FDA.reportPublic FDA data

LEVETIRACETAM

Product NDC
0409-1886
11-digit product format
004091886
Labeler code
0409
Product ID
0409-1886_ba064ae4-ae86-4fc4-b0a9-0477d8db8727
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LEVETIRACETAM
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
ANDA202869
Marketing category
ANDA
Marketing start
2012-11-02
Substance
LEVETIRACETAM
Active strength
100 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
LEVETIRACETAM100 mg/mL

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
0409-1886-02LEVETIRACETAM25 in 1 CARTONINJECTION, SOLUTION2523
0409-1886-22LEVETIRACETAM5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION523

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-1886-02ML - Milliliter0409-18869b2a7b06-8c19-4e28-8857-01f16a7bf40c12013-02-13
0409-1886-05ML - Milliliter0409-188644e8bac9-346a-4cfd-bf38-d454745e753812018-03-08
0409-1886-15ML - Milliliter0409-1886d2d865df-e712-46d0-800e-96fc149edb2812018-03-08
0409-1886-22ML - Milliliter0409-18861e9301cf-122a-48d0-bfff-4439e01a4be312017-07-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVETIRACETAMACTIVE INGREDIENT44YRR34555LEVETIRACETAM INJECTION [HOSPIRA, INC.]4
LEVETIRACETAMACTIVE MOIETY44YRR34555LEVETIRACETAM INJECTION [HOSPIRA, INC.]4
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PLEVETIRACETAM INJECTION [HOSPIRA, INC.]4
SODIUM ACETATEINACTIVE INGREDIENT4550K0SC9BLEVETIRACETAM INJECTION [HOSPIRA, INC.]4
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XLEVETIRACETAM INJECTION [HOSPIRA, INC.]4
WATERINACTIVE INGREDIENT059QF0KO0RLEVETIRACETAM INJECTION [HOSPIRA, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-1886LEVETIRACETAM INJECTION, SOLUTION [HOSPIRA, INC.]23Current NDC, Legacy NDC, 2 package rows20240601_ed1b74a8-2a9b-4315-b051-673c7941cb13.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
647121levETIRAcetam 500 MG in 5 ML InjectionPSNed1b74a8-2a9b-4315-b051-673c7941cb1323
6471215 ML levetiracetam 100 MG/ML InjectionSCDed1b74a8-2a9b-4315-b051-673c7941cb1323
647121levetiracetam 500 MG per 5 ML InjectionSYed1b74a8-2a9b-4315-b051-673c7941cb1323

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-1886-020040918860225 VIAL, SINGLE-DOSE in 1 CARTON (0409-1886-02) / 5 mL in 1 VIAL, SINGLE-DOSE (0409-1886-22) 2012-11-020000-00-00NoNoCurrent
0409-1886-050040918860525 VIAL, SINGLE-USE in 1 CARTON (0409-1886-05) > 5 mL in 1 VIAL, SINGLE-USE (0409-1886-15) 2018-03-010000-00-00NoNoCurrent
0409-1886-22004091886225 mL in 1 VIAL, SINGLE-DOSE5 mlHistorical