FDA.reportPublic FDA data

Bupivacaine Hydrochloride

Product NDC
71351-022
11-digit product format
713510022
Labeler code
71351
Product ID
71351-022_484033d6-ca7d-f0fd-e063-6294a90a7890
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupivacaine hydrochloride
Dosage form
INJECTION
Route
SUBARACHNOID
Labeler
Brookfield Pharmaceuticals, LLC.
Application
ANDA212822
Marketing category
ANDA
Marketing start
2022-10-31
Substance
BUPIVACAINE HYDROCHLORIDE
Active strength
7.5 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 HYDROCHLORIDE7.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7TQO7W3VT8
Rxcui1724784

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
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71351-022-02Bupivacaine Hydrochloride2 mL in 1 AMPULEINJECTION26
71351-022-10Bupivacaine Hydrochloride10 in 1 PACKAGEINJECTION106
71351-022-50Bupivacaine Hydrochloride50 in 1 PACKAGEINJECTION506

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71351-022-02ML - Milliliter71351-0220ef2a5f0-36ff-41b6-8d0e-eb4a21c6114912023-03-13
71351-022-10ML - Milliliter71351-0228b364bba-f071-4b42-bee7-9826834045e412023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71351-022BUPIVACAINE HYDROCHLORIDE INJECTION [BROOKFIELD PHARMACEUTICALS, LLC.]4Current NDC, Legacy NDC, 3 package rows20241224_e8b32972-6984-4f1c-e053-2995a90a3277.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1724784BUPivacaine HCl 0.75 % in 2 ML InjectionPSNe8b32972-6984-4f1c-e053-2995a90a32776
17247842 ML bupivacaine hydrochloride 7.5 MG/ML InjectionSCDe8b32972-6984-4f1c-e053-2995a90a32776
1724784bupivacaine HCl 0.75 % per 2 ML InjectionSYe8b32972-6984-4f1c-e053-2995a90a32776
1724784bupivacaine HCl 15 MG per 2 ML InjectionSYe8b32972-6984-4f1c-e053-2995a90a32776

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71351-022-02713510022022 mL in 1 AMPULE2 mlHistorical
71351-022-107135100221010 AMPULE in 1 PACKAGE (71351-022-10) / 2 mL in 1 AMPULE (71351-022-02) 10 ampule2023-02-23NoNoCurrent
71351-022-507135100225050 AMPULE in 1 PACKAGE (71351-022-50) / 2 mL in 1 AMPULE (71351-022-02) 50 ampule2022-10-310000-00-00NoNoCurrent