FDA.reportPublic FDA data

LYBALVI

Product NDC
65757-654
11-digit product format
657570654
Labeler code
65757
Product ID
65757-654_44ae69cc-b9a6-4658-90fa-1dbef1e97eb4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
olanzapine and samidorphan L-malate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Alkermes, Inc.
Application
NDA213378
Marketing category
NDA
Marketing start
2021-09-20
Substance
OLANZAPINE; SAMIDORPHAN L-MALATE
Active strength
20; 10 mg/1; mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC], Opioid Antagonist [EPC], Opioid Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
LYBALVI
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OLANZAPINE20 mg/1
SAMIDORPHAN L-MALATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN7U69T4SZR, 0AJQ5N56E0
Rxcui2570392, 2570398, 2570399, 2570401, 2570402, 2570404, 2570405, 2570407

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
42e9462d-db65-453b-8069-8fb2df9182e8Product name120211216
12d02c27-e8da-47f1-b815-ccca982731efProduct name920170802
877783eb-030c-6e3f-0979-804cf94d8856Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65757-654-40LYBALVI7 in 1 BOTTLETABLET, FILM COATED716
65757-654-40LYBALVI1 in 1 CARTONTABLET, FILM COATED116
65757-654-41LYBALVI7 in 1 BOTTLETABLET, FILM COATED716
65757-654-41LYBALVI1 in 1 CARTONTABLET, FILM COATED116
65757-654-42LYBALVI30 in 1 BOTTLETABLET, FILM COATED3016
65757-654-42LYBALVI1 in 1 CARTONTABLET, FILM COATED116
65757-654-44LYBALVI1 in 1 CARTONTABLET, FILM COATED116
65757-654-44LYBALVI90 in 1 BOTTLETABLET, FILM COATED9016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65757-654-40EA - Each65757-654957e1818-7ce9-4e2c-831d-6c47fd5d63b312023-12-05
65757-654-42EA - Each65757-654f57cb229-a18d-4a57-9a7f-74eb853dace712021-10-08
65757-654-44EA - Each65757-654a941e233-8b45-4510-94be-901e6fbfb52b12021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65757-654LYBALVI (OLANZAPINE AND SAMIDORPHAN L-MALATE) TABLET, FILM COATED [ALKERMES, INC.]13Current NDC, Legacy NDC, 8 package rows20250316_32ffddd1-4e2b-45d9-9b36-bb730167ec80.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2570401LYBALVI 10 MG / 10 MG Oral TabletPSN32ffddd1-4e2b-45d9-9b36-bb730167ec8016
2570404LYBALVI 15 MG / 10 MG Oral TabletPSN32ffddd1-4e2b-45d9-9b36-bb730167ec8016
2570407LYBALVI 20 MG / 10 MG Oral TabletPSN32ffddd1-4e2b-45d9-9b36-bb730167ec8016
2570398LYBALVI 5 MG / 10 MG Oral TabletPSN32ffddd1-4e2b-45d9-9b36-bb730167ec8016
2570399OLANZapine 10 MG / samidorphan 10 MG Oral TabletPSN32ffddd1-4e2b-45d9-9b36-bb730167ec8016
2570402OLANZapine 15 MG / samidorphan 10 MG Oral TabletPSN32ffddd1-4e2b-45d9-9b36-bb730167ec8016
2570405OLANZapine 20 MG / samidorphan 10 MG Oral TabletPSN32ffddd1-4e2b-45d9-9b36-bb730167ec8016
2570392OLANZapine 5 MG / samidorphan 10 MG Oral TabletPSN32ffddd1-4e2b-45d9-9b36-bb730167ec8016
2570401olanzapine 10 MG / samidorphan 10 MG Oral Tablet [Lybalvi]SBD32ffddd1-4e2b-45d9-9b36-bb730167ec8016
2570404olanzapine 15 MG / samidorphan 10 MG Oral Tablet [Lybalvi]SBD32ffddd1-4e2b-45d9-9b36-bb730167ec8016
2570407olanzapine 20 MG / samidorphan 10 MG Oral Tablet [Lybalvi]SBD32ffddd1-4e2b-45d9-9b36-bb730167ec8016
2570398olanzapine 5 MG / samidorphan 10 MG Oral Tablet [Lybalvi]SBD32ffddd1-4e2b-45d9-9b36-bb730167ec8016
2570399olanzapine 10 MG / samidorphan 10 MG Oral TabletSCD32ffddd1-4e2b-45d9-9b36-bb730167ec8016
2570402olanzapine 15 MG / samidorphan 10 MG Oral TabletSCD32ffddd1-4e2b-45d9-9b36-bb730167ec8016
2570405olanzapine 20 MG / samidorphan 10 MG Oral TabletSCD32ffddd1-4e2b-45d9-9b36-bb730167ec8016
2570392olanzapine 5 MG / samidorphan 10 MG Oral TabletSCD32ffddd1-4e2b-45d9-9b36-bb730167ec8016
2570401Lybalvi (olanzapine 10 MG / samidorphan 10 MG (as samidorphan L-malate 13.6 MG)) Oral TabletSY32ffddd1-4e2b-45d9-9b36-bb730167ec8016
2570401Lybalvi (olanzapine 10 MG / samidorphan 10 MG) Oral TabletSY32ffddd1-4e2b-45d9-9b36-bb730167ec8016
2570404Lybalvi (olanzapine 15 MG / samidorphan 10 MG (as samidorphan L-malate 13.6 MG)) Oral TabletSY32ffddd1-4e2b-45d9-9b36-bb730167ec8016
2570404Lybalvi (olanzapine 15 MG / samidorphan 10 MG) Oral TabletSY32ffddd1-4e2b-45d9-9b36-bb730167ec8016
2570407Lybalvi (olanzapine 20 MG / samidorphan 10 MG (as samidorphan L-malate 13.6 MG)) Oral TabletSY32ffddd1-4e2b-45d9-9b36-bb730167ec8016
2570407Lybalvi (olanzapine 20 MG / samidorphan 10 MG) Oral TabletSY32ffddd1-4e2b-45d9-9b36-bb730167ec8016
2570398Lybalvi (olanzapine 5 MG / samidorphan 10 MG (as samidorphan L-malate 13.6 MG)) Oral TabletSY32ffddd1-4e2b-45d9-9b36-bb730167ec8016
2570398Lybalvi (olanzapine 5 MG / samidorphan 10 MG) Oral TabletSY32ffddd1-4e2b-45d9-9b36-bb730167ec8016
2570399olanzapine 10 MG / samidorphan 10 MG (as samidorphan L-malate 13.6 MG) Oral TabletSY32ffddd1-4e2b-45d9-9b36-bb730167ec8016
2570402olanzapine 15 MG / samidorphan 10 MG (as samidorphan L-malate 13.6 MG) Oral TabletSY32ffddd1-4e2b-45d9-9b36-bb730167ec8016
2570405olanzapine 20 MG / samidorphan 10 MG (as samidorphan L-malate 13.6 MG) Oral TabletSY32ffddd1-4e2b-45d9-9b36-bb730167ec8016
2570392olanzapine 5 MG / samidorphan 10 MG (as samidorphan L-malate 13.6 MG) Oral TabletSY32ffddd1-4e2b-45d9-9b36-bb730167ec8016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65757-654-0465757065404128205 TABLET, FILM COATED in 1 CONTAINER (65757-654-04)28-MAY-21Current
65757-654-40657570654401 BOTTLE in 1 CARTON (65757-654-40) > 7 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-09-200000-00-00NoNoCurrent
65757-654-41657570654411 BOTTLE in 1 CARTON (65757-654-41) / 7 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-09-200000-00-00YesNoCurrent
65757-654-42657570654421 BOTTLE in 1 CARTON (65757-654-42) / 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-09-200000-00-00NoNoCurrent
65757-654-44657570654441 BOTTLE in 1 CARTON (65757-654-44) > 90 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-09-200000-00-00NoNoCurrent