FDA.reportPublic FDA data

Levetiracetam

Product NDC
71205-880
11-digit product format
712050880
Labeler code
71205
Product ID
71205-880_cb0d9a15-fb02-4393-bdf7-a88dc4b42d6a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA205130
Marketing category
ANDA
Marketing start
2021-09-30
Substance
LEVETIRACETAM
Active strength
500 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
Levetiracetam
Brand name suffix
ER
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVETIRACETAM500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii44YRR34555
Rxcui807832, 846378

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-880-00LevetiracetamER100 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE1002
71205-880-11LevetiracetamER1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE10002
71205-880-30LevetiracetamER30 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE302
71205-880-55LevetiracetamER500 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE5002
71205-880-60LevetiracetamER60 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE602
71205-880-64LevetiracetamER240 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE2402
71205-880-72LevetiracetamER120 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE1202
71205-880-78LevetiracetamER180 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE1802
71205-880-90LevetiracetamER90 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-880-00EA - Each71205-8805e10f518-6576-4e14-91e0-a6783dfde12312021-12-08
71205-880-11EA - Each71205-88055d44b9b-8903-4fa0-8cab-59bce055964a12021-12-08
71205-880-30EA - Each71205-880f6240250-8c68-419b-a4c0-04a6d8a6116c12021-12-08
71205-880-55EA - Each71205-8809ec62d16-abff-4442-ba26-9220adfe090b12021-12-08
71205-880-60EA - Each71205-88050ffa200-5bbe-4c66-995b-eb031f34298712021-12-08
71205-880-64EA - Each71205-880dfb0db65-117e-4675-b9d3-b76f65ff519c12021-12-08
71205-880-72EA - Each71205-8803e4decb6-7c6f-4934-bcae-5c546eeb061812021-12-08
71205-880-78EA - Each71205-88047e890a4-4702-4397-baa4-cb7ce844a54112021-12-08
71205-880-90EA - Each71205-8809976976e-4c46-4371-a6b4-ea6d790d61c512021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-880LEVETIRACETAM ER (LEVETIRACETAM) TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP]2Current NDC, Legacy NDC, 9 package rows20220412_57b9dccb-6ee6-4e89-ab26-4c478e2df2b5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
807832levETIRAcetam 500 MG 24HR Extended Release Oral TabletPSN57b9dccb-6ee6-4e89-ab26-4c478e2df2b52
846378levETIRAcetam 750 MG 24HR Extended Release Oral TabletPSN57b9dccb-6ee6-4e89-ab26-4c478e2df2b52
80783224 HR levetiracetam 500 MG Extended Release Oral TabletSCD57b9dccb-6ee6-4e89-ab26-4c478e2df2b52
84637824 HR levetiracetam 750 MG Extended Release Oral TabletSCD57b9dccb-6ee6-4e89-ab26-4c478e2df2b52
807832levetiracetam 500 MG 24 HR Extended Release Oral TabletSY57b9dccb-6ee6-4e89-ab26-4c478e2df2b52
846378levetiracetam 750 MG 24 HR Extended Release Oral TabletSY57b9dccb-6ee6-4e89-ab26-4c478e2df2b52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-880-0071205088000100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71205-880-00) 2021-11-050000-00-00NoNoCurrent
71205-880-11712050880111000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71205-880-11) 2021-11-050000-00-00NoNoCurrent
71205-880-307120508803030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71205-880-30) 2021-11-050000-00-00NoNoCurrent
71205-880-5571205088055500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71205-880-55) 2021-11-050000-00-00NoNoCurrent
71205-880-607120508806060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71205-880-60) 2021-11-050000-00-00NoNoCurrent
71205-880-6471205088064240 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71205-880-64) 2021-11-050000-00-00NoNoCurrent
71205-880-7271205088072120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71205-880-72) 2021-11-050000-00-00NoNoCurrent
71205-880-7871205088078180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71205-880-78) 2021-11-050000-00-00NoNoCurrent
71205-880-907120508809090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71205-880-90) 2021-11-050000-00-00NoNoCurrent