FDA.reportPublic FDA data

Levetiracetam in Sodium Chloride

Product NDC
0143-9283
11-digit product format
001439283
Labeler code
0143
Product ID
0143-9283_f3105bfa-50ba-4e2f-8eae-0313242d8dcf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam in Sodium Chloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA211356
Marketing category
ANDA
Marketing start
2025-02-08
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 in Sodium Chloride
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
0143-9283-01Levetiracetam in Sodium Chloride100 mL in 1 BAGINJECTION1003
0143-9283-10Levetiracetam in Sodium Chloride10 in 1 BOXINJECTION103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9283-01ML - Milliliter0143-92834559c32d-31e9-4d28-b027-294fe985aeda12025-10-14
0143-9283-10ML - Milliliter0143-9283d0bd2fb6-01da-413a-872e-ccf1f8c8f4dc12025-10-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9283LEVETIRACETAM IN SODIUM CHLORIDE INJECTION [HIKMA PHARMACEUTICALS USA INC.]3Current NDC, 2 package rows20250322_c723fd27-214c-45f6-b170-a3b807ffab07.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1193358levETIRAcetam 1000 MG in 100 ML InjectionPSNc723fd27-214c-45f6-b170-a3b807ffab073
1193360levETIRAcetam 1500 MG in 100 ML InjectionPSNc723fd27-214c-45f6-b170-a3b807ffab073
1193362levETIRAcetam 500 MG in 100 ML InjectionPSNc723fd27-214c-45f6-b170-a3b807ffab073
1193358100 ML levetiracetam 10 MG/ML InjectionSCDc723fd27-214c-45f6-b170-a3b807ffab073
1193360100 ML levetiracetam 15 MG/ML InjectionSCDc723fd27-214c-45f6-b170-a3b807ffab073
1193362100 ML levetiracetam 5 MG/ML InjectionSCDc723fd27-214c-45f6-b170-a3b807ffab073
1193358levetiracetam 1000 MG per 100 ML InjectionSYc723fd27-214c-45f6-b170-a3b807ffab073
1193360levetiracetam 1500 MG per 100 ML InjectionSYc723fd27-214c-45f6-b170-a3b807ffab073
1193362levetiracetam 500 MG per 100 ML InjectionSYc723fd27-214c-45f6-b170-a3b807ffab073

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0143-9283-0100143928301100 mL in 1 BAG100 mlHistorical
0143-9283-100014392831010 BAG in 1 BOX (0143-9283-10) / 100 mL in 1 BAG (0143-9283-01) 10 bag2025-02-08NoNoHistorical