FDA.reportPublic FDA data

Levetiracetam

Product NDC
31722-539
11-digit product format
317220539
Labeler code
31722
Product ID
31722-539_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
1000 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
LEVETIRACETAM1000 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
31722-539-05Levetiracetam500 in 1 BOTTLETABLET, FILM COATED5009
31722-539-12Levetiracetam120 in 1 BOTTLETABLET, FILM COATED1209
31722-539-30Levetiracetam30 in 1 BOTTLETABLET, FILM COATED309
31722-539-60Levetiracetam60 in 1 BOTTLETABLET, FILM COATED609

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-539-60EA - Each31722-539a17fc658-4830-4b26-9278-37b27ed5a10212012-07-24

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
31722-539LEVETIRACETAM (LEVETIRACETAM) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]9Current NDC, Legacy NDC, 4 package rows20240430_63b36274-89f0-42d8-9f09-f9e78e179af4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
387003levETIRAcetam 1000 MG Oral TabletPSNb9597cd5-5745-494a-bd72-93071ed221da36
311289levETIRAcetam 500 MG Oral TabletPSNb9597cd5-5745-494a-bd72-93071ed221da36
387003levetiracetam 1000 MG Oral TabletSCDb9597cd5-5745-494a-bd72-93071ed221da36
311289levetiracetam 500 MG Oral TabletSCDb9597cd5-5745-494a-bd72-93071ed221da36
387003levETIRAcetam 1000 MG Oral TabletPSNae405796-1eca-4890-bcb2-e1b07654a24d14
387003levetiracetam 1000 MG Oral TabletSCDae405796-1eca-4890-bcb2-e1b07654a24d14
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
31722-539-0531722053905500 TABLET, FILM COATED in 1 BOTTLE (31722-539-05) 2010-10-080000-00-00NoNoCurrent
31722-539-1231722053912120 TABLET, FILM COATED in 1 BOTTLE (31722-539-12) 2010-10-080000-00-00NoNoCurrent
31722-539-303172205393030 TABLET, FILM COATED in 1 BOTTLE (31722-539-30) 2010-10-080000-00-00NoNoCurrent
31722-539-603172205396060 TABLET, FILM COATED in 1 BOTTLE (31722-539-60) 2010-10-080000-00-00NoNoCurrent