FDA.reportPublic FDA data

Levetiracetam

Product NDC
72205-120
11-digit product format
722050120
Labeler code
72205
Product ID
72205-120_e1381fe9-298e-47e3-996c-808e0a9dd643
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA215980
Marketing category
ANDA
Marketing start
2022-11-15
Substance
LEVETIRACETAM
Active strength
500 mg/5mL
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
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/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
72205-120-07Levetiracetam10 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE102
72205-120-07Levetiracetam5 mL in 1 VIALINJECTION, SOLUTION, CONCENTRATE52
72205-120-25Levetiracetam25 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE252
72205-120-25Levetiracetam5 mL in 1 VIALINJECTION, SOLUTION, CONCENTRATE52

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-120-07ML - Milliliter72205-120a6746a54-d319-4487-b0b5-b5f05c4ef59712023-12-05
72205-120-25ML - Milliliter72205-1201ba8161c-6cb1-49de-9a0b-46c4c12c90a712023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-120LEVETIRACETAM INJECTION, SOLUTION, CONCENTRATE [NOVADOZ PHARMACEUTICALS LLC]2Current NDC, 4 package rows20241205_484e8d8f-be40-46f8-a509-d1bbdbbd2981.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
647121levETIRAcetam 500 MG in 5 ML InjectionPSN65a76fcb-31a8-4c5a-9ffe-5393fc4dac34100
6471215 ML levetiracetam 100 MG/ML InjectionSCD65a76fcb-31a8-4c5a-9ffe-5393fc4dac34100
647121levetiracetam 500 MG per 5 ML InjectionSY65a76fcb-31a8-4c5a-9ffe-5393fc4dac34100
647121levETIRAcetam 500 MG in 5 ML InjectionPSN484e8d8f-be40-46f8-a509-d1bbdbbd29812
6471215 ML levetiracetam 100 MG/ML InjectionSCD484e8d8f-be40-46f8-a509-d1bbdbbd29812
647121levetiracetam 500 MG per 5 ML InjectionSY484e8d8f-be40-46f8-a509-d1bbdbbd29812

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72205-120-077220501200710 VIAL in 1 CARTON (72205-120-07) / 5 mL in 1 VIAL10 vial2023-02-09NoNoCurrent
72205-120-257220501202525 VIAL in 1 CARTON (72205-120-25) / 5 mL in 1 VIAL25 vial2023-02-09NoNoCurrent