FDA.reportPublic FDA data

Bupivacaine Hydrochloride

Product NDC
83854-004
11-digit product format
838540004
Labeler code
83854
Product ID
83854-004_501c3ffc-2293-e956-e063-6394a90ae870
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupivacaine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL
Labeler
Anthea Pharma Private Limited
Application
ANDA220493
Marketing category
ANDA
Marketing start
2026-04-22
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7TQO7W3VT8
Rxcui1012404, 1724786, 1725078

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
83854-004-01Bupivacaine Hydrochloride10 mL in 1 VIALINJECTION, SOLUTION105
83854-004-10Bupivacaine 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
83854-004-018385400040110 mL in 1 VIAL10 mlHistorical
83854-004-108385400041010 VIAL in 1 CARTON (83854-004-10) / 10 mL in 1 VIAL (83854-004-01) 10 vial2026-04-22NoNoHistorical