FDA.reportPublic FDA data

LEVETIRACETAM

Product NDC
72485-106
11-digit product format
724850106
Labeler code
72485
Product ID
72485-106_19255a4c-a8da-4e24-9633-16b9e3fc1f89
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LEVETIRACETAM
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Armas Pharmaceuticals Inc.
Application
ANDA211954
Marketing category
ANDA
Marketing start
2021-01-14
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
72485-106-01LEVETIRACETAM5 mL in 1 VIAL, SINGLE-DOSEINJECTION54
72485-106-10LEVETIRACETAM10 in 1 CARTONINJECTION104
72485-106-25LEVETIRACETAM25 in 1 CARTONINJECTION254

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72485-106-01ML - Milliliter72485-1063112294e-109f-4f50-82dc-b003db726a2012021-02-05
72485-106-10ML - Milliliter72485-106af03cab7-5fa9-494f-a6b5-bd465f36d83512021-02-05
72485-106-25ML - Milliliter72485-10664d057cb-c62d-448d-9ae6-96f41b8f304d12023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72485-106LEVETIRACETAM (LEVETIRACETAM) INJECTION [ARMAS PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 3 package rows20230811_7be45c40-8d75-4c40-97a4-95067129bc2a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
647121levETIRAcetam 500 MG in 5 ML InjectionPSN7be45c40-8d75-4c40-97a4-95067129bc2a4
6471215 ML levetiracetam 100 MG/ML InjectionSCD7be45c40-8d75-4c40-97a4-95067129bc2a4
647121levetiracetam 500 MG per 5 ML InjectionSY7be45c40-8d75-4c40-97a4-95067129bc2a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72485-106-01724850106015 mL in 1 VIAL, SINGLE-DOSE5 mlHistorical
72485-106-107248501061010 VIAL, SINGLE-DOSE in 1 CARTON (72485-106-10) / 5 mL in 1 VIAL, SINGLE-DOSE (72485-106-01) 2021-01-140000-00-00NoNoCurrent
72485-106-257248501062525 VIAL, SINGLE-DOSE in 1 CARTON (72485-106-25) / 5 mL in 1 VIAL, SINGLE-DOSE (72485-106-01) 2023-03-16NoNoHistorical