FDA.reportPublic FDA data

Levetiracetam

Product NDC
0143-9673
11-digit product format
001439673
Labeler code
0143
Product ID
0143-9673_15a7f063-f0e7-49dd-a520-f5708e5e8027
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA090981
Marketing category
ANDA
Marketing start
2011-10-13
Substance
LEVETIRACETAM
Active strength
100 mg/mL
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
LEVETIRACETAM100 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii44YRR34555
Rxcui647121

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
76e81f18-c6b9-f226-530a-a6296d5cd5f4Product name620251106
087c9486-f4a9-a565-c6fb-d6fa49f4572aProduct name620230317
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
525a8d4d-1988-fc3f-e292-27fd384de4f0Product name820230104
32b651f8-caa7-6882-11c7-54c4ad21796bProduct name820201216
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
ce453ca5-90cf-41ed-9de4-de519f70a0f2Product name220160303
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
66666eb8-1fa6-4a60-bae9-e564e73b4cd5Product name120150728
eecbc0ef-ab5c-4ff9-8aaa-6ea73ee46477Product name120150410
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9673-01Levetiracetam5 mL in 1 VIAL, GLASSINJECTION515
0143-9673-10Levetiracetam10 in 1 BOXINJECTION1015
0143-9673-25Levetiracetam25 in 1 CARTONINJECTION2515

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9673-01ML - Milliliter0143-9673cc20547c-68fe-4328-87d7-2653461b1dc512015-11-12
0143-9673-10ML - Milliliter0143-96738f97d1ce-cce7-4793-93b8-f7e0cbc4b0f412012-07-24
0143-9673-25ML - Milliliter0143-96731453913d-19bb-44e9-a450-4e540b38b39212016-09-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVETIRACETAMACTIVE INGREDIENT44YRR34555LEVETIRACETAM INJECTION [WEST-WARD PHARMACEUTICALS CORP]4
LEVETIRACETAMACTIVE MOIETY44YRR34555LEVETIRACETAM INJECTION [WEST-WARD PHARMACEUTICALS CORP]4
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PLEVETIRACETAM INJECTION [WEST-WARD PHARMACEUTICALS CORP]4
SODIUM ACETATEINACTIVE INGREDIENT4550K0SC9BLEVETIRACETAM INJECTION [WEST-WARD PHARMACEUTICALS CORP]4
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XLEVETIRACETAM INJECTION [WEST-WARD PHARMACEUTICALS CORP]4
WATERINACTIVE INGREDIENT059QF0KO0RLEVETIRACETAM INJECTION [WEST-WARD PHARMACEUTICALS CORP]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9673LEVETIRACETAM INJECTION [HIKMA PHARMACEUTICALS USA INC.]14Current NDC, Legacy NDC, 3 package rows20240418_8d767545-1eb9-45a5-bd16-e8a66e628fea.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
647121levETIRAcetam 500 MG in 5 ML InjectionPSN8d767545-1eb9-45a5-bd16-e8a66e628fea15
6471215 ML levetiracetam 100 MG/ML InjectionSCD8d767545-1eb9-45a5-bd16-e8a66e628fea15
647121levetiracetam 500 MG per 5 ML InjectionSY8d767545-1eb9-45a5-bd16-e8a66e628fea15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9673-01001439673015 mL in 1 VIAL, GLASS5 mlHistorical
0143-9673-100014396731010 VIAL, GLASS in 1 BOX (0143-9673-10) / 5 mL in 1 VIAL, GLASS (0143-9673-01) 2011-10-130000-00-00NoNoCurrent
0143-9673-250014396732525 VIAL, GLASS in 1 CARTON (0143-9673-25) / 5 mL in 1 VIAL, GLASS (0143-9673-01) 2011-10-130000-00-00NoNoCurrent