LIDOCAINE AND PRILOCAINE

Product NDC
68071-3856
11-digit product format
680713856
Labeler code
68071
Product ID
68071-3856_365e4b50-2df9-1a48-e063-6294a90a69f2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine and Prilocaine
Dosage form
CREAM
Route
TOPICAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA212482
Marketing category
ANDA
Marketing start
2022-12-20
Substance
LIDOCAINE; PRILOCAINE
Active strength
25; 25 mg/g; mg/g
Pharmacologic classes
Amide Local Anesthetic [EPC], Amide Local Anesthetic [EPC], Amides [CS], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE], 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
98PI200987LIDOCAINE137-58-6LIDOCAINE
046O35D44RPRILOCAINE721-50-6PRILOCAINE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-3856-3680713856031 TUBE in 1 CARTON (68071-3856-3) / 30 g in 1 TUBE1 tube2025-05-30NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Lidocaine and Prilocaine Cream, USP 2.5%/2.5%NuCare Pharmaceuticals, Inc.2025-05-30HUMAN PRESCRIPTION DRUG LABEL1