FDA.reportPublic FDA data

Bupivacaine Hydrochloride

Product NDC
55150-249
11-digit product format
551500249
Labeler code
55150
Product ID
55150-249_39649703-e633-4a20-ba71-0c04dbf8ff2a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupivacaine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INFILTRATION; PERINEURAL
Labeler
Eugia US LLC
Application
ANDA207183
Marketing category
ANDA
Marketing start
2016-05-13
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
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 HYDROCHLORIDE2.5 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
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bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
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5dad6767-dcd1-b0da-8727-7f3f7bc3a435Product name220250303
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
69b49899-11cf-4f7e-bd0a-7dc93b27311bProduct name320250130
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
bbdc14c7-d940-43b5-a2f7-36c425991f3cProduct name120240320
0a2fcc35-464b-9ec2-a622-753662cdd48cProduct name320240216
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6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
1dbefad7-ab34-69c3-e51a-e7148aa38f70Product name520220921
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7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
306b993e-3140-4823-ad5e-88b708f9d2acProduct name120210510
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aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
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290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
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1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
4f07db9b-3707-3e2c-05b5-d7852ba808c4Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
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810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
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9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508
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c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55150-249-50Bupivacaine Hydrochloride25 in 1 CARTONINJECTION, SOLUTION259
55150-249-50Bupivacaine Hydrochloride50 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION509

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55150-249-50ML - Milliliter55150-2490d9ff9f3-b413-4b8f-b7d6-f2b591f4c1b512017-10-13

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
55150-249BUPIVACAINE 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
1012396BUPivacaine HCl 0.25 % Injectable SolutionPSN694926ac-aff0-aa1f-e053-2991aa0a95884
1012396bupivacaine hydrochloride 2.5 MG/ML Injectable SolutionSCD694926ac-aff0-aa1f-e053-2991aa0a95884
1012396bupivacaine hydrochloride 0.25 % Injectable SolutionSY694926ac-aff0-aa1f-e053-2991aa0a95884
578803betamethasone sodium phosphate / betamethasone acetate 6 MG/ML Injectable SuspensionPSN10977293-48df-4bd6-bf38-e4496d8b64433
1012396BUPivacaine HCl 0.25 % Injectable SolutionPSN10977293-48df-4bd6-bf38-e4496d8b64433
797544isopropyl alcohol 70 % Medicated PadPSN10977293-48df-4bd6-bf38-e4496d8b64433
1010671lidocaine HCl 2 % Injectable SolutionPSN10977293-48df-4bd6-bf38-e4496d8b64433
578803betamethasone 3 MG/ML / betamethasone acetate 3 MG/ML Injectable SuspensionSCD10977293-48df-4bd6-bf38-e4496d8b64433
1012396bupivacaine hydrochloride 2.5 MG/ML Injectable SolutionSCD10977293-48df-4bd6-bf38-e4496d8b64433
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD10977293-48df-4bd6-bf38-e4496d8b64433
1010671lidocaine hydrochloride 20 MG/ML Injectable SolutionSCD10977293-48df-4bd6-bf38-e4496d8b64433
578803betamethasone 3 MG/ML (as betamethasone sodium phosphate) / betamethasone acetate 3 MG/ML Injectable SuspensionSY10977293-48df-4bd6-bf38-e4496d8b64433
1012396bupivacaine hydrochloride 0.25 % Injectable SolutionSY10977293-48df-4bd6-bf38-e4496d8b64433
797544isopropyl alcohol 70 % Medicated PadSY10977293-48df-4bd6-bf38-e4496d8b64433
797544isopropyl alcohol 70 % Topical ClothSY10977293-48df-4bd6-bf38-e4496d8b64433
797544isopropyl alcohol 70 % Topical SwabSY10977293-48df-4bd6-bf38-e4496d8b64433
1010671lidocaine hydrochloride 2 % Injectable SolutionSY10977293-48df-4bd6-bf38-e4496d8b64433
1012396BUPivacaine HCl 0.25 % Injectable SolutionPSNe37e1599-db88-2fcd-e053-2995a90a00e52
1012396bupivacaine hydrochloride 2.5 MG/ML Injectable SolutionSCDe37e1599-db88-2fcd-e053-2995a90a00e52
1012396bupivacaine hydrochloride 0.25 % Injectable SolutionSYe37e1599-db88-2fcd-e053-2995a90a00e52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55150-249-505515002495025 VIAL, MULTI-DOSE in 1 CARTON (55150-249-50) / 50 mL in 1 VIAL, MULTI-DOSE2016-05-130000-00-00NoNoCurrent