Bupivacaine Hydrochloride

Product NDC: 59923-718
11-digit product format: 599230718
Labeler code: 59923
Product ID: 59923-718_b8e455c5-46b7-1827-e053-2a95a90ae2d7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Bupivacaine Hydrochloride
Dosage form: INJECTION
Route: EPIDURAL; INTRACAUDAL; PERINEURAL
Labeler: Areva Pharmaceuticals
Marketing category: UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE
Marketing start: 2019-07-12
Marketing end: 0000-00-00
Substance: BUPIVACAINE HYDROCHLORIDE ANHYDROUS
Active strength: 5 mg/mL
Pharmacologic classes: Amide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	59923-718		I	Inactivated by FDA		2026-08-17
excluded package	package	59923-718	59923-718-05	I	Inactivated by FDA		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 30 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	59923-718-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	59923-718-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	59923-718-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	59923-718-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	59923-718-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	59923-718-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	59923-718-05	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	59923-718-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	59923-718-05	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	59923-718-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	59923-718-05	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	59923-718-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	59923-718-05	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	59923-718-05	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	59923-718-05	`1332a3947898…`	`d4bfe170f9cd…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
59923-718-05	2023-01-30	C162847	48780-1	f386c649-c80a-0266-e053-dadaa90a7c1a	Bupivacaine Hydrochloride Injection

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59923-718-05	Bupivacaine Hydrochloride	5 mL in 1 AMPULE	INJECTION	5		2
59923-718-05	Bupivacaine Hydrochloride	10 in 1 CARTON	INJECTION	10		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59923-718-05	ML - Milliliter	59923-718	5a313cb7-67b0-41e2-9b1c-62ad0b716876	1	2019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59923-718	BUPIVACAINE HYDROCHLORIDE INJECTION [AREVA PHARMACEUTICALS]	2	Legacy NDC, 2 package rows	20210115_8c168503-9120-20ea-e053-2a95a90a8bf2.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
AKA908P8J1	BUPIVACAINE HYDROCHLORIDE ANHYDROUS	18010-40-7	BUPIVACAINE HYDROCHLORIDE ANHYDROUS
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	8c168503-9120-20ea-e053-2a95a90a8bf2	2
2178759	BUPivacaine HCl 0.25 % in 5 ML Injection	PSN	8c168503-9120-20ea-e053-2a95a90a8bf2	2
1724880	BUPivacaine HCl 0.5 % in 10 ML Injection	PSN	8c168503-9120-20ea-e053-2a95a90a8bf2	2
2178760	BUPivacaine HCl 0.5 % in 5 ML Injection	PSN	8c168503-9120-20ea-e053-2a95a90a8bf2	2
1725078	10 ML bupivacaine hydrochloride 2.5 MG/ML Injection	SCD	8c168503-9120-20ea-e053-2a95a90a8bf2	2
1724880	10 ML bupivacaine hydrochloride 5 MG/ML Injection	SCD	8c168503-9120-20ea-e053-2a95a90a8bf2	2
2178759	5 ML bupivacaine hydrochloride 2.5 MG/ML Injection	SCD	8c168503-9120-20ea-e053-2a95a90a8bf2	2
2178760	5 ML bupivacaine hydrochloride 5 MG/ML Injection	SCD	8c168503-9120-20ea-e053-2a95a90a8bf2	2
1725078	bupivacaine HCl 0.25 % in 10 ML Injection	SY	8c168503-9120-20ea-e053-2a95a90a8bf2	2
2178759	bupivacaine HCl 0.25 % in 5 ML Injection	SY	8c168503-9120-20ea-e053-2a95a90a8bf2	2
1724880	bupivacaine HCl 0.5 % in 10 ML Injection	SY	8c168503-9120-20ea-e053-2a95a90a8bf2	2
2178760	bupivacaine HCl 0.5 % in 5 ML Injection	SY	8c168503-9120-20ea-e053-2a95a90a8bf2	2
2178759	bupivacaine HCl 12.5 MG per 5 ML Injection	SY	8c168503-9120-20ea-e053-2a95a90a8bf2	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59923-718-05	59923071805	10 AMPULE in 1 CARTON (59923-718-05) > 5 mL in 1 AMPULE	10 ampule	2019-07-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Bupivacaine Hydrochloride Injection	Areva Pharmaceuticals \| Fisiopharma SRL	2021-01-14	HUMAN PRESCRIPTION DRUG LABEL	2