FDA.reportPublic FDA data

Levetiracetam

Product NDC
68180-114
11-digit product format
681800114
Labeler code
68180
Product ID
68180-114_24fe2e98-0b9f-4eea-a745-e26002329cec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA078154
Marketing category
ANDA
Marketing start
2009-01-15
Substance
LEVETIRACETAM
Active strength
750 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Levetiracetam
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVETIRACETAM750 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii44YRR34555
Rxcui311288, 311289, 311290, 387003

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
76e81f18-c6b9-f226-530a-a6296d5cd5f4Product name620251106
087c9486-f4a9-a565-c6fb-d6fa49f4572aProduct name620230317
525a8d4d-1988-fc3f-e292-27fd384de4f0Product name820230104
32b651f8-caa7-6882-11c7-54c4ad21796bProduct name820201216
ce453ca5-90cf-41ed-9de4-de519f70a0f2Product name220160303
66666eb8-1fa6-4a60-bae9-e564e73b4cd5Product name120150728
eecbc0ef-ab5c-4ff9-8aaa-6ea73ee46477Product name120150410

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68180-114-02Levetiracetam500 in 1 BOTTLETABLET, FILM COATED50026
68180-114-09Levetiracetam90 in 1 BOTTLETABLET, FILM COATED9026
68180-114-16Levetiracetam120 in 1 BOTTLETABLET, FILM COATED12026

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-114-02EA - Each68180-114f02ced73-13d1-40ec-b455-cbc1325a74b812012-07-24
68180-114-09EA - Each68180-1140a547b3e-c72b-4c0a-8df4-63ccd45ff93412012-07-24
68180-114-16EA - Each68180-114ce15cfda-9285-42ed-bcde-db742582afd212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVETIRACETAMACTIVE INGREDIENT44YRR34555LEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]8
LEVETIRACETAMACTIVE MOIETY44YRR34555LEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]8
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]8
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48LEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]8
CROSPOVIDONEINACTIVE INGREDIENT68401960MKLEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]8
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKLEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]8
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8LEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]8
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]8
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]8
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82LEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]8
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6LEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]8
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D95LEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]8
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WELEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]8
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990LEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]8
POVIDONEINACTIVE INGREDIENTFZ989GH94ELEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]8
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]8
TALCINACTIVE INGREDIENT7SEV7J4R1ULEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]8
LEVETIRACETAMACTIVE INGREDIENT44YRR34555LEVETIRACETAM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
LEVETIRACETAMACTIVE MOIETY44YRR34555LEVETIRACETAM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULEVETIRACETAM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKLEVETIRACETAM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKLEVETIRACETAM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8LEVETIRACETAM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LEVETIRACETAM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLEVETIRACETAM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82LEVETIRACETAM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6LEVETIRACETAM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVETIRACETAM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D95LEVETIRACETAM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990LEVETIRACETAM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ELEVETIRACETAM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LEVETIRACETAM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLEVETIRACETAM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1ULEVETIRACETAM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLEVETIRACETAM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-114LEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]23Current NDC, Legacy NDC, 3 package rows20240418_df661166-325d-4071-9bc1-f7bf992996d2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311290levETIRAcetam 750 MG Oral TabletPSN90e01877-abcb-4697-a7ed-9afe5ee77050102
311290levetiracetam 750 MG Oral TabletSCD90e01877-abcb-4697-a7ed-9afe5ee77050102
387003levETIRAcetam 1000 MG Oral TabletPSNdf661166-325d-4071-9bc1-f7bf992996d226
311288levETIRAcetam 250 MG Oral TabletPSNdf661166-325d-4071-9bc1-f7bf992996d226
311289levETIRAcetam 500 MG Oral TabletPSNdf661166-325d-4071-9bc1-f7bf992996d226
311290levETIRAcetam 750 MG Oral TabletPSNdf661166-325d-4071-9bc1-f7bf992996d226
387003levetiracetam 1000 MG Oral TabletSCDdf661166-325d-4071-9bc1-f7bf992996d226
311288levetiracetam 250 MG Oral TabletSCDdf661166-325d-4071-9bc1-f7bf992996d226
311289levetiracetam 500 MG Oral TabletSCDdf661166-325d-4071-9bc1-f7bf992996d226
311290levetiracetam 750 MG Oral TabletSCDdf661166-325d-4071-9bc1-f7bf992996d226
311288levETIRAcetam 250 MG Oral TabletPSN80f5349c-3910-4c69-9f56-cb552bf4f3361
311289levETIRAcetam 500 MG Oral TabletPSN80f5349c-3910-4c69-9f56-cb552bf4f3361
311290levETIRAcetam 750 MG Oral TabletPSN80f5349c-3910-4c69-9f56-cb552bf4f3361
311288levetiracetam 250 MG Oral TabletSCD80f5349c-3910-4c69-9f56-cb552bf4f3361
311289levetiracetam 500 MG Oral TabletSCD80f5349c-3910-4c69-9f56-cb552bf4f3361
311290levetiracetam 750 MG Oral TabletSCD80f5349c-3910-4c69-9f56-cb552bf4f3361

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68180-114-0268180011402500 TABLET, FILM COATED in 1 BOTTLE (68180-114-02) 2009-01-150000-00-00NoNoCurrent
68180-114-096818001140990 TABLET, FILM COATED in 1 BOTTLE (68180-114-09) 2009-01-150000-00-00NoNoCurrent
68180-114-1668180011416120 TABLET, FILM COATED in 1 BOTTLE (68180-114-16) 2009-01-150000-00-00NoNoCurrent