FDA.reportPublic FDA data

Levetiracetam

Product NDC
31722-536
11-digit product format
317220536
Labeler code
31722
Product ID
31722-536_1735a6ea-d61a-8448-e063-6394a90a5940
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA090515
Marketing category
ANDA
Marketing start
2010-10-08
Substance
LEVETIRACETAM
Active strength
250 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Levetiracetam
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVETIRACETAM250 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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
087c9486-f4a9-a565-c6fb-d6fa49f4572aProduct name620230317
525a8d4d-1988-fc3f-e292-27fd384de4f0Product name820230104
32b651f8-caa7-6882-11c7-54c4ad21796bProduct name820201216
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
ce453ca5-90cf-41ed-9de4-de519f70a0f2Product name220160303
66666eb8-1fa6-4a60-bae9-e564e73b4cd5Product name120150728
eecbc0ef-ab5c-4ff9-8aaa-6ea73ee46477Product name120150410
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-536-05Levetiracetam500 in 1 BOTTLETABLET, FILM COATED5009
31722-536-10Levetiracetam1000 in 1 BOTTLETABLET, FILM COATED10009
31722-536-12Levetiracetam120 in 1 BOTTLETABLET, FILM COATED1209
31722-536-30Levetiracetam30 in 1 BOTTLETABLET, FILM COATED309
31722-536-60Levetiracetam60 in 1 BOTTLETABLET, FILM COATED609

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-536-05EA - Each31722-536f78fc4a1-13c6-4df9-91e9-4216f185383712012-07-24
31722-536-12EA - Each31722-536c178cf3a-a8ef-43dc-bdc9-293bd574b28c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVETIRACETAMACTIVE INGREDIENT44YRR34555LEVETIRACETAM TABLET, FILM COATED [CAMBER PHARMACEUTICALS]1
LEVETIRACETAMACTIVE MOIETY44YRR34555LEVETIRACETAM TABLET, FILM COATED [CAMBER PHARMACEUTICALS]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48LEVETIRACETAM TABLET, FILM COATED [CAMBER PHARMACEUTICALS]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKLEVETIRACETAM TABLET, FILM COATED [CAMBER PHARMACEUTICALS]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8LEVETIRACETAM TABLET, FILM COATED [CAMBER PHARMACEUTICALS]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LEVETIRACETAM TABLET, FILM COATED [CAMBER PHARMACEUTICALS]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLEVETIRACETAM TABLET, FILM COATED [CAMBER PHARMACEUTICALS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVETIRACETAM TABLET, FILM COATED [CAMBER PHARMACEUTICALS]1
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PLEVETIRACETAM TABLET, FILM COATED [CAMBER PHARMACEUTICALS]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990LEVETIRACETAM TABLET, FILM COATED [CAMBER PHARMACEUTICALS]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ELEVETIRACETAM TABLET, FILM COATED [CAMBER PHARMACEUTICALS]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LEVETIRACETAM TABLET, FILM COATED [CAMBER PHARMACEUTICALS]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLEVETIRACETAM TABLET, FILM COATED [CAMBER PHARMACEUTICALS]1
TALCINACTIVE INGREDIENT7SEV7J4R1ULEVETIRACETAM TABLET, FILM COATED [CAMBER PHARMACEUTICALS]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLEVETIRACETAM TABLET, FILM COATED [CAMBER PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-536LEVETIRACETAM (LEVETIRACETAM) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]9Current NDC, Legacy NDC, 5 package rows20240430_63b36274-89f0-42d8-9f09-f9e78e179af4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
387003levETIRAcetam 1000 MG Oral TabletPSN63b36274-89f0-42d8-9f09-f9e78e179af49
311288levETIRAcetam 250 MG Oral TabletPSN63b36274-89f0-42d8-9f09-f9e78e179af49
311289levETIRAcetam 500 MG Oral TabletPSN63b36274-89f0-42d8-9f09-f9e78e179af49
311290levETIRAcetam 750 MG Oral TabletPSN63b36274-89f0-42d8-9f09-f9e78e179af49
387003levetiracetam 1000 MG Oral TabletSCD63b36274-89f0-42d8-9f09-f9e78e179af49
311288levetiracetam 250 MG Oral TabletSCD63b36274-89f0-42d8-9f09-f9e78e179af49
311289levetiracetam 500 MG Oral TabletSCD63b36274-89f0-42d8-9f09-f9e78e179af49
311290levetiracetam 750 MG Oral TabletSCD63b36274-89f0-42d8-9f09-f9e78e179af49
311288levETIRAcetam 250 MG Oral TabletPSN419b3dba-ae21-4268-ac8b-342aaa6095548
311288levETIRAcetam 250 MG Oral TabletPSNc3b62114-a590-f4db-e053-2995a90a9d308
311289levETIRAcetam 500 MG Oral TabletPSNc3b62114-a590-f4db-e053-2995a90a9d308
311288levetiracetam 250 MG Oral TabletSCDc3b62114-a590-f4db-e053-2995a90a9d308
311288levetiracetam 250 MG Oral TabletSCD419b3dba-ae21-4268-ac8b-342aaa6095548
311289levetiracetam 500 MG Oral TabletSCDc3b62114-a590-f4db-e053-2995a90a9d308
311288levETIRAcetam 250 MG Oral TabletPSNadbcb0f7-0421-47e2-854e-e1cfefb6386f6
311289levETIRAcetam 500 MG Oral TabletPSNadbcb0f7-0421-47e2-854e-e1cfefb6386f6
311288levetiracetam 250 MG Oral TabletSCDadbcb0f7-0421-47e2-854e-e1cfefb6386f6
311289levetiracetam 500 MG Oral TabletSCDadbcb0f7-0421-47e2-854e-e1cfefb6386f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
31722-536-0531722053605500 TABLET, FILM COATED in 1 BOTTLE (31722-536-05) 2010-10-080000-00-00NoNoCurrent
31722-536-10317220536101000 TABLET, FILM COATED in 1 BOTTLE (31722-536-10) 2010-10-080000-00-00NoNoCurrent
31722-536-1231722053612120 TABLET, FILM COATED in 1 BOTTLE (31722-536-12) 2010-10-080000-00-00NoNoCurrent
31722-536-303172205363030 TABLET, FILM COATED in 1 BOTTLE (31722-536-30) 2010-10-080000-00-00NoNoCurrent
31722-536-603172205366060 TABLET, FILM COATED in 1 BOTTLE (31722-536-60) 2010-10-080000-00-00NoNoCurrent