FDA.reportPublic FDA data

Levetiracetam

Product NDC
71205-881
11-digit product format
712050881
Labeler code
71205
Product ID
71205-881_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
750 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
LEVETIRACETAM750 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
71205-881-00LevetiracetamER100 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE1002
71205-881-11LevetiracetamER1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE10002
71205-881-30LevetiracetamER30 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE302
71205-881-55LevetiracetamER500 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE5002
71205-881-60LevetiracetamER60 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE602
71205-881-64LevetiracetamER240 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE2402
71205-881-72LevetiracetamER120 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE1202
71205-881-78LevetiracetamER180 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE1802
71205-881-90LevetiracetamER90 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
71205-881-00EA - Each71205-88151af154f-ee52-46a2-bd17-a6ec812bf2fc12021-12-08
71205-881-11EA - Each71205-881b2aceae8-2b2d-4107-8caf-7d5d64f4006312021-12-08
71205-881-30EA - Each71205-881187a4ffc-0cda-4ec8-bf83-a5597eca443f12021-12-08
71205-881-55EA - Each71205-881ac04083c-5df1-4a39-8b72-661060c1449812021-12-08
71205-881-60EA - Each71205-8819e2199d5-395b-433d-9744-f38b9e0334c912021-12-08
71205-881-64EA - Each71205-881c6b941c1-b8f2-444b-aee9-ec39c77e843912021-12-08
71205-881-72EA - Each71205-8813848794e-5101-42c4-806a-bde4190843c112021-12-08
71205-881-78EA - Each71205-881cce41bd7-a3ba-47b3-b2ac-25b15246405b12021-12-08
71205-881-90EA - Each71205-881661f46e1-209f-48bf-8275-f38d700e1c3e12021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-881LEVETIRACETAM 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
71205-881-0071205088100100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71205-881-00) 2021-11-050000-00-00NoNoCurrent
71205-881-11712050881111000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71205-881-11) 2021-11-050000-00-00NoNoCurrent
71205-881-307120508813030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71205-881-30) 2021-11-050000-00-00NoNoCurrent
71205-881-5571205088155500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71205-881-55) 2021-11-050000-00-00NoNoCurrent
71205-881-607120508816060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71205-881-60) 2021-11-050000-00-00NoNoCurrent
71205-881-6471205088164240 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71205-881-64) 2021-11-050000-00-00NoNoCurrent
71205-881-7271205088172120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71205-881-72) 2021-11-050000-00-00NoNoCurrent
71205-881-7871205088178180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71205-881-78) 2021-11-050000-00-00NoNoCurrent
71205-881-907120508819090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71205-881-90) 2021-11-050000-00-00NoNoCurrent