FDA.reportPublic FDA data

LEVETIRACETAM

Product NDC
43547-454
11-digit product format
435470454
Labeler code
43547
Product ID
43547-454_2528785e-b8b2-4e7a-9787-54766f62c6bb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levetiracetam
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Solco Healthcare US, LLC
Application
ANDA209474
Marketing category
ANDA
Marketing start
2022-04-11
Substance
LEVETIRACETAM
Active strength
500 mg/5mL
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
LEVETIRACETAM500 mg/5mL

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
43547-454-10LEVETIRACETAM10 in 1 CARTONINJECTION103
43547-454-41LEVETIRACETAM5 mL in 1 VIAL, SINGLE-DOSEINJECTION53

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43547-454-10ML - Milliliter43547-4542ff5754e-e8da-4d87-a633-5ef49096065312022-08-04
43547-454-41ML - Milliliter43547-454d62209a9-d59b-4e7e-ad7d-6486c1a27eca12022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43547-454LEVETIRACETAM INJECTION [SOLCO HEALTHCARE US, LLC]1Current NDC, Legacy NDC, 2 package rows20220505_cfe618ae-f7de-43d8-a754-3ce0a08c48ee.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
647121levETIRAcetam 500 MG in 5 ML InjectionPSNcfe618ae-f7de-43d8-a754-3ce0a08c48ee3
6471215 ML levetiracetam 100 MG/ML InjectionSCDcfe618ae-f7de-43d8-a754-3ce0a08c48ee3
647121levetiracetam 500 MG per 5 ML InjectionSYcfe618ae-f7de-43d8-a754-3ce0a08c48ee3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43547-454-104354704541010 VIAL, SINGLE-DOSE in 1 CARTON (43547-454-10) / 5 mL in 1 VIAL, SINGLE-DOSE (43547-454-41) 2022-04-110000-00-00NoNoCurrent
43547-454-41435470454415 mL in 1 VIAL, SINGLE-DOSE5 mlHistorical