Bupivacaine Hydrochloride

Product NDC: 52584-163
Requested package NDC: 52584-163-01
11-digit product format: 525840163
Labeler code: 52584
Product ID: 52584-163_3d03c317-10a2-48a8-952e-9c8574923ddc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Bupivacaine Hydrochloride
Dosage form: INJECTION, SOLUTION
Route: PERINEURAL
Labeler: General Injectables & Vaccines, Inc
Application: ANDA070597
Marketing category: ANDA
Marketing start: 2010-07-01
Marketing end: 2023-11-01
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: 0000-00-00
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	52584-163	52584-163-01	D	Discontinued by firm		2026-07-31

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
A070597-001	BUPIVACAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	0.5%	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
A070597-001	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	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A070597-001	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP		1987-03-03	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A070597-001	AP	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 3 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): 070597 application number: ANDA070597
Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	Henry Schein, Inc	496ccd9e-d1c3-4b5a-93b6-0c457faa1589	2025-10-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070597 application number: ANDA070597
BUPIVACAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	950d82b6-76a1-0c08-e053-2a95a90a3a92	2024-06-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070597 application number: ANDA070597

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
Bupivacaine Hydrochloride	ACTIVE INGREDIENT	7TQO7W3VT8	BUPIVACAINE HYDROCHLORIDE INJECTION [GENERAL INJECTABLES & VACCINES, INC]	3
Bupivacaine	ACTIVE MOIETY	Y8335394RO	BUPIVACAINE HYDROCHLORIDE INJECTION [GENERAL INJECTABLES & VACCINES, INC]	3

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7TQO7W3VT8	BUPIVACAINE HYDROCHLORIDE	73360-54-0	BUPIVACAINE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
52584-163-01	52584016301	1 VIAL, MULTI-DOSE in 1 BAG (52584-163-01) > 50 mL in 1 VIAL, MULTI-DOSE	2010-07-01	2023-11-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Bupivacaine HCL 0.5% 5 mg/mL Injection, USP 50 mL Multi Dose Vial	General Injectables & Vaccines, Inc	2022-12-12	HUMAN PRESCRIPTION DRUG LABEL	10