FDA.reportPublic FDA data

Bupivacaine Hydrochloride

Product NDC
83854-005
11-digit product format
838540005
Labeler code
83854
Product ID
83854-005_501c3ffc-2293-e956-e063-6394a90ae870
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupivacaine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL; RETROBULBAR
Labeler
Anthea Pharma Private Limited
Application
ANDA220493
Marketing category
ANDA
Marketing start
2026-04-22
Substance
BUPIVACAINE HYDROCHLORIDE
Active strength
7.5 mg/mL
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A220493-001BUPIVACAINE HYDROCHLORIDEBUPIVACAINE HYDROCHLORIDE0.25%INJECTABLE / INJECTIONAP2026-04-22
A220493-002BUPIVACAINE HYDROCHLORIDEBUPIVACAINE HYDROCHLORIDE0.5%INJECTABLE / INJECTIONAP2026-04-22
A220493-003BUPIVACAINE HYDROCHLORIDEBUPIVACAINE HYDROCHLORIDE0.75%INJECTABLE / INJECTIONAP2026-04-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A220493-001AP
A220493-002AP
A220493-003AP

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
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220493-001BUPIVACAINE HYDROCHLORIDE0.25%INJECTABLE / INJECTIONAP2026-04-22a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220493-002BUPIVACAINE HYDROCHLORIDE0.5%INJECTABLE / INJECTIONAP2026-04-22a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220493-003BUPIVACAINE HYDROCHLORIDE0.75%INJECTABLE / INJECTIONAP2026-04-22a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220493-001AP1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220493-002AP1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220493-003AP1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Bupivacaine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPIVACAINE HYDROCHLORIDE7.5 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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1012404Internal RxNorm lookup
1724786Internal RxNorm lookup
1725078Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4e0cff98-ad0e-494d-8316-b7cdfad6a876Available 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
83854-005-01Bupivacaine Hydrochloride30 mL in 1 VIALINJECTION, SOLUTION305
83854-005-10Bupivacaine Hydrochloride10 in 1 CARTONINJECTION, SOLUTION105

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEAnthea Pharma Private Limited4e0cff98-ad0e-494d-8316-b7cdfad6a8762026-04-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 220493
application number: ANDA220493
ndc (product): 83854-005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1725078BUPivacaine HCl 0.25 % in 10 ML InjectionPSN4e0cff98-ad0e-494d-8316-b7cdfad6a8765
1012404BUPivacaine HCl 0.5 % Injectable SolutionPSN4e0cff98-ad0e-494d-8316-b7cdfad6a8765
1724786BUPivacaine HCl 0.75 % in 30 ML InjectionPSN4e0cff98-ad0e-494d-8316-b7cdfad6a8765
172507810 ML bupivacaine hydrochloride 2.5 MG/ML InjectionSCD4e0cff98-ad0e-494d-8316-b7cdfad6a8765
172478630 ML bupivacaine hydrochloride 7.5 MG/ML InjectionSCD4e0cff98-ad0e-494d-8316-b7cdfad6a8765
1012404bupivacaine hydrochloride 5 MG/ML Injectable SolutionSCD4e0cff98-ad0e-494d-8316-b7cdfad6a8765
1725078bupivacaine HCl 0.25 % in 10 ML InjectionSY4e0cff98-ad0e-494d-8316-b7cdfad6a8765
1724786bupivacaine HCl 0.75 % in 30 ML InjectionSY4e0cff98-ad0e-494d-8316-b7cdfad6a8765
1724786bupivacaine HCl 225 MG per 30 ML InjectionSY4e0cff98-ad0e-494d-8316-b7cdfad6a8765
1012404bupivacaine hydrochloride 0.5 % Injectable SolutionSY4e0cff98-ad0e-494d-8316-b7cdfad6a8765

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83854-005-018385400050130 mL in 1 VIAL30 mlHistorical
83854-005-108385400051010 VIAL in 1 CARTON (83854-005-10) / 30 mL in 1 VIAL (83854-005-01) 10 vial2026-04-22NoNoCurrent