FDA.reportPublic FDA data

LEVETIRACETAM

Product NDC
70752-203
11-digit product format
707520203
Labeler code
70752
Product ID
70752-203_339d66da-457a-4267-806b-7673122db283
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LEVETIRACETAM
Dosage form
SOLUTION
Route
ORAL
Labeler
QUAGEN PHARMACEUTICALS LLC
Application
ANDA090079
Marketing category
ANDA
Marketing start
2025-02-01
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
Rxcui403884

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
76e81f18-c6b9-f226-530a-a6296d5cd5f4Product name620251106
087c9486-f4a9-a565-c6fb-d6fa49f4572aProduct name620230317
525a8d4d-1988-fc3f-e292-27fd384de4f0Product name820230104
32b651f8-caa7-6882-11c7-54c4ad21796bProduct name820201216
ce453ca5-90cf-41ed-9de4-de519f70a0f2Product name220160303
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
66666eb8-1fa6-4a60-bae9-e564e73b4cd5Product name120150728
eecbc0ef-ab5c-4ff9-8aaa-6ea73ee46477Product name120150410

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70752-203-02LEVETIRACETAM15 mL in 1 CUP, UNIT-DOSESOLUTION151
70752-203-02LEVETIRACETAM10 in 1 TRAYSOLUTION101
70752-203-12LEVETIRACETAM473 mL in 1 BOTTLESOLUTION4731
70752-203-16LEVETIRACETAM10 in 1 TRAYSOLUTION101
70752-203-16LEVETIRACETAM5 mL in 1 CUP, UNIT-DOSESOLUTION51
70752-203-27LEVETIRACETAM10 mL in 1 CUP, UNIT-DOSESOLUTION101
70752-203-27LEVETIRACETAM10 in 1 TRAYSOLUTION101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70752-203-12ML - Milliliter70752-20343384d08-5e22-4d7d-ac95-a721dd25474e12025-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70752-203LEVETIRACETAM SOLUTION [QUAGEN PHARMACEUTICALS LLC]1Current NDC, 7 package rows20250406_1d67cb3c-1173-4dce-a79b-a3c36934ab2e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403884levETIRAcetam 100 MG in 1 mL Oral SolutionPSN1d67cb3c-1173-4dce-a79b-a3c36934ab2e1
403884levetiracetam 100 MG/ML Oral SolutionSCD1d67cb3c-1173-4dce-a79b-a3c36934ab2e1
403884levetiracetam 100 MG per 1 ML Oral SolutionSY1d67cb3c-1173-4dce-a79b-a3c36934ab2e1
403884levetiracetam 1000 MG per 10 ML Oral SolutionSY1d67cb3c-1173-4dce-a79b-a3c36934ab2e1
403884levetiracetam 1500 MG per 15 ML Oral SolutionSY1d67cb3c-1173-4dce-a79b-a3c36934ab2e1
403884levetiracetam 500 MG per 5 ML Oral SolutionSY1d67cb3c-1173-4dce-a79b-a3c36934ab2e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70752-203-027075202030210 CUP, UNIT-DOSE in 1 TRAY (70752-203-02) / 15 mL in 1 CUP, UNIT-DOSE2025-02-01NoNoCurrent
70752-203-1270752020312473 mL in 1 BOTTLE (70752-203-12) 473 ml2025-02-01NoNoCurrent
70752-203-167075202031610 CUP, UNIT-DOSE in 1 TRAY (70752-203-16) / 5 mL in 1 CUP, UNIT-DOSE2025-02-01NoNoCurrent
70752-203-277075202032710 CUP, UNIT-DOSE in 1 TRAY (70752-203-27) / 10 mL in 1 CUP, UNIT-DOSE2025-02-01NoNoCurrent