LENALIDOMIDE

Product NDC
70710-1033
11-digit product format
707101033
Labeler code
70710
Product ID
70710-1033_d06dec99-06d1-4525-9caf-460747b53fbc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LENALIDOMIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA210154
Marketing category
ANDA
Marketing start
2022-09-12
Substance
LENALIDOMIDE
Active strength
15 mg/1
Pharmacologic classes
Thalidomide Analog [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
F0P408N6V4LENALIDOMIDE191732-72-6LENALIDOMIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70710-1033-170710103301100 CAPSULE in 1 BOTTLE (70710-1033-1) 100 capsule2022-09-12NoNoHistorical
70710-1033-87071010330821 CAPSULE in 1 BOTTLE (70710-1033-8) 21 capsule2022-09-12NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
LENALIDOMIDEZydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited2024-02-10HUMAN PRESCRIPTION DRUG LABEL7