FDA.reportPublic FDA data

levetiracetam

Product NDC
25021-795
11-digit product format
250210795
Labeler code
25021
Product ID
25021-795_15958c84-c55b-4873-8a99-ec32b7446900
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levetiracetam
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA206880
Marketing category
ANDA
Marketing start
2024-09-15
Substance
LEVETIRACETAM
Active strength
15 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
LEVETIRACETAM15 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii44YRR34555
Rxcui1193358, 1193360, 1193362

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
25021-795-82levetiracetam10 in 1 CARTONINJECTION, SOLUTION101
25021-795-82levetiracetam100 mL in 1 BAGINJECTION, SOLUTION1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-795-82ML - Milliliter25021-7959dbcbd6e-887b-4b1f-9cdc-3b9a240a66c112024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-795LEVETIRACETAM INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]1Current NDC, 2 package rows20240915_d2de9565-0c0b-4957-bafa-1a286103709e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1193358levETIRAcetam 1000 MG in 100 ML InjectionPSNd2de9565-0c0b-4957-bafa-1a286103709e1
1193360levETIRAcetam 1500 MG in 100 ML InjectionPSNd2de9565-0c0b-4957-bafa-1a286103709e1
1193362levETIRAcetam 500 MG in 100 ML InjectionPSNd2de9565-0c0b-4957-bafa-1a286103709e1
1193358100 ML levetiracetam 10 MG/ML InjectionSCDd2de9565-0c0b-4957-bafa-1a286103709e1
1193360100 ML levetiracetam 15 MG/ML InjectionSCDd2de9565-0c0b-4957-bafa-1a286103709e1
1193362100 ML levetiracetam 5 MG/ML InjectionSCDd2de9565-0c0b-4957-bafa-1a286103709e1
1193358levetiracetam 1000 MG per 100 ML InjectionSYd2de9565-0c0b-4957-bafa-1a286103709e1
1193360levetiracetam 1500 MG per 100 ML InjectionSYd2de9565-0c0b-4957-bafa-1a286103709e1
1193362levetiracetam 500 MG per 100 ML InjectionSYd2de9565-0c0b-4957-bafa-1a286103709e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
25021-795-822502107958210 BAG in 1 CARTON (25021-795-82) / 100 mL in 1 BAG10 bag2024-09-15NoNoHistorical