FDA.reportPublic FDA data

Bupivacaine Hydrochloride

Product NDC
55150-169
11-digit product format
551500169
Labeler code
55150
Product ID
55150-169_39649703-e633-4a20-ba71-0c04dbf8ff2a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupivacaine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL; INTRACAUDAL
Labeler
Eugia US LLC
Application
ANDA203895
Marketing category
ANDA
Marketing start
2013-11-05
Substance
BUPIVACAINE HYDROCHLORIDE
Active strength
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

Additional Listing Data#

Finished product
Yes
Brand name base
Bupivacaine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPIVACAINE HYDROCHLORIDE5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7TQO7W3VT8
Rxcui1012396, 1012404, 1724786, 1724787, 1724880, 1724884, 1725078, 1725082

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
55150-169-10Bupivacaine Hydrochloride10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION109
55150-169-10Bupivacaine Hydrochloride25 in 1 CARTONINJECTION, SOLUTION259

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55150-169-10ML - Milliliter55150-169d92dcf1e-4e25-440f-a7ae-2e456d6717ed12014-01-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUPIVACAINE HYDROCHLORIDEACTIVE INGREDIENT7TQO7W3VT8BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [AUROMEDICS PHARMA LLC]3
BUPIVACAINEACTIVE MOIETYY8335394ROBUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [AUROMEDICS PHARMA LLC]3
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBBUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [AUROMEDICS PHARMA LLC]3
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XBUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [AUROMEDICS PHARMA LLC]3
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IBUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [AUROMEDICS PHARMA LLC]3
WATERINACTIVE INGREDIENT059QF0KO0RBUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [AUROMEDICS PHARMA LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-169BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [EUGIA US LLC]9Current NDC, Legacy NDC, 2 package rows20250516_ffecf450-1f01-4721-8e10-251385852612.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1725078BUPivacaine HCl 0.25 % in 10 ML InjectionPSNffecf450-1f01-4721-8e10-2513858526129
1725082BUPivacaine HCl 0.25 % in 30 ML InjectionPSNffecf450-1f01-4721-8e10-2513858526129
1012396BUPivacaine HCl 0.25 % Injectable SolutionPSNffecf450-1f01-4721-8e10-2513858526129
1724880BUPivacaine HCl 0.5 % in 10 ML InjectionPSNffecf450-1f01-4721-8e10-2513858526129
1724884BUPivacaine HCl 0.5 % in 30 ML InjectionPSNffecf450-1f01-4721-8e10-2513858526129
1012404BUPivacaine HCl 0.5 % Injectable SolutionPSNffecf450-1f01-4721-8e10-2513858526129
1724787BUPivacaine HCl 0.75 % in 10 ML InjectionPSNffecf450-1f01-4721-8e10-2513858526129
1724786BUPivacaine HCl 0.75 % in 30 ML InjectionPSNffecf450-1f01-4721-8e10-2513858526129
172507810 ML bupivacaine hydrochloride 2.5 MG/ML InjectionSCDffecf450-1f01-4721-8e10-2513858526129
172488010 ML bupivacaine hydrochloride 5 MG/ML InjectionSCDffecf450-1f01-4721-8e10-2513858526129
172478710 ML bupivacaine hydrochloride 7.5 MG/ML InjectionSCDffecf450-1f01-4721-8e10-2513858526129
172508230 ML bupivacaine hydrochloride 2.5 MG/ML InjectionSCDffecf450-1f01-4721-8e10-2513858526129
172488430 ML bupivacaine hydrochloride 5 MG/ML InjectionSCDffecf450-1f01-4721-8e10-2513858526129
172478630 ML bupivacaine hydrochloride 7.5 MG/ML InjectionSCDffecf450-1f01-4721-8e10-2513858526129
1012396bupivacaine hydrochloride 2.5 MG/ML Injectable SolutionSCDffecf450-1f01-4721-8e10-2513858526129
1012404bupivacaine hydrochloride 5 MG/ML Injectable SolutionSCDffecf450-1f01-4721-8e10-2513858526129
1725078bupivacaine HCl 0.25 % in 10 ML InjectionSYffecf450-1f01-4721-8e10-2513858526129
1725082bupivacaine HCl 0.25 % per 30 ML InjectionSYffecf450-1f01-4721-8e10-2513858526129
1724880bupivacaine HCl 0.5 % in 10 ML InjectionSYffecf450-1f01-4721-8e10-2513858526129
1724884bupivacaine HCl 0.5 % in 30 ML InjectionSYffecf450-1f01-4721-8e10-2513858526129
1724787bupivacaine HCl 0.75 % in 10 ML InjectionSYffecf450-1f01-4721-8e10-2513858526129
1724786bupivacaine HCl 0.75 % in 30 ML InjectionSYffecf450-1f01-4721-8e10-2513858526129
1724786bupivacaine HCl 225 MG per 30 ML InjectionSYffecf450-1f01-4721-8e10-2513858526129
1724787bupivacaine HCl 75 MG per 10 ML InjectionSYffecf450-1f01-4721-8e10-2513858526129
1012396bupivacaine hydrochloride 0.25 % Injectable SolutionSYffecf450-1f01-4721-8e10-2513858526129
1012404bupivacaine hydrochloride 0.5 % Injectable SolutionSYffecf450-1f01-4721-8e10-2513858526129
1724880BUPivacaine HCl 0.5 % in 10 ML InjectionPSNa60303c2-5217-41db-855b-83fa2a749da22
172488010 ML bupivacaine hydrochloride 5 MG/ML InjectionSCDa60303c2-5217-41db-855b-83fa2a749da22
1724880bupivacaine HCl 0.5 % in 10 ML InjectionSYa60303c2-5217-41db-855b-83fa2a749da22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55150-169-105515001691025 VIAL, SINGLE-DOSE in 1 CARTON (55150-169-10) / 10 mL in 1 VIAL, SINGLE-DOSE2013-11-050000-00-00NoNoCurrent