8c6-eed8-4afe-a5c1-44d2194025a3	4
1724880	bupivacaine HCl 0.5 % in 10 ML Injection	SY	8815c8c6-eed8-4afe-a5c1-44d2194025a3	4
1724884	bupivacaine HCl 0.5 % in 30 ML Injection	SY	8815c8c6-eed8-4afe-a5c1-44d2194025a3	4
1724787	bupivacaine HCl 0.75 % in 10 ML Injection	SY	8815c8c6-eed8-4afe-a5c1-44d2194025a3	4
1724786	bupivacaine HCl 0.75 % in 30 ML Injection	SY	8815c8c6-eed8-4afe-a5c1-44d2194025a3	4
1724786	bupivacaine HCl 225 MG per 30 ML Injection	SY	8815c8c6-eed8-4afe-a5c1-44d2194025a3	4
1724787	bupivacaine HCl 75 MG per 10 ML Injection	SY	8815c8c6-eed8-4afe-a5c1-44d2194025a3	4
1724880	BUPivacaine HCl 0.5 % in 10 ML Injection	PSN	f37a19ad-5e69-44a8-947b-847df2106fb3	1
1724880	10 ML bupivacaine hydrochloride 5 MG/ML Injection	SCD	f37a19ad-5e69-44a8-947b-847df2106fb3	1
1724880	bupivacaine HCl 0.5 % in 10 ML Injection	SY	f37a19ad-5e69-44a8-947b-847df2106fb3	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0143-9331-01	00143933101	10 mL in 1 VIAL, SINGLE-DOSE	10 ml					Historical
0143-9331-10	00143933110	10 VIAL, SINGLE-DOSE in 1 CARTON (0143-9331-10) / 10 mL in 1 VIAL, SINGLE-DOSE (0143-9331-01)		2021-02-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Bupivacaine Hydrochloride	Hikma Pharmaceuticals USA Inc.	2024-04-11	HUMAN PRESCRIPTION DRUG LABEL	4
Bupivacaine Hydrochloride	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2023-08-10	HUMAN PRESCRIPTION DRUG LABEL	1