Bupivacaine Hydrochloride

Product NDC: 59923-717
Requested package NDC: 59923-717-05
11-digit product format: 599230717
Labeler code: 59923
Product ID: 59923-717_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: 3 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#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	59923-717	59923-717-05	I	Inactivated by FDA		2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 15 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	59923-717	59923-717-05	I	Inactivated by FDA	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	59923-717	59923-717-05	I	Inactivated by FDA	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	59923-717	59923-717-05	I	Inactivated by FDA	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	59923-717	59923-717-05	I	Inactivated by FDA	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	59923-717	59923-717-05	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	59923-717	59923-717-05	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	59923-717	59923-717-05	I	Inactivated by FDA	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	59923-717	59923-717-05	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	59923-717	59923-717-05	I	Inactivated by FDA	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	59923-717	59923-717-05	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	59923-717	59923-717-05	I	Inactivated by FDA	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	59923-717	59923-717-05	I	Inactivated by FDA	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	59923-717	59923-717-05	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	59923-717	59923-717-05	I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	59923-717	59923-717-05	I	Inactivated by FDA	excluded / ndc_excluded.zip	`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
59923-717-05	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
59923-717-05	Bupivacaine Hydrochloride	5 mL in 1 AMPULE	INJECTION	5		2
59923-717-05	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
59923-717-05	ML - Milliliter	59923-717	6d0c17c3-ace0-4d4f-a7f8-eca6422959f2	1	2019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59923-717	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
59923-717-05	59923071705	10 AMPULE in 1 CARTON (59923-717-05) > 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