Home NDC 42043-193 Levetiracetam
Product NDC 42043-193
11-digit product format 420430193
Labeler code 42043
Product ID 42043-193_fe7e0c86-8007-4af5-965c-184c6dbce17d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Levetiracetam
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Karalex Pharma LLC
Application ANDA090484
Marketing category ANDA
Marketing start 2011-09-01
Marketing end 0000-00-00
Substance LEVETIRACETAM
Active strength 1000 mg/1
Pharmacologic classes Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag E
Listing certified through 2017-12-31
Current FDA listing Historical FDA.report record DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Levetiracetam ACTIVE INGREDIENT 44YRR34555 LEVETIRACETAM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 Levetiracetam ACTIVE MOIETY 44YRR34555 LEVETIRACETAM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 LEVETIRACETAM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK LEVETIRACETAM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 HYPROMELLOSE 2910 (3 MPA.S) INACTIVE INGREDIENT 0VUT3PMY82 LEVETIRACETAM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 LEVETIRACETAM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LEVETIRACETAM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 POLYETHYLENE GLYCOL 4000 INACTIVE INGREDIENT 4R4HFI6D95 LEVETIRACETAM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 POLYETHYLENE GLYCOL 6000 INACTIVE INGREDIENT 30IQX730WE LEVETIRACETAM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E LEVETIRACETAM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 LEVETIRACETAM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ LEVETIRACETAM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LEVETIRACETAM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1
DailyMed RxNorm Mappings#