FDA.reportPublic FDA data

bupivacaine hydrochloride

Product NDC
71288-725
11-digit product format
712880725
Labeler code
71288
Product ID
71288-725_05aa974a-bfed-44d5-9dba-0427a76ff70b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupivacaine hydrochloride
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL; INTRACAUDAL; PERINEURAL
Labeler
Meitheal Pharmaceuticals Inc
Application
ANDA216040
Marketing category
ANDA
Marketing start
2023-12-27
Marketing end
2026-07-21
Substance
BUPIVACAINE HYDROCHLORIDE
Active strength
5 mg/mL
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
bupivacaine hydrochloride

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPIVACAINE HYDROCHLORIDE5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7TQO7W3VT8
Rxcui1724786, 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
71288-725-32bupivacaine hydrochloride1 in 1 CARTONINJECTION, SOLUTION12
71288-725-32bupivacaine hydrochloride30 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-725-32ML - Milliliter71288-725981c5032-b4c2-446d-ba02-ba202a6131ac12024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-725BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [MEITHEAL PHARMACEUTICALS INC]1Current NDC, 2 package rows20240130_daec9ee4-b666-485e-a153-4b5e5acc48a1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1725078BUPivacaine HCl 0.25 % in 10 ML InjectionPSNdaec9ee4-b666-485e-a153-4b5e5acc48a12
1725082BUPivacaine HCl 0.25 % in 30 ML InjectionPSNdaec9ee4-b666-485e-a153-4b5e5acc48a12
1724880BUPivacaine HCl 0.5 % in 10 ML InjectionPSNdaec9ee4-b666-485e-a153-4b5e5acc48a12
1724884BUPivacaine HCl 0.5 % in 30 ML InjectionPSNdaec9ee4-b666-485e-a153-4b5e5acc48a12
1724787BUPivacaine HCl 0.75 % in 10 ML InjectionPSNdaec9ee4-b666-485e-a153-4b5e5acc48a12
1724786BUPivacaine HCl 0.75 % in 30 ML InjectionPSNdaec9ee4-b666-485e-a153-4b5e5acc48a12
172507810 ML bupivacaine hydrochloride 2.5 MG/ML InjectionSCDdaec9ee4-b666-485e-a153-4b5e5acc48a12
172488010 ML bupivacaine hydrochloride 5 MG/ML InjectionSCDdaec9ee4-b666-485e-a153-4b5e5acc48a12
172478710 ML bupivacaine hydrochloride 7.5 MG/ML InjectionSCDdaec9ee4-b666-485e-a153-4b5e5acc48a12
172508230 ML bupivacaine hydrochloride 2.5 MG/ML InjectionSCDdaec9ee4-b666-485e-a153-4b5e5acc48a12
172488430 ML bupivacaine hydrochloride 5 MG/ML InjectionSCDdaec9ee4-b666-485e-a153-4b5e5acc48a12
172478630 ML bupivacaine hydrochloride 7.5 MG/ML InjectionSCDdaec9ee4-b666-485e-a153-4b5e5acc48a12
1725078bupivacaine HCl 0.25 % in 10 ML InjectionSYdaec9ee4-b666-485e-a153-4b5e5acc48a12
1725082bupivacaine HCl 0.25 % per 30 ML InjectionSYdaec9ee4-b666-485e-a153-4b5e5acc48a12
1724880bupivacaine HCl 0.5 % in 10 ML InjectionSYdaec9ee4-b666-485e-a153-4b5e5acc48a12
1724884bupivacaine HCl 0.5 % in 30 ML InjectionSYdaec9ee4-b666-485e-a153-4b5e5acc48a12
1724787bupivacaine HCl 0.75 % in 10 ML InjectionSYdaec9ee4-b666-485e-a153-4b5e5acc48a12
1724786bupivacaine HCl 0.75 % in 30 ML InjectionSYdaec9ee4-b666-485e-a153-4b5e5acc48a12
1724786bupivacaine HCl 225 MG per 30 ML InjectionSYdaec9ee4-b666-485e-a153-4b5e5acc48a12
1724787bupivacaine HCl 75 MG per 10 ML InjectionSYdaec9ee4-b666-485e-a153-4b5e5acc48a12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71288-725-32712880725321 VIAL, SINGLE-DOSE in 1 CARTON (71288-725-32) / 30 mL in 1 VIAL, SINGLE-DOSE2023-12-272026-07-01NoNoHistorical