FDA.reportPublic FDA data

LEVETIRACETAM

Product NDC
58657-860
11-digit product format
586570860
Labeler code
58657
Product ID
58657-860_47cfd9a6-663a-7cc6-e063-6294a90a4666
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levetiracetam
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Method Pharmaceuticals, LLC
Application
ANDA209781
Marketing category
ANDA
Marketing start
2025-12-15
Substance
LEVETIRACETAM
Active strength
500 mg/5mL
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
LEVETIRACETAM
Listing expiration
2027-12-31

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
58657-860-00LEVETIRACETAM5 mL in 1 VIAL, SINGLE-DOSEINJECTION51
58657-860-01LEVETIRACETAM1 in 1 CARTONINJECTION11
58657-860-10LEVETIRACETAM10 in 1 CARTONINJECTION101
58657-860-25LEVETIRACETAM25 in 1 CARTONINJECTION251

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58657-860-01ML - Milliliter58657-8604d8c8da7-578f-4d9b-b3df-efd7434bbcc312026-02-05
58657-860-10ML - Milliliter58657-860f95e9a19-34b5-492c-ae12-a28a2e683e5212026-02-05
58657-860-25ML - Milliliter58657-860053c495b-6451-41b1-9d52-2a52ac7c092112026-02-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
647121levETIRAcetam 500 MG in 5 ML InjectionPSN47cfe577-b4cb-d35e-e063-6394a90ad8c41
6471215 ML levetiracetam 100 MG/ML InjectionSCD47cfe577-b4cb-d35e-e063-6394a90ad8c41
647121levetiracetam 500 MG per 5 ML InjectionSY47cfe577-b4cb-d35e-e063-6394a90ad8c41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58657-860-00586570860005 mL in 1 VIAL, SINGLE-DOSE5 mlHistorical
58657-860-01586570860011 VIAL, SINGLE-DOSE in 1 CARTON (58657-860-01) / 5 mL in 1 VIAL, SINGLE-DOSE (58657-860-00) 2025-12-15NoNoCurrent
58657-860-105865708601010 VIAL, SINGLE-DOSE in 1 CARTON (58657-860-10) / 5 mL in 1 VIAL, SINGLE-DOSE (58657-860-00) 2025-12-15NoNoCurrent
58657-860-255865708602525 VIAL, SINGLE-DOSE in 1 CARTON (58657-860-25) / 5 mL in 1 VIAL, SINGLE-DOSE (58657-860-00) 2025-12-15NoNoCurrent