FDA.reportPublic FDA data

Bupivacaine Hydrochloride

Product NDC
83854-005
Requested package NDC
83854-005-11
11-digit product format
838540005
Labeler code
83854
Product ID
83854-005_5c9994dc-1543-ade0-e063-6294a90ae211
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 43.

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
2026-09-14 22:38:342026-08A220493-001BUPIVACAINE HYDROCHLORIDE0.25%INJECTABLE / INJECTIONAP2026-04-2284e616aacf4f…
2026-09-14 22:38:342026-08A220493-002BUPIVACAINE HYDROCHLORIDE0.5%INJECTABLE / INJECTIONAP2026-04-2284e616aacf4f…
2026-09-14 22:38:342026-08A220493-003BUPIVACAINE HYDROCHLORIDE0.75%INJECTABLE / INJECTIONAP2026-04-2284e616aacf4f…
2026-08-18 06:07:402026-07A220493-001BUPIVACAINE HYDROCHLORIDE0.25%INJECTABLE / INJECTIONAP2026-04-22caaa826d4ba7…
2026-08-18 06:07:402026-07A220493-002BUPIVACAINE HYDROCHLORIDE0.5%INJECTABLE / INJECTIONAP2026-04-22caaa826d4ba7…
2026-08-18 06:07:402026-07A220493-003BUPIVACAINE HYDROCHLORIDE0.75%INJECTABLE / INJECTIONAP2026-04-22caaa826d4ba7…
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
2026-09-14 22:38:342026-08A220493-001AP184e616aacf4f…
2026-09-14 22:38:342026-08A220493-002AP184e616aacf4f…
2026-09-14 22:38:342026-08A220493-003AP184e616aacf4f…
2026-08-18 06:07:402026-07A220493-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A220493-002AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A220493-003AP1caaa826d4ba7…
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…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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

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

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
83854-005-118385400051110 VIAL in 1 CARTON (83854-005-11) / 10 mL in 1 VIAL (83854-005-02) 10 vial2026-09-11NoNoCurrent