Home NDC 64896-078-09 LYVISPAH
Product NDC 64896-078
Requested package NDC 64896-078-09
11-digit product format 648960078
Labeler code 64896
Product ID 64896-078_d042d45f-7097-47e0-921f-0442e00d47e0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name baclofen
Dosage form GRANULE
Route ORAL
Labeler Amneal Pharmaceuticals LLC
Application NDA215422
Marketing category NDA
Marketing start 2023-06-01
Substance BACLOFEN
Active strength 20 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 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BACLOFEN 20 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination H789N3FKE8 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2586589 Internal RxNorm lookup 2586595 Internal RxNorm lookup 2586596 Internal RxNorm lookup 2586598 Internal RxNorm lookup 2586599 Internal RxNorm lookup 2586601 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 64896-078-09 LYVISPAH 1 in 1 PACKET GRANULE 1 5 64896-078-09 LYVISPAH 90 in 1 CARTON GRANULE 90 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64896-078 LYVISPAH (BACLOFEN) GRANULE [AMNEAL PHARMACEUTICALS LLC] 5 Current NDC, 2 package rows 20241025_f8992a56-9010-4c4b-84d5-ddcc3e2c3317.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 64896-078-09 64896007809 90 PACKET in 1 CARTON (64896-078-09) / 1 GRANULE in 1 PACKET 90 packet 2023-06-01 No No Current