SENSORCAINE(R) (BUPIVACAINE HCI AND EPINEPHRINE)

Product NDC
51662-1397
11-digit product format
516621397
Labeler code
51662
Product ID
51662-1397_1032a94b-35f3-8839-e063-6394a90a5f7b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SENSORCAINE(R) (BUPIVACAINE HCI AND EPINEPHRINE)
Dosage form
INJECTION, SOLUTION
Route
INFILTRATION; PERINEURAL
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
ANDA070967
Marketing category
ANDA
Marketing start
2019-10-08
Substance
BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
Active strength
2.5; .005 mg/mL; mg/mL
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]
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
30Q7KI53AKEPINEPHRINE BITARTRATE51-42-3EPINEPHRINE BITARTRATE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51662-1397-15166213970150 mL in 1 VIAL, MULTI-DOSE (51662-1397-1) 50 ml2019-10-08NoNoHistorical
51662-1397-2516621397021 VIAL, MULTI-DOSE in 1 POUCH (51662-1397-2) / 50 mL in 1 VIAL, MULTI-DOSE2021-01-26NoNoHistorical
51662-1397-35166213970325 POUCH in 1 CASE (51662-1397-3) / 1 VIAL, MULTI-DOSE in 1 POUCH / 50 mL in 1 VIAL, MULTI-DOSE25 pouch2021-01-26NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
SENSORCAINE(R) (BUPIVACAINE HCI AND EPINEPHRINE)HF Acquisition Co LLC, DBA HealthFirst2024-01-30HUMAN PRESCRIPTION DRUG LABEL4