Home NDC 87519-003 LYVISPAH
Product NDC 87519-003
11-digit product format 875190003
Labeler code 87519
Product ID 87519-003_5c18f6d4-5f52-0cb7-e063-6294a90a835e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name baclofen
Dosage form GRANULE
Route ORAL
Labeler Anvi Pharmaceuticals Inc
Application NDA215422
Marketing category NDA
Marketing start 2026-09-01
Substance BACLOFEN
Active strength 10 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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 TE codes 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 · 105 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N215422-001 LYVISPAH 5MG/PACKET GRANULE / ORAL RLD 2021-11-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215422-002 LYVISPAH 10MG/PACKET GRANULE / ORAL RLD 2021-11-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215422-003 LYVISPAH 20MG/PACKET GRANULE / ORAL RLD 2021-11-22 84e616aacf4f…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…
Observed Orange Book patent history# Patent history page 1 of 13 · 492 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N215422-001 10792262 2039-07-29 U-3263 Drug product 2021-12-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215422-001 11654124 2039-07-29 Drug product 2023-06-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215422-001 11931328 2039-07-29 Drug product 2024-04-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215422-001 11491125 2041-09-29 U-3488 Drug product 2022-12-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215422-001 11491125 2041-09-29 U-3489 Drug product 2022-12-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215422-001 11850225 2041-09-29 U-3488 Drug product 2024-01-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215422-001 11850225 2041-09-29 U-3489 Drug product 2024-01-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215422-002 10792262 2039-07-29 U-3263 Drug product 2021-12-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215422-002 11654124 2039-07-29 Drug product 2023-06-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215422-002 11931328 2039-07-29 Drug product 2024-04-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215422-002 11491125 2041-09-29 U-3489 Drug product 2022-12-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215422-002 11491125 2041-09-29 U-3488 Drug product 2022-12-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215422-002 11850225 2041-09-29 U-3489 Drug product 2024-01-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215422-002 11850225 2041-09-29 U-3488 Drug product 2024-01-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215422-003 10792262 2039-07-29 U-3263 Drug product 2021-12-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215422-003 11654124 2039-07-29 Drug product 2023-06-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215422-003 11931328 2039-07-29 Drug product 2024-04-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215422-003 11491125 2041-09-29 U-3489 Drug product 2022-12-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215422-003 11491125 2041-09-29 U-3488 Drug product 2022-12-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215422-003 11850225 2041-09-29 U-3489 Drug product 2024-01-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215422-003 11850225 2041-09-29 U-3488 Drug product 2024-01-22 84e616aacf4f…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…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base LYVISPAH
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BACLOFEN 10 mg/1
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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 87519-003-90 87519000390 90 PACKET in 1 CARTON (87519-003-90) / 1 GRANULE in 1 PACKET 90 packet 2026-09-01 No No Current