FDA.reportPublic FDA data

LYBALVI

Product NDC
65757-652
Requested package NDC
65757-652-02
11-digit product format
657570652
Labeler code
65757
Product ID
65757-652_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
10; 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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
unfinished packagepackage65757-65265757-652-02UNFINISHEDActive or certified unfinished drug listing2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 21:27 UTC · source 2025-12-05a6255e0c9aa5…a0211a219f2e…
2025-08-26 23:59 UTC · source 2025-08-261d862106b807…00c93037cd84…
2025-05-15 14:59 UTC · source 2025-05-14390b4c401c3f…2c692c2daee3…
2025-04-01 07:37 UTC · source 2025-03-31e30019b0c005…a3f0b14938b7…
2025-03-01 13:19 UTC · source 2025-02-28bbbc9f937eca…946b9c97cf81…
2025-02-27 05:24 UTC · source 2025-02-26f268b84574a6…26285f5ac5df…
2025-02-01 13:13 UTC · source 2025-01-31f764e8902f78…92046438deef…
2025-01-20 13:05 UTC · source 2025-01-1768b1e3bced9e…98a755eb8bc6…
2024-11-29 20:42 UTC · source 2024-11-2905c55d027831…ca05dca9dc4c…
2024-11-09 02:36 UTC · source 2024-11-0848b4f40e6753…c7c7a00d2afa…
2024-10-09 02:27 UTC · source 2024-10-0827f29a85d7e4…1372111e901f…
2024-07-10 04:00 UTC · source 2024-07-098d62ce987f31…9fe9ef23e30d…
2024-05-28 21:11 UTC · source 2024-05-28d1e113ab4d42…063ee3eb0a1d…
2024-05-15 03:51 UTC · source 2024-05-1450b4072663b7…eae3003ed65e…
2022-04-09 23:13 UTC · source 2022-04-08906f6e251498…bf70b80e44f0…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N213378-001LYBALVIOLANZAPINE; SAMIDORPHAN L-MALATE5MG;EQ 10MG BASETABLET / ORALRLD, RS2021-05-28
N213378-002LYBALVIOLANZAPINE; SAMIDORPHAN L-MALATE10MG;EQ 10MG BASETABLET / ORALRLD2021-05-28
N213378-003LYBALVIOLANZAPINE; SAMIDORPHAN L-MALATE15MG;EQ 10MG BASETABLET / ORALRLD2021-05-28
N213378-004LYBALVIOLANZAPINE; SAMIDORPHAN L-MALATE20MG;EQ 10MG BASETABLET / ORALRLD2021-05-28

Orange Book patents#

Current patent rows page 1 of 2 · 84 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N213378-001107167852031-08-23U-31362021-06-25
N213378-001107167852031-08-23U-31372021-06-25
N213378-001111855412031-08-23U-31402021-12-22
N213378-001112414252031-08-23U-31372022-03-03
N213378-001113511662031-08-23U-31402022-07-11
N213378-001113511662031-08-23U-31412022-07-11
N213378-001117938052031-08-23U-37342023-11-13
N213378-001121940352031-08-23U-31412025-01-31
N213378-00191269772031-08-23U-3136Drug product2021-06-25
N213378-00191269772031-08-23U-3137Drug product2021-06-25
N213378-00195172352031-08-23U-31382021-06-25
N213378-00195172352031-08-23U-31392021-06-25
N213378-00191198482031-08-30Drug substance2021-06-25
N213378-00187789602032-02-13U-31362021-06-25
N213378-00187789602032-02-13U-31372021-06-25
N213378-001103000542033-05-31U-3140Drug product2021-06-25
N213378-001103000542033-05-31U-3141Drug product2021-06-25
N213378-001117074662041-11-12Drug product2023-08-23
N213378-001119511112041-11-12U-38862024-04-24
N213378-001119511112041-11-12U-38872024-04-24
N213378-001123904742041-11-12Drug product2025-08-19
N213378-002107167852031-08-23U-31362021-06-25
N213378-002107167852031-08-23U-31372021-06-25
N213378-002111855412031-08-23U-31402021-12-22
N213378-002112414252031-08-23U-31372022-03-03
N213378-002113511662031-08-23U-31402022-07-11
N213378-002113511662031-08-23U-31412022-07-11
N213378-002117938052031-08-23U-37342023-11-13
N213378-002121940352031-08-23U-31412025-01-31
N213378-00291269772031-08-23U-3136Drug product2021-06-25
N213378-00291269772031-08-23U-3137Drug product2021-06-25
N213378-00295172352031-08-23U-31382021-06-25
N213378-00295172352031-08-23U-31392021-06-25
N213378-00291198482031-08-30Drug substance2021-06-25
N213378-00287789602032-02-13U-31362021-06-25
N213378-00287789602032-02-13U-31372021-06-25
N213378-002103000542033-05-31U-3140Drug product2021-06-25
N213378-002103000542033-05-31U-3141Drug product2021-06-25
N213378-002117074662041-11-12Drug product2023-08-23
N213378-002119511112041-11-12U-38862024-04-24
N213378-002119511112041-11-12U-38872024-04-24
N213378-002123904742041-11-12Drug product2025-08-19
N213378-003107167852031-08-23U-31362021-06-25
N213378-003107167852031-08-23U-31372021-06-25
N213378-003111855412031-08-23U-31402021-12-22
N213378-003112414252031-08-23U-31372022-03-03
N213378-003113511662031-08-23U-31402022-07-11
N213378-003113511662031-08-23U-31412022-07-11
N213378-003117938052031-08-23U-37342023-11-13
N213378-003121940352031-08-23U-31412025-01-31
N213378-00391269772031-08-23U-3136Drug product2021-06-25
N213378-00391269772031-08-23U-3137Drug product2021-06-25
N213378-00395172352031-08-23U-31382021-06-25
N213378-00395172352031-08-23U-31392021-06-25
N213378-00391198482031-08-30Drug substance2021-06-25
N213378-00387789602032-02-13U-31362021-06-25
N213378-00387789602032-02-13U-31372021-06-25
N213378-003103000542033-05-31U-3140Drug product2021-06-25
N213378-003103000542033-05-31U-3141Drug product2021-06-25
N213378-003117074662041-11-12Drug product2023-08-23
N213378-003119511112041-11-12U-38862024-04-24
N213378-003119511112041-11-12U-38872024-04-24
N213378-003123904742041-11-12Drug product2025-08-19
N213378-004107167852031-08-23U-31362021-06-25
N213378-004107167852031-08-23U-31372021-06-25
N213378-004111855412031-08-23U-31402021-12-22
N213378-004112414252031-08-23U-31372022-03-03
N213378-004113511662031-08-23U-31402022-07-11
N213378-004113511662031-08-23U-31412022-07-11
N213378-004117938052031-08-23U-37342023-11-13
N213378-004121940352031-08-23U-31412025-01-31
N213378-00491269772031-08-23U-3136Drug product2021-06-25
N213378-00491269772031-08-23U-3137Drug product2021-06-25
N213378-00495172352031-08-23U-31382021-06-25
N213378-00495172352031-08-23U-31392021-06-25
N213378-00491198482031-08-30Drug substance2021-06-25
N213378-00487789602032-02-13U-31362021-06-25
N213378-00487789602032-02-13U-31372021-06-25
N213378-004103000542033-05-31U-3140Drug product2021-06-25
N213378-004103000542033-05-31U-3141Drug product2021-06-25

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 4 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N213378-001NCE2026-05-28
N213378-002NCE2026-05-28
N213378-003NCE2026-05-28
N213378-004NCE2026-05-28

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 136 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N213378-001LYBALVI5MG;EQ 10MG BASETABLET / ORALRLD, RS2021-05-28caaa826d4ba7…
2026-08-18 06:07:402026-07N213378-002LYBALVI10MG;EQ 10MG BASETABLET / ORALRLD2021-05-28caaa826d4ba7…
2026-08-18 06:07:402026-07N213378-003LYBALVI15MG;EQ 10MG BASETABLET / ORALRLD2021-05-28caaa826d4ba7…
2026-08-18 06:07:402026-07N213378-004LYBALVI20MG;EQ 10MG BASETABLET / ORALRLD2021-05-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N213378-001LYBALVI5MG;EQ 10MG BASETABLET / ORALRLD, RS2021-05-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213378-002LYBALVI10MG;EQ 10MG BASETABLET / ORALRLD2021-05-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213378-003LYBALVI15MG;EQ 10MG BASETABLET / ORALRLD2021-05-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213378-004LYBALVI20MG;EQ 10MG BASETABLET / ORALRLD2021-05-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213378-001LYBALVI5MG;EQ 10MG BASETABLET / ORALRLD, RS2021-05-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213378-002LYBALVI10MG;EQ 10MG BASETABLET / ORALRLD2021-05-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213378-003LYBALVI15MG;EQ 10MG BASETABLET / ORALRLD2021-05-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213378-004LYBALVI20MG;EQ 10MG BASETABLET / ORALRLD2021-05-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N213378-001LYBALVI5MG;EQ 10MG BASETABLET / ORALRLD, RS2021-05-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213378-002LYBALVI10MG;EQ 10MG BASETABLET / ORALRLD2021-05-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213378-003LYBALVI15MG;EQ 10MG BASETABLET / ORALRLD2021-05-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213378-004LYBALVI20MG;EQ 10MG BASETABLET / ORALRLD2021-05-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N213378-001LYBALVI5MG;EQ 10MG BASETABLET / ORALRLD, RS2021-05-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N213378-002LYBALVI10MG;EQ 10MG BASETABLET / ORALRLD2021-05-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N213378-003LYBALVI15MG;EQ 10MG BASETABLET / ORALRLD2021-05-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N213378-004LYBALVI20MG;EQ 10MG BASETABLET / ORALRLD2021-05-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N213378-001LYBALVI5MG;EQ 10MG BASETABLET / ORALRLD, RS2021-05-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N213378-002LYBALVI10MG;EQ 10MG BASETABLET / ORALRLD2021-05-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N213378-003LYBALVI15MG;EQ 10MG BASETABLET / ORALRLD2021-05-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N213378-004LYBALVI20MG;EQ 10MG BASETABLET / ORALRLD2021-05-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N213378-001LYBALVI5MG;EQ 10MG BASETABLET / ORALRLD, RS2021-05-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N213378-002LYBALVI10MG;EQ 10MG BASETABLET / ORALRLD2021-05-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N213378-003LYBALVI15MG;EQ 10MG BASETABLET / ORALRLD2021-05-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N213378-004LYBALVI20MG;EQ 10MG BASETABLET / ORALRLD2021-05-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N213378-001LYBALVI5MG;EQ 10MG BASETABLET / ORALRLD, RS2021-05-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N213378-002LYBALVI10MG;EQ 10MG BASETABLET / ORALRLD2021-05-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N213378-003LYBALVI15MG;EQ 10MG BASETABLET / ORALRLD2021-05-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N213378-004LYBALVI20MG;EQ 10MG BASETABLET / ORALRLD2021-05-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N213378-001LYBALVI5MG;EQ 10MG BASETABLET / ORALRLD, RS2021-05-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N213378-002LYBALVI10MG;EQ 10MG BASETABLET / ORALRLD2021-05-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N213378-003LYBALVI15MG;EQ 10MG BASETABLET / ORALRLD2021-05-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N213378-004LYBALVI20MG;EQ 10MG BASETABLET / ORALRLD2021-05-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N213378-001LYBALVI5MG;EQ 10MG BASETABLET / ORALRLD, RS2021-05-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N213378-002LYBALVI10MG;EQ 10MG BASETABLET / ORALRLD2021-05-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N213378-003LYBALVI15MG;EQ 10MG BASETABLET / ORALRLD2021-05-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N213378-004LYBALVI20MG;EQ 10MG BASETABLET / ORALRLD2021-05-28d8e5a09893c0…

Observed Orange Book patent history#

Patent history page 1 of 62 · 2,444 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N213378-001107167852031-08-23U-31362021-06-25caaa826d4ba7…
2026-08-18 06:07:402026-07N213378-001107167852031-08-23U-31372021-06-25caaa826d4ba7…
2026-08-18 06:07:402026-07N213378-001111855412031-08-23U-31402021-12-22caaa826d4ba7…
2026-08-18 06:07:402026-07N213378-001112414252031-08-23U-31372022-03-03caaa826d4ba7…
2026-08-18 06:07:402026-07N213378-001113511662031-08-23U-31402022-07-11caaa826d4ba7…
2026-08-18 06:07:402026-07N213378-001113511662031-08-23U-31412022-07-11caaa826d4ba7…
2026-08-18 06:07:402026-07N213378-001117938052031-08-23U-37342023-11-13caaa826d4ba7…
2026-08-18 06:07:402026-07N213378-001121940352031-08-23U-31412025-01-31caaa826d4ba7…
2026-08-18 06:07:402026-07N213378-00191269772031-08-23U-3136Drug product2021-06-25caaa826d4ba7…
2026-08-18 06:07:402026-07N213378-00191269772031-08-23U-3137Drug product2021-06-25caaa826d4ba7…
2026-08-18 06:07:402026-07N213378-00195172352031-08-23U-31392021-06-25caaa826d4ba7…
2026-08-18 06:07:402026-07N213378-00195172352031-08-23U-31382021-06-25caaa826d4ba7…
2026-08-18 06:07:402026-07N213378-00191198482031-08-30Drug substance2021-06-25caaa826d4ba7…
2026-08-18 06:07:402026-07N213378-00187789602032-02-13U-31362021-06-25caaa826d4ba7…
2026-08-18 06:07:402026-07N213378-00187789602032-02-13U-31372021-06-25caaa826d4ba7…
2026-08-18 06:07:402026-07N213378-001103000542033-05-31U-3140Drug product2021-06-25caaa826d4ba7…
2026-08-18 06:07:402026-07N213378-001103000542033-05-31U-3141Drug product2021-06-25caaa826d4ba7…
2026-08-18 06:07:402026-07N213378-001117074662041-11-12Drug product2023-08-23caaa826d4ba7…
2026-08-18 06:07:402026-07N213378-001119511112041-11-12U-38862024-04-24caaa826d4ba7…
2026-08-18 06:07:402026-07N213378-001119511112041-11-12U-38872024-04-24caaa826d4ba7…
2026-08-18 06:07:402026-07N213378-001123904742041-11-12Drug product2025-08-19caaa826d4ba7…
2026-08-18 06:07:402026-07N213378-002107167852031-08-23U-31372021-06-25caaa826d4ba7…
2026-08-18 06:07:402026-07N213378-002107167852031-08-23U-31362021-06-25caaa826d4ba7…
2026-08-18 06:07:402026-07N213378-002111855412031-08-23U-31402021-12-22caaa826d4ba7…
2026-08-18 06:07:402026-07N213378-002112414252031-08-23U-31372022-03-03caaa826d4ba7…
2026-08-18 06:07:402026-07N213378-002113511662031-08-23U-31402022-07-11caaa826d4ba7…
2026-08-18 06:07:402026-07N213378-002113511662031-08-23U-31412022-07-11caaa826d4ba7…
2026-08-18 06:07:402026-07N213378-002117938052031-08-23U-37342023-11-13caaa826d4ba7…
2026-08-18 06:07:402026-07N213378-002121940352031-08-23U-31412025-01-31caaa826d4ba7…
2026-08-18 06:07:402026-07N213378-00291269772031-08-23U-3137Drug product2021-06-25caaa826d4ba7…
2026-08-18 06:07:402026-07N213378-00291269772031-08-23U-3136Drug product2021-06-25caaa826d4ba7…
2026-08-18 06:07:402026-07N213378-00295172352031-08-23U-31382021-06-25caaa826d4ba7…
2026-08-18 06:07:402026-07N213378-00295172352031-08-23U-31392021-06-25caaa826d4ba7…
2026-08-18 06:07:402026-07N213378-00291198482031-08-30Drug substance2021-06-25caaa826d4ba7…
2026-08-18 06:07:402026-07N213378-00287789602032-02-13U-31362021-06-25caaa826d4ba7…
2026-08-18 06:07:402026-07N213378-00287789602032-02-13U-31372021-06-25caaa826d4ba7…
2026-08-18 06:07:402026-07N213378-002103000542033-05-31U-3141Drug product2021-06-25caaa826d4ba7…
2026-08-18 06:07:402026-07N213378-002103000542033-05-31U-3140Drug product2021-06-25caaa826d4ba7…
2026-08-18 06:07:402026-07N213378-002117074662041-11-12Drug product2023-08-23caaa826d4ba7…
2026-08-18 06:07:402026-07N213378-002119511112041-11-12U-38862024-04-24caaa826d4ba7…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 136 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-08-18 06:07:402026-07N213378-001NCE2026-05-28caaa826d4ba7…
2026-08-18 06:07:402026-07N213378-002NCE2026-05-28caaa826d4ba7…
2026-08-18 06:07:402026-07N213378-003NCE2026-05-28caaa826d4ba7…
2026-08-18 06:07:402026-07N213378-004NCE2026-05-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N213378-001NCE2026-05-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213378-002NCE2026-05-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213378-003NCE2026-05-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213378-004NCE2026-05-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213378-001NCE2026-05-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213378-002NCE2026-05-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213378-003NCE2026-05-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213378-004NCE2026-05-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N213378-001NCE2026-05-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213378-002NCE2026-05-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213378-003NCE2026-05-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213378-004NCE2026-05-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N213378-001NCE2026-05-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N213378-002NCE2026-05-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N213378-003NCE2026-05-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N213378-004NCE2026-05-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N213378-001NCE2026-05-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N213378-002NCE2026-05-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N213378-003NCE2026-05-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N213378-004NCE2026-05-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N213378-001NCE2026-05-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N213378-002NCE2026-05-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N213378-003NCE2026-05-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N213378-004NCE2026-05-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N213378-001NCE2026-05-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N213378-002NCE2026-05-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N213378-003NCE2026-05-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N213378-004NCE2026-05-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N213378-001NCE2026-05-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N213378-002NCE2026-05-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N213378-003NCE2026-05-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N213378-004NCE2026-05-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N213378-001NCE2026-05-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N213378-002NCE2026-05-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N213378-003NCE2026-05-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N213378-004NCE2026-05-28d8e5a09893c0…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OLANZAPINE10 mg/1
SAMIDORPHAN L-MALATE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0AJQ5N56E0Internal UNII lookup
N7U69T4SZRInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2570392Internal RxNorm lookup
2570398Internal RxNorm lookup
2570399Internal RxNorm lookup
2570401Internal RxNorm lookup
2570402Internal RxNorm lookup
2570404Internal RxNorm lookup
2570405Internal RxNorm lookup
2570407Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
32ffddd1-4e2b-45d9-9b36-bb730167ec80Available on FDA.report

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
65757-652-40LYBALVI1 in 1 CARTONTABLET, FILM COATED116
65757-652-40LYBALVI7 in 1 BOTTLETABLET, FILM COATED716
65757-652-41LYBALVI7 in 1 BOTTLETABLET, FILM COATED716
65757-652-41LYBALVI1 in 1 CARTONTABLET, FILM COATED116
65757-652-42LYBALVI30 in 1 BOTTLETABLET, FILM COATED3016
65757-652-42LYBALVI1 in 1 CARTONTABLET, FILM COATED116
65757-652-44LYBALVI1 in 1 CARTONTABLET, FILM COATED116
65757-652-44LYBALVI90 in 1 BOTTLETABLET, FILM COATED9016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65757-652-40EA - Each65757-65295c1c07d-ccc0-43c0-a44f-d874e53438df12023-12-05
65757-652-42EA - Each65757-6525185978f-9a8e-474f-8732-6496b8539c1112021-10-08
65757-652-44EA - Each65757-652ede17792-3831-42f6-9cd5-b228524c2c8912021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65757-652LYBALVI (OLANZAPINE AND SAMIDORPHAN L-MALATE) TABLET, FILM COATED [ALKERMES, INC.]13Current NDC, Legacy NDC, 8 package rows20250316_32ffddd1-4e2b-45d9-9b36-bb730167ec80.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LYBALVIOLANZAPINE AND SAMIDORPHAN L-MALATEAlkermes, Inc.32ffddd1-4e2b-45d9-9b36-bb730167ec802026-01-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 213378
application number: NDA213378
ndc (product): 65757-652

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 formatDescriptionMarketing startStatus
65757-652-0265757065202192308 TABLET, FILM COATED in 1 CONTAINER (65757-652-02)28-MAY-21Current