FDA.reportPublic FDA data

Roweepra

Product NDC
69102-108
11-digit product format
691020108
Labeler code
69102
Product ID
69102-108_c7262ce0-c186-487b-9808-b340d31d8fe4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET
Route
ORAL
Labeler
OWP Pharmaceuticals, Inc.
Application
ANDA078858
Marketing category
ANDA
Marketing start
2020-10-28
Substance
LEVETIRACETAM
Active strength
250 mg/1
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
Roweepra
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVETIRACETAM250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii44YRR34555
Rxcui311288, 311289, 311290, 387003, 1875868

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
66666eb8-1fa6-4a60-bae9-e564e73b4cd5Product name120150728
eecbc0ef-ab5c-4ff9-8aaa-6ea73ee46477Product name120150410

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69102-108-012022-02-03C16284748780-1d6a99b39-97b2-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use ROWEEPRA (levetiracetam) TABLETS safely and effectively. See full prescribing information for ROWEEPRA TABLETS. ROWEEPRA (levetiracetam) tablets, for oral use Initial U.S. Approval: 1999
69102-108-012022-01-28C16284748780-1d6a99b39-97b2-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use ROWEEPRA (levetiracetam) TABLETS safely and effectively. See full prescribing information for ROWEEPRA TABLETS. ROWEEPRA (levetiracetam) tablets, for oral use Initial U.S. Approval: 1999

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69102-108-01Roweepra120 in 1 BOTTLETABLET1205

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69102-108ROWEEPRA (LEVETIRACETAM) TABLET LEVETIRACETAM TABLET [OWP PHARMACEUTICALS, INC.]5Current NDC, Legacy NDC, 1 package rows20250525_e662bf5b-c81c-4bcd-ba2e-552df95ca6f9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
387003levETIRAcetam 1000 MG Oral TabletPSNe662bf5b-c81c-4bcd-ba2e-552df95ca6f95
311288levETIRAcetam 250 MG Oral TabletPSNe662bf5b-c81c-4bcd-ba2e-552df95ca6f95
311289levETIRAcetam 500 MG Oral TabletPSNe662bf5b-c81c-4bcd-ba2e-552df95ca6f95
311290levETIRAcetam 750 MG Oral TabletPSNe662bf5b-c81c-4bcd-ba2e-552df95ca6f95
1875868Roweepra 250 MG Oral TabletPSNe662bf5b-c81c-4bcd-ba2e-552df95ca6f95
1875868levetiracetam 250 MG Oral Tablet [Roweepra]SBDe662bf5b-c81c-4bcd-ba2e-552df95ca6f95
387003levetiracetam 1000 MG Oral TabletSCDe662bf5b-c81c-4bcd-ba2e-552df95ca6f95
311288levetiracetam 250 MG Oral TabletSCDe662bf5b-c81c-4bcd-ba2e-552df95ca6f95
311289levetiracetam 500 MG Oral TabletSCDe662bf5b-c81c-4bcd-ba2e-552df95ca6f95
311290levetiracetam 750 MG Oral TabletSCDe662bf5b-c81c-4bcd-ba2e-552df95ca6f95
1875868Roweepra 250 MG Oral TabletSYe662bf5b-c81c-4bcd-ba2e-552df95ca6f95

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69102-108-0169102010801120 TABLET in 1 BOTTLE (69102-108-01) 120 tablet2020-10-280000-00-00NoNoCurrent