FDA.reportPublic FDA data

Levetiracetam

Product NDC
65145-173
11-digit product format
651450173
Labeler code
65145
Product ID
65145-173_b14657e5-789e-4933-aeb9-78509d79b792
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam in Sodium Chloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Caplin Steriles Limited
Application
ANDA219562
Marketing category
ANDA
Marketing start
2025-06-24
Substance
LEVETIRACETAM
Active strength
500 mg/100mL
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/100mL

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
65145-173-01Levetiracetam1 in 1 POUCHINJECTION12
65145-173-01Levetiracetam100 mL in 1 BAGINJECTION1002
65145-173-10Levetiracetam10 in 1 CASEINJECTION102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65145-173-01ML - Milliliter65145-173e8fbc36f-83e3-4cc3-b8de-ec155bbf1d3312025-08-11
65145-173-10ML - Milliliter65145-17373d34fa9-5d99-42d3-98cf-84ad527630b612025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65145-173LEVETIRACETAM (LEVETIRACETAM IN SODIUM CHLORIDE) INJECTION [CAPLIN STERILES LIMITED]1Current NDC, 3 package rows20250131_563171fb-df26-4f95-853a-fd7707da291c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1193358levETIRAcetam 1000 MG in 100 ML InjectionPSN563171fb-df26-4f95-853a-fd7707da291c2
1193360levETIRAcetam 1500 MG in 100 ML InjectionPSN563171fb-df26-4f95-853a-fd7707da291c2
1193362levETIRAcetam 500 MG in 100 ML InjectionPSN563171fb-df26-4f95-853a-fd7707da291c2
1193358100 ML levetiracetam 10 MG/ML InjectionSCD563171fb-df26-4f95-853a-fd7707da291c2
1193360100 ML levetiracetam 15 MG/ML InjectionSCD563171fb-df26-4f95-853a-fd7707da291c2
1193362100 ML levetiracetam 5 MG/ML InjectionSCD563171fb-df26-4f95-853a-fd7707da291c2
1193358levetiracetam 1000 MG per 100 ML InjectionSY563171fb-df26-4f95-853a-fd7707da291c2
1193360levetiracetam 1500 MG per 100 ML InjectionSY563171fb-df26-4f95-853a-fd7707da291c2
1193362levetiracetam 500 MG per 100 ML InjectionSY563171fb-df26-4f95-853a-fd7707da291c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65145-173-01651450173011 in 1 POUCHHistorical
65145-173-106514501731010 POUCH in 1 CASE (65145-173-10) / 1 BAG in 1 POUCH (65145-173-01) / 100 mL in 1 BAG10 pouch2025-06-24NoNoHistorical