Lyvispah

Product NDC: 70257-412
11-digit product format: 702570412
Labeler code: 70257
Product ID: 70257-412_c2cbebf8-e2d6-4515-adbe-c3f7e5091a1b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: baclofen
Dosage form: GRANULE
Route: ORAL
Labeler: Saol Therapeutics Inc
Application: NDA215422
Marketing category: NDA
Marketing start: 2021-11-22
Marketing end: 0000-00-00
Substance: BACLOFEN
Active strength: 5 mg/1
Pharmacologic classes: GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	70257-412		I	Inactivated by FDA		2026-09-09
excluded package	package	70257-412	70257-412-87	I	Inactivated by FDA		2026-09-09

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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70257-412-87	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70257-412-87	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70257-412-87	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70257-412-87	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70257-412-87	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70257-412-87	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70257-412-87	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70257-412-87	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70257-412-87	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N215422-001	LYVISPAH	BACLOFEN	5MG/PACKET	GRANULE / ORAL	RLD	2021-11-22
N215422-002	LYVISPAH	BACLOFEN	10MG/PACKET	GRANULE / ORAL	RLD	2021-11-22
N215422-003	LYVISPAH	BACLOFEN	20MG/PACKET	GRANULE / ORAL	RLD	2021-11-22

Orange Book patents#

Current patent rows page 1 of 1 · 21 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N215422-001	10792262	2039-07-29	U-3263	Drug product	2021-12-21
N215422-001	11654124	2039-07-29		Drug product	2023-06-14
N215422-001	11931328	2039-07-29		Drug product	2024-04-02
N215422-001	11491125	2041-09-29	U-3488	Drug product	2022-12-05
N215422-001	11491125	2041-09-29	U-3489	Drug product	2022-12-05
N215422-001	11850225	2041-09-29	U-3488	Drug product	2024-01-22
N215422-001	11850225	2041-09-29	U-3489	Drug product	2024-01-22
N215422-002	10792262	2039-07-29	U-3263	Drug product	2021-12-21
N215422-002	11654124	2039-07-29		Drug product	2023-06-14
N215422-002	11931328	2039-07-29		Drug product	2024-04-02
N215422-002	11491125	2041-09-29	U-3488	Drug product	2022-12-05
N215422-002	11491125	2041-09-29	U-3489	Drug product	2022-12-05
N215422-002	11850225	2041-09-29	U-3488	Drug product	2024-01-22
N215422-002	11850225	2041-09-29	U-3489	Drug product	2024-01-22
N215422-003	10792262	2039-07-29	U-3263	Drug product	2021-12-21
N215422-003	11654124	2039-07-29		Drug product	2023-06-14
N215422-003	11931328	2039-07-29		Drug product	2024-04-02
N215422-003	11491125	2041-09-29	U-3488	Drug product	2022-12-05
N215422-003	11491125	2041-09-29	U-3489	Drug product	2022-12-05
N215422-003	11850225	2041-09-29	U-3488	Drug product	2024-01-22
N215422-003	11850225	2041-09-29	U-3489	Drug product	2024-01-22

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 3 · 102 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	N215422-001	LYVISPAH	5MG/PACKET	GRANULE / ORAL	RLD	2021-11-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215422-002	LYVISPAH	10MG/PACKET	GRANULE / ORAL	RLD	2021-11-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215422-003	LYVISPAH	20MG/PACKET	GRANULE / ORAL	RLD	2021-11-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215422-001	LYVISPAH	5MG/PACKET	GRANULES / ORAL	RLD	2021-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215422-002	LYVISPAH	10MG/PACKET	GRANULES / ORAL	RLD	2021-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215422-003	LYVISPAH	20MG/PACKET	GRANULES / ORAL	RLD	2021-11-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215422-001	LYVISPAH	5MG/PACKET	GRANULES / ORAL	RLD	2021-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215422-002	LYVISPAH	10MG/PACKET	GRANULES / ORAL	RLD	2021-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215422-003	LYVISPAH	20MG/PACKET	GRANULES / ORAL	RLD	2021-11-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215422-001	LYVISPAH	5MG/PACKET	GRANULES / ORAL	RLD	2021-11-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215422-002	LYVISPAH	10MG/PACKET	GRANULES / ORAL	RLD	2021-11-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215422-003	LYVISPAH	20MG/PACKET	GRANULES / ORAL	RLD	2021-11-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215422-001	LYVISPAH	5MG/PACKET	GRANULES / ORAL	RLD	2021-11-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215422-002	LYVISPAH	10MG/PACKET	GRANULES / ORAL	RLD	2021-11-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215422-003	LYVISPAH	20MG/PACKET	GRANULES / ORAL	RLD, RS	2021-11-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215422-001	LYVISPAH	5MG/PACKET	GRANULES / ORAL	RLD	2021-11-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215422-002	LYVISPAH	10MG/PACKET	GRANULES / ORAL	RLD	2021-11-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215422-003	LYVISPAH	20MG/PACKET	GRANULES / ORAL	RLD, RS	2021-11-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215422-001	LYVISPAH	5MG/PACKET	GRANULES / ORAL	RLD	2021-11-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215422-002	LYVISPAH	10MG/PACKET	GRANULES / ORAL	RLD	2021-11-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215422-003	LYVISPAH	20MG/PACKET	GRANULES / ORAL	RLD, RS	2021-11-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215422-001	LYVISPAH	5MG/PACKET	GRANULES / ORAL	RLD	2021-11-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215422-002	LYVISPAH	10MG/PACKET	GRANULES / ORAL	RLD	2021-11-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215422-003	LYVISPAH	20MG/PACKET	GRANULES / ORAL	RLD, RS	2021-11-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215422-001	LYVISPAH	5MG/PACKET	GRANULES / ORAL	RLD	2021-11-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215422-002	LYVISPAH	10MG/PACKET	GRANULES / ORAL	RLD	2021-11-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215422-003	LYVISPAH	20MG/PACKET	GRANULES / ORAL	RLD, RS	2021-11-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215422-001	LYVISPAH	5MG/PACKET	GRANULES / ORAL	RLD	2021-11-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215422-002	LYVISPAH	10MG/PACKET	GRANULES / ORAL	RLD	2021-11-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215422-003	LYVISPAH	20MG/PACKET	GRANULES / ORAL	RLD, RS	2021-11-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215422-001	LYVISPAH	5MG/PACKET	GRANULES / ORAL	RLD	2021-11-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215422-002	LYVISPAH	10MG/PACKET	GRANULES / ORAL	RLD	2021-11-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215422-003	LYVISPAH	20MG/PACKET	GRANULES / ORAL	RLD, RS	2021-11-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215422-001	LYVISPAH	5MG/PACKET	GRANULES / ORAL	RLD	2021-11-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215422-002	LYVISPAH	10MG/PACKET	GRANULES / ORAL	RLD	2021-11-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215422-003	LYVISPAH	20MG/PACKET	GRANULES / ORAL	RLD, RS	2021-11-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215422-001	LYVISPAH	5MG/PACKET	GRANULES / ORAL	RLD	2021-11-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215422-002	LYVISPAH	10MG/PACKET	GRANULES / ORAL	RLD	2021-11-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215422-003	LYVISPAH	20MG/PACKET	GRANULES / ORAL	RLD, RS	2021-11-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215422-001	LYVISPAH	5MG/PACKET	GRANULES / ORAL	RLD	2021-11-22	`1e350fbaab3a…`

Observed Orange Book patent history#

Patent history page 1 of 12 · 471 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	N215422-001	10792262	2039-07-29	U-3263	Drug product	2021-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215422-001	11654124	2039-07-29		Drug product	2023-06-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215422-001	11931328	2039-07-29		Drug product	2024-04-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215422-001	11491125	2041-09-29	U-3488	Drug product	2022-12-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215422-001	11491125	2041-09-29	U-3489	Drug product	2022-12-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215422-001	11850225	2041-09-29	U-3488	Drug product	2024-01-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215422-001	11850225	2041-09-29	U-3489	Drug product	2024-01-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215422-002	10792262	2039-07-29	U-3263	Drug product	2021-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215422-002	11654124	2039-07-29		Drug product	2023-06-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215422-002	11931328	2039-07-29		Drug product	2024-04-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215422-002	11491125	2041-09-29	U-3489	Drug product	2022-12-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215422-002	11491125	2041-09-29	U-3488	Drug product	2022-12-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215422-002	11850225	2041-09-29	U-3489	Drug product	2024-01-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215422-002	11850225	2041-09-29	U-3488	Drug product	2024-01-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215422-003	10792262	2039-07-29	U-3263	Drug product	2021-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215422-003	11654124	2039-07-29		Drug product	2023-06-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215422-003	11931328	2039-07-29		Drug product	2024-04-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215422-003	11491125	2041-09-29	U-3489	Drug product	2022-12-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215422-003	11491125	2041-09-29	U-3488	Drug product	2022-12-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215422-003	11850225	2041-09-29	U-3489	Drug product	2024-01-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215422-003	11850225	2041-09-29	U-3488	Drug product	2024-01-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215422-001	10792262	2039-07-29	U-3263	Drug product	2021-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215422-001	11654124	2039-07-29		Drug product	2023-06-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215422-001	11931328	2039-07-29		Drug product	2024-04-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215422-001	11491125	2041-09-29	U-3488	Drug product	2022-12-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215422-001	11491125	2041-09-29	U-3489	Drug product	2022-12-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215422-001	11850225	2041-09-29	U-3488	Drug product	2024-01-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215422-001	11850225	2041-09-29	U-3489	Drug product	2024-01-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215422-002	10792262	2039-07-29	U-3263	Drug product	2021-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215422-002	11654124	2039-07-29		Drug product	2023-06-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215422-002	11931328	2039-07-29		Drug product	2024-04-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215422-002	11491125	2041-09-29	U-3489	Drug product	2022-12-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215422-002	11491125	2041-09-29	U-3488	Drug product	2022-12-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215422-002	11850225	2041-09-29	U-3489	Drug product	2024-01-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215422-002	11850225	2041-09-29	U-3488	Drug product	2024-01-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215422-003	10792262	2039-07-29	U-3263	Drug product	2021-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215422-003	11654124	2039-07-29		Drug product	2023-06-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215422-003	11931328	2039-07-29		Drug product	2024-04-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215422-003	11491125	2041-09-29	U-3489	Drug product	2022-12-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215422-003	11491125	2041-09-29	U-3488	Drug product	2022-12-05	`011fe1cb6892…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1e25d01b-2e92-4765-bec7-8a0fd7bdc346	Product name	2	20251208
1b1393e5-f2d8-42f5-a070-e3416d619667	Product name	1	20250804
88583480-702d-4dfe-a31c-9c00abd818f8	Product name	7	20250729
1cf3c538-592e-4b4b-869e-51d4bf3ca83d	Product name	2	20240703
6e532d1f-e0b5-46eb-a2be-d70bd338df9d	Product name	1	20220613
ef6bc0bf-8134-f06b-70d9-4980df6f808e	Product name	5	20210615
eeec0918-7a2f-44bf-83d6-1216e507adbf	Product name	3	20191217
a5300adb-f538-4abb-a49e-f8f0b8d9ac75	Product name	1	20190611

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70257-412-87	2025-01-30	C162847	48780-1	2cef2736-89eb-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use LYVISPAH safely and effectively. See full prescribing information for LYVISPAH. LYVISPAH (baclofen) oral granules Initial U.S. Approval: 1977

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70257-412-87	Lyvispah	1 in 1 PACKET	GRANULE	1		2
70257-412-87	Lyvispah	90 in 1 BOTTLE, UNIT-DOSE	GRANULE	90		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70257-412-87	EA - Each	70257-412	23af3ca1-144c-436e-bdde-3b298b5b556a	1	2022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70257-412	LYVISPAH (BACLOFEN) GRANULE [SAOL THERAPEUTICS INC]	2	Legacy NDC, 2 package rows	20230115_a7d2dc58-e167-4ebc-ac1d-932f000fb412.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
LYVISPAH	BACLOFEN	Amneal Pharmaceuticals LLC	f8992a56-9010-4c4b-84d5-ddcc3e2c3317	2023-04-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 215422 application number: NDA215422

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
H789N3FKE8	BACLOFEN	1134-47-0	BACLOFEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2586589	baclofen 10 MG Oral Granules	PSN	a7d2dc58-e167-4ebc-ac1d-932f000fb412	2
2586596	baclofen 20 MG Oral Granules	PSN	a7d2dc58-e167-4ebc-ac1d-932f000fb412	2
2586599	baclofen 5 MG Oral Granules	PSN	a7d2dc58-e167-4ebc-ac1d-932f000fb412	2
2586595	LYVISPAH 10 MG Oral Granules	PSN	a7d2dc58-e167-4ebc-ac1d-932f000fb412	2
2586598	LYVISPAH 20 MG Oral Granules	PSN	a7d2dc58-e167-4ebc-ac1d-932f000fb412	2
2586601	LYVISPAH 5 MG Oral Granules	PSN	a7d2dc58-e167-4ebc-ac1d-932f000fb412	2
2586595	baclofen 10 MG Oral Granules [Lyvispah]	SBD	a7d2dc58-e167-4ebc-ac1d-932f000fb412	2
2586598	baclofen 20 MG Oral Granules [Lyvispah]	SBD	a7d2dc58-e167-4ebc-ac1d-932f000fb412	2
2586601	baclofen 5 MG Oral Granules [Lyvispah]	SBD	a7d2dc58-e167-4ebc-ac1d-932f000fb412	2
2586589	baclofen 10 MG Oral Granules	SCD	a7d2dc58-e167-4ebc-ac1d-932f000fb412	2
2586596	baclofen 20 MG Oral Granules	SCD	a7d2dc58-e167-4ebc-ac1d-932f000fb412	2
2586599	baclofen 5 MG Oral Granules	SCD	a7d2dc58-e167-4ebc-ac1d-932f000fb412	2
2586595	Lyvispah 10 MG Oral Granules	SY	a7d2dc58-e167-4ebc-ac1d-932f000fb412	2
2586598	Lyvispah 20 MG Oral Granules	SY	a7d2dc58-e167-4ebc-ac1d-932f000fb412	2
2586601	Lyvispah 5 MG Oral Granules	SY	a7d2dc58-e167-4ebc-ac1d-932f000fb412	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70257-412-87	70257041287	90 PACKET in 1 BOTTLE, UNIT-DOSE (70257-412-87) > 1 GRANULE in 1 PACKET	90 packet	2021-11-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lyvispah - Saol Therapeutics Inc	Saol Therapeutics Inc	2021-11-26	HUMAN PRESCRIPTION DRUG LABEL	2