Home NDC 42254-310 Levetiracetam
Product NDC 42254-310
11-digit product format 422540310
Labeler code 42254
Product ID 42254-310_41a781b4-da67-4650-a99b-593fc34465da
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Levetiracetam
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Rebel Distributors Corp
Application ANDA078154
Marketing category ANDA
Marketing start 2009-01-01
Marketing end 0000-00-00
Substance LEVETIRACETAM
Active strength 250 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42254-310-60 Levetiracetam 60 in 1 BOTTLE TABLET, FILM COATED 60 1 42254-310-72 Levetiracetam 120 in 1 BOTTLE TABLET, FILM COATED 120 1
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 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U LEVETIRACETAM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK LEVETIRACETAM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK LEVETIRACETAM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO LEVETIRACETAM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LEVETIRACETAM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A LEVETIRACETAM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 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 TALC INACTIVE INGREDIENT 7SEV7J4R1U LEVETIRACETAM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LEVETIRACETAM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42254-310 LEVETIRACETAM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 Legacy NDC, 2 package rows 20130228_41a781b4-da67-4650-a99b-593fc34465da.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 42254-310-60 42254031060 60 in 1 BOTTLE Historical 42254-310-72 42254031072 120 in 1 BOTTLE Historical