FDA.reportPublic FDA data

BUPIVICAINE HYDROCHLORIDE

Product NDC
51662-1456
11-digit product format
516621456
Labeler code
51662
Product ID
51662-1456_b107e2b0-091e-b326-e053-2a95a90aa253
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUPIVICAINE HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
ANDA070583
Marketing category
ANDA
Marketing start
2019-12-12
Substance
BUPIVACAINE HYDROCHLORIDE
Active strength
2.5 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 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
A070583-001BUPIVACAINE 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
A070583-001AP

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 22:54:322026-06A070583-001BUPIVACAINE 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 22:54:322026-06A070583-001AP1a50c72e98297…

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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDESportpharm LLC6f9ebeef-350a-495e-a0bf-c335ab48bf1c2026-04-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070583
application number: ANDA070583
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDECardinal Health 107, LLC8f8f4ece-de78-4c13-8d9f-c3bb7053019d2026-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070583
application number: ANDA070583
BUPIVACAINE HYDROCHLORIDEBUPIVACAINE HYDROCHLORIDEHospira, Inc.bb44c7e1-d911-4788-908f-09b7b271969b2026-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070583
application number: ANDA070583
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEHospira, Inc.02a845c3-4521-4926-e397-25ab536e7cf62026-03-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070583
application number: ANDA070583
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEProPharma Distribution3f7ab295-6429-4760-e063-6294a90a781f2025-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070583
application number: ANDA070583
BUPIVICAINE HYDROCHLORIDEBUPIVICAINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst99857946-6084-1bbd-e053-2a95a90af58c2020-10-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070583
application number: ANDA070583
ndc (product): 51662-1456

Additional Listing Data#

Finished product
Yes
Brand name base
BUPIVICAINE HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPIVACAINE HYDROCHLORIDE2.5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7TQO7W3VT8Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
99857946-6084-1bbd-e053-2a95a90af58cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cbf85893-59ef-423f-87d4-a573c000a8b9Product name820250731
5dad6767-dcd1-b0da-8727-7f3f7bc3a435Product name220250303
e3a99641-4540-4894-9108-00cab3c57b7eProduct name120211207
5da98533-f072-406b-9e1b-6ac19eca9926Product name120210622
306b993e-3140-4823-ad5e-88b708f9d2acProduct name120210510
a831e694-3663-4a83-82be-6c309429f750Product name220200608

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51662-1456-1BUPIVICAINE HYDROCHLORIDE30 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1456BUPIVICAINE HYDROCHLORIDE INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]3Current NDC, Legacy NDC, 1 package rows20201007_99857946-6084-1bbd-e053-2a95a90af58c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1456-15166214560130 mL in 1 VIAL, SINGLE-DOSE (51662-1456-1) 30 ml2019-12-120000-00-00NoNoCurrent