FDA.reportPublic FDA data

Bupivacaine Hydrochloride

Product NDC
55150-250
11-digit product format
551500250
Labeler code
55150
Product ID
55150-250_39649703-e633-4a20-ba71-0c04dbf8ff2a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupivacaine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
PERINEURAL
Labeler
Eugia US LLC
Application
ANDA207183
Marketing category
ANDA
Marketing start
2016-05-13
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
1ea46721-9071-6b81-fd0a-a82bfbb014ecProduct name720250220
525701df-f985-480d-995a-e0ee70c2bdf4Product name520250128
ea50b939-d92a-4100-84f5-1c1089663837Product name220240705
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
941f67d9-7f03-56d2-750c-36de24f654dbProduct name320221117
d7d46a10-8766-d3c8-ebf2-2ccd9efdcae8Product name220220506
7b2c58e8-5850-4e3e-82e9-b1593b1de761Product name520220210
e3a99641-4540-4894-9108-00cab3c57b7eProduct name120211207
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
5da98533-f072-406b-9e1b-6ac19eca9926Product name120210622
306b993e-3140-4823-ad5e-88b708f9d2acProduct name120210510
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
a831e694-3663-4a83-82be-6c309429f750Product name220200608
81e34474-b0a5-434f-8104-25d689efc99eProduct name120200303
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
05ab9c01-cd9a-4f59-b2e8-ddcb887cac39Product name120190408
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0c7dba41-c919-5809-508d-4affe6cfcff2Product name220170817
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
399647c0-db89-02d1-991c-0c17b584482cProduct name120140508
3e9a6377-704f-dff7-b19f-56c98d40c444Product name120140508
4d2e6ff9-14f5-b84f-c39b-373b005712c1Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
725d71bf-f956-5cad-e556-fa39cb060dc8Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
9ea85abb-fa68-5da6-ab60-2c7eef579000Product name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
d029211e-5e6b-725f-3696-ac6ff77da222Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55150-250-50Bupivacaine Hydrochloride50 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION509
55150-250-50Bupivacaine Hydrochloride25 in 1 CARTONINJECTION, SOLUTION259

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55150-250-50ML - Milliliter55150-250d8117f97-6d25-4106-a667-064c9ec2658412017-10-13

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
55150-250BUPIVACAINE 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
1012404BUPivacaine HCl 0.5 % Injectable SolutionPSN1091d4d8-5dad-46e1-8f26-7bc0c5dd833f8
1012404bupivacaine hydrochloride 5 MG/ML Injectable SolutionSCD1091d4d8-5dad-46e1-8f26-7bc0c5dd833f8
1012404bupivacaine hydrochloride 0.5 % Injectable SolutionSY1091d4d8-5dad-46e1-8f26-7bc0c5dd833f8
1012404BUPivacaine HCl 0.5 % Injectable SolutionPSNd19bf48e-b64e-4fe4-82ab-12cb444e92c43
1116927dexAMETHasone sodium phosphate 4 MG/ML (dexAMETHasone phosphate equivalent) Injectable SolutionPSNd19bf48e-b64e-4fe4-82ab-12cb444e92c43
1012404bupivacaine hydrochloride 5 MG/ML Injectable SolutionSCDd19bf48e-b64e-4fe4-82ab-12cb444e92c43
1116927dexamethasone phosphate 4 MG/ML Injectable SolutionSCDd19bf48e-b64e-4fe4-82ab-12cb444e92c43
1012404bupivacaine hydrochloride 0.5 % Injectable SolutionSYd19bf48e-b64e-4fe4-82ab-12cb444e92c43
1116927dexamethasone phosphate 4 MG/ML (as dexamethasone sodium phosphate 4.4 MG/ML) Injectable SolutionSYd19bf48e-b64e-4fe4-82ab-12cb444e92c43
1012404BUPivacaine HCl 0.5 % Injectable SolutionPSNd1642239-4230-b679-e053-2a95a90a3b7c2
1012404BUPivacaine HCl 0.5 % Injectable SolutionPSN06c15208-c600-7173-e063-6394a90a2f942
1012404bupivacaine hydrochloride 5 MG/ML Injectable SolutionSCDd1642239-4230-b679-e053-2a95a90a3b7c2
1012404bupivacaine hydrochloride 5 MG/ML Injectable SolutionSCD06c15208-c600-7173-e063-6394a90a2f942
1012404bupivacaine hydrochloride 0.5 % Injectable SolutionSY06c15208-c600-7173-e063-6394a90a2f942
1012404bupivacaine hydrochloride 0.5 % Injectable SolutionSYd1642239-4230-b679-e053-2a95a90a3b7c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55150-250-505515002505025 VIAL, MULTI-DOSE in 1 CARTON (55150-250-50) / 50 mL in 1 VIAL, MULTI-DOSE2016-05-130000-00-00NoNoCurrent