LYBALVI

Product NDC: 65757-653
11-digit product format: 657570653
Labeler code: 65757
Product ID: 65757-653_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: 15; 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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
unfinished product	product	65757-653		UNFINISHED	Active or certified unfinished drug listing	2026-08-17
unfinished package	package	65757-653	65757-653-03	UNFINISHED	Active or certified unfinished drug listing	2026-08-17
excluded package	package	65757-653	65757-653-40	D	Discontinued by firm	2026-08-17
excluded package	package	65757-653	65757-653-44	D	Discontinued by firm	2026-08-17

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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 21:27 UTC · source 2025-12-05	unfinished product	product		`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 21:27 UTC · source 2025-12-05	unfinished package	package	65757-653-03	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished product	product		`1d862106b807…`	`00c93037cd84…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished package	package	65757-653-03	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished product	product		`390b4c401c3f…`	`2c692c2daee3…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished package	package	65757-653-03	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished product	product		`e30019b0c005…`	`a3f0b14938b7…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished package	package	65757-653-03	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished product	product		`bbbc9f937eca…`	`946b9c97cf81…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished package	package	65757-653-03	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished product	product		`f268b84574a6…`	`26285f5ac5df…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished package	package	65757-653-03	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished product	product		`f764e8902f78…`	`92046438deef…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished package	package	65757-653-03	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished product	product		`68b1e3bced9e…`	`98a755eb8bc6…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished package	package	65757-653-03	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished product	product		`05c55d027831…`	`ca05dca9dc4c…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished package	package	65757-653-03	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished product	product		`48b4f40e6753…`	`c7c7a00d2afa…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished package	package	65757-653-03	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished product	product		`27f29a85d7e4…`	`1372111e901f…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished package	package	65757-653-03	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished product	product		`8d62ce987f31…`	`9fe9ef23e30d…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished package	package	65757-653-03	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished product	product		`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished package	package	65757-653-03	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished product	product		`50b4072663b7…`	`eae3003ed65e…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished package	package	65757-653-03	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished product	product		`906f6e251498…`	`bf70b80e44f0…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished package	package	65757-653-03	`906f6e251498…`	`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-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N213378-001	LYBALVI	OLANZAPINE; SAMIDORPHAN L-MALATE	5MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2021-05-28
N213378-002	LYBALVI	OLANZAPINE; SAMIDORPHAN L-MALATE	10MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-05-28
N213378-003	LYBALVI	OLANZAPINE; SAMIDORPHAN L-MALATE	15MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-05-28
N213378-004	LYBALVI	OLANZAPINE; SAMIDORPHAN L-MALATE	20MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-05-28

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N213378-001	10716785	2031-08-23	U-3136		2021-06-25
N213378-001	10716785	2031-08-23	U-3137		2021-06-25
N213378-001	11185541	2031-08-23	U-3140		2021-12-22
N213378-001	11241425	2031-08-23	U-3137		2022-03-03
N213378-001	11351166	2031-08-23	U-3140		2022-07-11
N213378-001	11351166	2031-08-23	U-3141		2022-07-11
N213378-001	11793805	2031-08-23	U-3734		2023-11-13
N213378-001	12194035	2031-08-23	U-3141		2025-01-31
N213378-001	9126977	2031-08-23	U-3136	Drug product	2021-06-25
N213378-001	9126977	2031-08-23	U-3137	Drug product	2021-06-25
N213378-001	9517235	2031-08-23	U-3138		2021-06-25
N213378-001	9517235	2031-08-23	U-3139		2021-06-25
N213378-001	9119848	2031-08-30		Drug substance	2021-06-25
N213378-001	8778960	2032-02-13	U-3136		2021-06-25
N213378-001	8778960	2032-02-13	U-3137		2021-06-25
N213378-001	10300054	2033-05-31	U-3140	Drug product	2021-06-25
N213378-001	10300054	2033-05-31	U-3141	Drug product	2021-06-25
N213378-001	11707466	2041-11-12		Drug product	2023-08-23
N213378-001	11951111	2041-11-12	U-3886		2024-04-24
N213378-001	11951111	2041-11-12	U-3887		2024-04-24
N213378-001	12390474	2041-11-12		Drug product	2025-08-19
N213378-002	10716785	2031-08-23	U-3136		2021-06-25
N213378-002	10716785	2031-08-23	U-3137		2021-06-25
N213378-002	11185541	2031-08-23	U-3140		2021-12-22
N213378-002	11241425	2031-08-23	U-3137		2022-03-03
N213378-002	11351166	2031-08-23	U-3140		2022-07-11
N213378-002	11351166	2031-08-23	U-3141		2022-07-11
N213378-002	11793805	2031-08-23	U-3734		2023-11-13
N213378-002	12194035	2031-08-23	U-3141		2025-01-31
N213378-002	9126977	2031-08-23	U-3136	Drug product	2021-06-25
N213378-002	9126977	2031-08-23	U-3137	Drug product	2021-06-25
N213378-002	9517235	2031-08-23	U-3138		2021-06-25
N213378-002	9517235	2031-08-23	U-3139		2021-06-25
N213378-002	9119848	2031-08-30		Drug substance	2021-06-25
N213378-002	8778960	2032-02-13	U-3136		2021-06-25
N213378-002	8778960	2032-02-13	U-3137		2021-06-25
N213378-002	10300054	2033-05-31	U-3140	Drug product	2021-06-25
N213378-002	10300054	2033-05-31	U-3141	Drug product	2021-06-25
N213378-002	11707466	2041-11-12		Drug product	2023-08-23
N213378-002	11951111	2041-11-12	U-3886		2024-04-24
N213378-002	11951111	2041-11-12	U-3887		2024-04-24
N213378-002	12390474	2041-11-12		Drug product	2025-08-19
N213378-003	10716785	2031-08-23	U-3136		2021-06-25
N213378-003	10716785	2031-08-23	U-3137		2021-06-25
N213378-003	11185541	2031-08-23	U-3140		2021-12-22
N213378-003	11241425	2031-08-23	U-3137		2022-03-03
N213378-003	11351166	2031-08-23	U-3140		2022-07-11
N213378-003	11351166	2031-08-23	U-3141		2022-07-11
N213378-003	11793805	2031-08-23	U-3734		2023-11-13
N213378-003	12194035	2031-08-23	U-3141		2025-01-31
N213378-003	9126977	2031-08-23	U-3136	Drug product	2021-06-25
N213378-003	9126977	2031-08-23	U-3137	Drug product	2021-06-25
N213378-003	9517235	2031-08-23	U-3138		2021-06-25
N213378-003	9517235	2031-08-23	U-3139		2021-06-25
N213378-003	9119848	2031-08-30		Drug substance	2021-06-25
N213378-003	8778960	2032-02-13	U-3136		2021-06-25
N213378-003	8778960	2032-02-13	U-3137		2021-06-25
N213378-003	10300054	2033-05-31	U-3140	Drug product	2021-06-25
N213378-003	10300054	2033-05-31	U-3141	Drug product	2021-06-25
N213378-003	11707466	2041-11-12		Drug product	2023-08-23
N213378-003	11951111	2041-11-12	U-3886		2024-04-24
N213378-003	11951111	2041-11-12	U-3887		2024-04-24
N213378-003	12390474	2041-11-12		Drug product	2025-08-19
N213378-004	10716785	2031-08-23	U-3136		2021-06-25
N213378-004	10716785	2031-08-23	U-3137		2021-06-25
N213378-004	11185541	2031-08-23	U-3140		2021-12-22
N213378-004	11241425	2031-08-23	U-3137		2022-03-03
N213378-004	11351166	2031-08-23	U-3140		2022-07-11
N213378-004	11351166	2031-08-23	U-3141		2022-07-11
N213378-004	11793805	2031-08-23	U-3734		2023-11-13
N213378-004	12194035	2031-08-23	U-3141		2025-01-31
N213378-004	9126977	2031-08-23	U-3136	Drug product	2021-06-25
N213378-004	9126977	2031-08-23	U-3137	Drug product	2021-06-25
N213378-004	9517235	2031-08-23	U-3138		2021-06-25
N213378-004	9517235	2031-08-23	U-3139		2021-06-25
N213378-004	9119848	2031-08-30		Drug substance	2021-06-25
N213378-004	8778960	2032-02-13	U-3136		2021-06-25
N213378-004	8778960	2032-02-13	U-3137		2021-06-25
N213378-004	10300054	2033-05-31	U-3140	Drug product	2021-06-25
N213378-004	10300054	2033-05-31	U-3141	Drug product	2021-06-25

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N213378-001	NCE	2026-05-28
N213378-002	NCE	2026-05-28
N213378-003	NCE	2026-05-28
N213378-004	NCE	2026-05-28

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N213378-001	LYBALVI	5MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2021-05-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-002	LYBALVI	10MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-05-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-003	LYBALVI	15MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-05-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-004	LYBALVI	20MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-05-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N213378-001	LYBALVI	5MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2021-05-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213378-002	LYBALVI	10MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-05-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213378-003	LYBALVI	15MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-05-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213378-004	LYBALVI	20MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-05-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213378-001	LYBALVI	5MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2021-05-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213378-002	LYBALVI	10MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-05-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213378-003	LYBALVI	15MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-05-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213378-004	LYBALVI	20MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-05-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213378-001	LYBALVI	5MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2021-05-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213378-002	LYBALVI	10MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-05-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213378-003	LYBALVI	15MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-05-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213378-004	LYBALVI	20MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-05-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213378-001	LYBALVI	5MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2021-05-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213378-002	LYBALVI	10MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-05-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213378-003	LYBALVI	15MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-05-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213378-004	LYBALVI	20MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-05-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213378-001	LYBALVI	5MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2021-05-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213378-002	LYBALVI	10MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-05-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213378-003	LYBALVI	15MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-05-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213378-004	LYBALVI	20MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-05-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213378-001	LYBALVI	5MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2021-05-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213378-002	LYBALVI	10MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-05-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213378-003	LYBALVI	15MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-05-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213378-004	LYBALVI	20MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-05-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213378-001	LYBALVI	5MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2021-05-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213378-002	LYBALVI	10MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-05-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213378-003	LYBALVI	15MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-05-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213378-004	LYBALVI	20MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-05-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213378-001	LYBALVI	5MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2021-05-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213378-002	LYBALVI	10MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-05-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213378-003	LYBALVI	15MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-05-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213378-004	LYBALVI	20MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-05-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213378-001	LYBALVI	5MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2021-05-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213378-002	LYBALVI	10MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-05-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213378-003	LYBALVI	15MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-05-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213378-004	LYBALVI	20MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-05-28	`d8e5a09893c0…`

Observed Orange Book patent history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N213378-001	10716785	2031-08-23	U-3136		2021-06-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-001	10716785	2031-08-23	U-3137		2021-06-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-001	11185541	2031-08-23	U-3140		2021-12-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-001	11241425	2031-08-23	U-3137		2022-03-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-001	11351166	2031-08-23	U-3140		2022-07-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-001	11351166	2031-08-23	U-3141		2022-07-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-001	11793805	2031-08-23	U-3734		2023-11-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-001	12194035	2031-08-23	U-3141		2025-01-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-001	9126977	2031-08-23	U-3136	Drug product	2021-06-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-001	9126977	2031-08-23	U-3137	Drug product	2021-06-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-001	9517235	2031-08-23	U-3139		2021-06-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-001	9517235	2031-08-23	U-3138		2021-06-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-001	9119848	2031-08-30		Drug substance	2021-06-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-001	8778960	2032-02-13	U-3136		2021-06-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-001	8778960	2032-02-13	U-3137		2021-06-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-001	10300054	2033-05-31	U-3140	Drug product	2021-06-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-001	10300054	2033-05-31	U-3141	Drug product	2021-06-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-001	11707466	2041-11-12		Drug product	2023-08-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-001	11951111	2041-11-12	U-3886		2024-04-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-001	11951111	2041-11-12	U-3887		2024-04-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-001	12390474	2041-11-12		Drug product	2025-08-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-002	10716785	2031-08-23	U-3137		2021-06-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-002	10716785	2031-08-23	U-3136		2021-06-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-002	11185541	2031-08-23	U-3140		2021-12-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-002	11241425	2031-08-23	U-3137		2022-03-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-002	11351166	2031-08-23	U-3140		2022-07-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-002	11351166	2031-08-23	U-3141		2022-07-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-002	11793805	2031-08-23	U-3734		2023-11-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-002	12194035	2031-08-23	U-3141		2025-01-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-002	9126977	2031-08-23	U-3137	Drug product	2021-06-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-002	9126977	2031-08-23	U-3136	Drug product	2021-06-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-002	9517235	2031-08-23	U-3138		2021-06-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-002	9517235	2031-08-23	U-3139		2021-06-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-002	9119848	2031-08-30		Drug substance	2021-06-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-002	8778960	2032-02-13	U-3136		2021-06-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-002	8778960	2032-02-13	U-3137		2021-06-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-002	10300054	2033-05-31	U-3141	Drug product	2021-06-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-002	10300054	2033-05-31	U-3140	Drug product	2021-06-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-002	11707466	2041-11-12		Drug product	2023-08-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-002	11951111	2041-11-12	U-3886		2024-04-24	`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 136 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N213378-001	NCE	2026-05-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-002	NCE	2026-05-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-003	NCE	2026-05-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-004	NCE	2026-05-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N213378-001	NCE	2026-05-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213378-002	NCE	2026-05-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213378-003	NCE	2026-05-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213378-004	NCE	2026-05-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213378-001	NCE	2026-05-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213378-002	NCE	2026-05-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213378-003	NCE	2026-05-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213378-004	NCE	2026-05-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213378-001	NCE	2026-05-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213378-002	NCE	2026-05-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213378-003	NCE	2026-05-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213378-004	NCE	2026-05-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213378-001	NCE	2026-05-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213378-002	NCE	2026-05-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213378-003	NCE	2026-05-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213378-004	NCE	2026-05-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213378-001	NCE	2026-05-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213378-002	NCE	2026-05-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213378-003	NCE	2026-05-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213378-004	NCE	2026-05-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213378-001	NCE	2026-05-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213378-002	NCE	2026-05-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213378-003	NCE	2026-05-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213378-004	NCE	2026-05-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213378-001	NCE	2026-05-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213378-002	NCE	2026-05-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213378-003	NCE	2026-05-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213378-004	NCE	2026-05-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213378-001	NCE	2026-05-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213378-002	NCE	2026-05-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213378-003	NCE	2026-05-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213378-004	NCE	2026-05-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213378-001	NCE	2026-05-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213378-002	NCE	2026-05-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213378-003	NCE	2026-05-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213378-004	NCE	2026-05-28	`d8e5a09893c0…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OLANZAPINE	15 mg/1
SAMIDORPHAN L-MALATE	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0AJQ5N56E0	Internal UNII lookup
N7U69T4SZR	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
32ffddd1-4e2b-45d9-9b36-bb730167ec80	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
42e9462d-db65-453b-8069-8fb2df9182e8	Product name	1	20211216
12d02c27-e8da-47f1-b815-ccca982731ef	Product name	9	20170802
877783eb-030c-6e3f-0979-804cf94d8856	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
65757-653-40	LYBALVI	1 in 1 CARTON	TABLET, FILM COATED	1	16
65757-653-40	LYBALVI	7 in 1 BOTTLE	TABLET, FILM COATED	7	16
65757-653-41	LYBALVI	1 in 1 CARTON	TABLET, FILM COATED	1	16
65757-653-41	LYBALVI	7 in 1 BOTTLE	TABLET, FILM COATED	7	16
65757-653-42	LYBALVI	1 in 1 CARTON	TABLET, FILM COATED	1	16
65757-653-42	LYBALVI	30 in 1 BOTTLE	TABLET, FILM COATED	30	16
65757-653-44	LYBALVI	90 in 1 BOTTLE	TABLET, FILM COATED	90	16
65757-653-44	LYBALVI	1 in 1 CARTON	TABLET, FILM COATED	1	16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65757-653-40	EA - Each	65757-653	f12fc283-ae31-4871-8fa7-327b9587bcca	1	2023-12-05
65757-653-42	EA - Each	65757-653	4ededc22-adbd-4b20-ac4b-c025a4e77a29	1	2021-10-08
65757-653-44	EA - Each	65757-653	4a031168-9ab1-44cf-9571-362eccbac074	1	2021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65757-653	LYBALVI (OLANZAPINE AND SAMIDORPHAN L-MALATE) TABLET, FILM COATED [ALKERMES, INC.]	13	Current NDC, Legacy NDC, 8 package rows	20250316_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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LYBALVI	OLANZAPINE AND SAMIDORPHAN L-MALATE	Alkermes, Inc.	32ffddd1-4e2b-45d9-9b36-bb730167ec80	2026-01-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 213378 application number: NDA213378 ndc (product): 65757-653

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
N7U69T4SZR	OLANZAPINE	132539-06-1	OLANZAPINE
0AJQ5N56E0	SAMIDORPHAN L-MALATE	1204592-75-5	SAMIDORPHAN L-MALATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2570401	LYBALVI 10 MG / 10 MG Oral Tablet	PSN	32ffddd1-4e2b-45d9-9b36-bb730167ec80	16
2570404	LYBALVI 15 MG / 10 MG Oral Tablet	PSN	32ffddd1-4e2b-45d9-9b36-bb730167ec80	16
2570407	LYBALVI 20 MG / 10 MG Oral Tablet	PSN	32ffddd1-4e2b-45d9-9b36-bb730167ec80	16
2570398	LYBALVI 5 MG / 10 MG Oral Tablet	PSN	32ffddd1-4e2b-45d9-9b36-bb730167ec80	16
2570399	OLANZapine 10 MG / samidorphan 10 MG Oral Tablet	PSN	32ffddd1-4e2b-45d9-9b36-bb730167ec80	16
2570402	OLANZapine 15 MG / samidorphan 10 MG Oral Tablet	PSN	32ffddd1-4e2b-45d9-9b36-bb730167ec80	16
2570405	OLANZapine 20 MG / samidorphan 10 MG Oral Tablet	PSN	32ffddd1-4e2b-45d9-9b36-bb730167ec80	16
2570392	OLANZapine 5 MG / samidorphan 10 MG Oral Tablet	PSN	32ffddd1-4e2b-45d9-9b36-bb730167ec80	16
2570401	olanzapine 10 MG / samidorphan 10 MG Oral Tablet [Lybalvi]	SBD	32ffddd1-4e2b-45d9-9b36-bb730167ec80	16
2570404	olanzapine 15 MG / samidorphan 10 MG Oral Tablet [Lybalvi]	SBD	32ffddd1-4e2b-45d9-9b36-bb730167ec80	16
2570407	olanzapine 20 MG / samidorphan 10 MG Oral Tablet [Lybalvi]	SBD	32ffddd1-4e2b-45d9-9b36-bb730167ec80	16
2570398	olanzapine 5 MG / samidorphan 10 MG Oral Tablet [Lybalvi]	SBD	32ffddd1-4e2b-45d9-9b36-bb730167ec80	16
2570399	olanzapine 10 MG / samidorphan 10 MG Oral Tablet	SCD	32ffddd1-4e2b-45d9-9b36-bb730167ec80	16
2570402	olanzapine 15 MG / samidorphan 10 MG Oral Tablet	SCD	32ffddd1-4e2b-45d9-9b36-bb730167ec80	16
2570405	olanzapine 20 MG / samidorphan 10 MG Oral Tablet	SCD	32ffddd1-4e2b-45d9-9b36-bb730167ec80	16
2570392	olanzapine 5 MG / samidorphan 10 MG Oral Tablet	SCD	32ffddd1-4e2b-45d9-9b36-bb730167ec80	16
2570401	Lybalvi (olanzapine 10 MG / samidorphan 10 MG (as samidorphan L-malate 13.6 MG)) Oral Tablet	SY	32ffddd1-4e2b-45d9-9b36-bb730167ec80	16
2570401	Lybalvi (olanzapine 10 MG / samidorphan 10 MG) Oral Tablet	SY	32ffddd1-4e2b-45d9-9b36-bb730167ec80	16
2570404	Lybalvi (olanzapine 15 MG / samidorphan 10 MG (as samidorphan L-malate 13.6 MG)) Oral Tablet	SY	32ffddd1-4e2b-45d9-9b36-bb730167ec80	16
2570404	Lybalvi (olanzapine 15 MG / samidorphan 10 MG) Oral Tablet	SY	32ffddd1-4e2b-45d9-9b36-bb730167ec80	16
2570407	Lybalvi (olanzapine 20 MG / samidorphan 10 MG (as samidorphan L-malate 13.6 MG)) Oral Tablet	SY	32ffddd1-4e2b-45d9-9b36-bb730167ec80	16
2570407	Lybalvi (olanzapine 20 MG / samidorphan 10 MG) Oral Tablet	SY	32ffddd1-4e2b-45d9-9b36-bb730167ec80	16
2570398	Lybalvi (olanzapine 5 MG / samidorphan 10 MG (as samidorphan L-malate 13.6 MG)) Oral Tablet	SY	32ffddd1-4e2b-45d9-9b36-bb730167ec80	16
2570398	Lybalvi (olanzapine 5 MG / samidorphan 10 MG) Oral Tablet	SY	32ffddd1-4e2b-45d9-9b36-bb730167ec80	16
2570399	olanzapine 10 MG / samidorphan 10 MG (as samidorphan L-malate 13.6 MG) Oral Tablet	SY	32ffddd1-4e2b-45d9-9b36-bb730167ec80	16
2570402	olanzapine 15 MG / samidorphan 10 MG (as samidorphan L-malate 13.6 MG) Oral Tablet	SY	32ffddd1-4e2b-45d9-9b36-bb730167ec80	16
2570405	olanzapine 20 MG / samidorphan 10 MG (as samidorphan L-malate 13.6 MG) Oral Tablet	SY	32ffddd1-4e2b-45d9-9b36-bb730167ec80	16
2570392	olanzapine 5 MG / samidorphan 10 MG (as samidorphan L-malate 13.6 MG) Oral Tablet	SY	32ffddd1-4e2b-45d9-9b36-bb730167ec80	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65757-653-03	65757065303	153846 TABLET, FILM COATED in 1 CONTAINER (65757-653-03)		28-MAY-21				Current
65757-653-40	65757065340	1 BOTTLE in 1 CARTON (65757-653-40) > 7 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2021-09-20	0000-00-00	No	No	Current
65757-653-41	65757065341	1 BOTTLE in 1 CARTON (65757-653-41) / 7 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2021-09-20	0000-00-00	Yes	No	Current
65757-653-42	65757065342	1 BOTTLE in 1 CARTON (65757-653-42) / 30 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2021-09-20	0000-00-00	No	No	Current
65757-653-44	65757065344	1 BOTTLE in 1 CARTON (65757-653-44) > 90 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2021-09-20	0000-00-00	No	No	Current