BUPIVACAINE HCI

Product NDC
51662-1581
11-digit product format
516621581
Labeler code
51662
Product ID
51662-1581_0f90b497-04bc-5195-e063-6294a90a2b58
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUPIVACAINE HCI
Dosage form
INJECTION, SOLUTION
Route
INFILTRATION; PERINEURAL
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
ANDA207183
Marketing category
ANDA
Marketing start
2022-07-10
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
7TQO7W3VT8BUPIVACAINE HYDROCHLORIDE73360-54-0BUPIVACAINE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51662-1581-35166215810325 POUCH in 1 CASE (51662-1581-3) / 1 VIAL, MULTI-DOSE in 1 POUCH (51662-1581-2) / 50 mL in 1 VIAL, MULTI-DOSE25 pouch2022-07-10NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
0.25% BUPIVACAINE HCI INJECTION, USP 125mg PER 50mL (2.5 mg/mL)HF Acquisition Co LLC, DBA HealthFirst2024-01-22HUMAN PRESCRIPTION DRUG LABEL2