FDA.reportPublic FDA data

Bupivacaine Hydrochloride

Product NDC
52584-160
11-digit product format
525840160
Labeler code
52584
Product ID
52584-160_3dbb9b88-8e63-4bd3-818e-0b2751337283
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupivacaine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INFILTRATION; PERINEURAL
Labeler
General Injectables & Vaccines, Inc
Application
ANDA070590
Marketing category
ANDA
Marketing start
2010-07-01
Marketing end
2024-02-01
Substance
BUPIVACAINE HYDROCHLORIDE
Active strength
3 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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct52584-160DDiscontinued by firm2026-07-31
excluded packagepackage52584-16052584-160-01DDiscontinued by firm2026-07-31

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A070590-001BUPIVACAINE HYDROCHLORIDEBUPIVACAINE HYDROCHLORIDE0.25%INJECTABLE / INJECTIONAP1987-02-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A070590-001AP

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A070590-001BUPIVACAINE HYDROCHLORIDE0.25%INJECTABLE / INJECTIONAP1987-02-17a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A070590-001AP1a50c72e98297…

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEHospira, Inc.02a845c3-4521-4926-e397-25ab536e7cf62026-03-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070590
application number: ANDA070590
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEHenry Schein, Inc3c0f567f-b7f8-4ee8-bfb2-61cd825504982025-10-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070590
application number: ANDA070590
BUPIVACAINE HYDROCHLORIDEBUPIVACAINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst950d82b6-76a1-0c08-e053-2a95a90a3a922024-06-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070590
application number: ANDA070590
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEMedical Purchasing Solutions, LLCada6a9bf-f7cb-035a-e053-2a95a90a6a3d2023-05-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070590
application number: ANDA070590

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Bupivacaine HydrochlorideACTIVE INGREDIENT7TQO7W3VT8BUPIVACAINE HYDROCHLORIDE INJECTION [GENERAL INJECTABLES & VACCINES, INC]2
BupivacaineACTIVE MOIETYY8335394ROBUPIVACAINE HYDROCHLORIDE INJECTION [GENERAL INJECTABLES & VACCINES, INC]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
52584-160-01525840160011 VIAL, MULTI-DOSE in 1 BAG (52584-160-01) > 50 mL in 1 VIAL, MULTI-DOSE2016-09-090000-00-00NoNoCurrent