Lyvispah

Product NDC
70257-414
11-digit product format
702570414
Labeler code
70257
Product ID
70257-414_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
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
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e25d01b-2e92-4765-bec7-8a0fd7bdc346Product name220251208
1b1393e5-f2d8-42f5-a070-e3416d619667Product name120250804
88583480-702d-4dfe-a31c-9c00abd818f8Product name720250729
1cf3c538-592e-4b4b-869e-51d4bf3ca83dProduct name220240703
6e532d1f-e0b5-46eb-a2be-d70bd338df9dProduct name120220613
ef6bc0bf-8134-f06b-70d9-4980df6f808eProduct name520210615
eeec0918-7a2f-44bf-83d6-1216e507adbfProduct name320191217
a5300adb-f538-4abb-a49e-f8f0b8d9ac75Product name120190611

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70257-414-87Lyvispah90 in 1 BOTTLE, UNIT-DOSEGRANULE902
70257-414-87Lyvispah1 in 1 PACKETGRANULE12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70257-414-87EA - Each70257-414bda26527-8d5c-4b06-8e47-412e99c7b35312022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70257-414LYVISPAH (BACLOFEN) GRANULE [SAOL THERAPEUTICS INC]2Legacy NDC, 2 package rows20230115_a7d2dc58-e167-4ebc-ac1d-932f000fb412.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2586589baclofen 10 MG Oral GranulesPSNa7d2dc58-e167-4ebc-ac1d-932f000fb4122
2586596baclofen 20 MG Oral GranulesPSNa7d2dc58-e167-4ebc-ac1d-932f000fb4122
2586599baclofen 5 MG Oral GranulesPSNa7d2dc58-e167-4ebc-ac1d-932f000fb4122
2586595LYVISPAH 10 MG Oral GranulesPSNa7d2dc58-e167-4ebc-ac1d-932f000fb4122
2586598LYVISPAH 20 MG Oral GranulesPSNa7d2dc58-e167-4ebc-ac1d-932f000fb4122
2586601LYVISPAH 5 MG Oral GranulesPSNa7d2dc58-e167-4ebc-ac1d-932f000fb4122
2586595baclofen 10 MG Oral Granules [Lyvispah]SBDa7d2dc58-e167-4ebc-ac1d-932f000fb4122
2586598baclofen 20 MG Oral Granules [Lyvispah]SBDa7d2dc58-e167-4ebc-ac1d-932f000fb4122
2586601baclofen 5 MG Oral Granules [Lyvispah]SBDa7d2dc58-e167-4ebc-ac1d-932f000fb4122
2586589baclofen 10 MG Oral GranulesSCDa7d2dc58-e167-4ebc-ac1d-932f000fb4122
2586596baclofen 20 MG Oral GranulesSCDa7d2dc58-e167-4ebc-ac1d-932f000fb4122
2586599baclofen 5 MG Oral GranulesSCDa7d2dc58-e167-4ebc-ac1d-932f000fb4122
2586595Lyvispah 10 MG Oral GranulesSYa7d2dc58-e167-4ebc-ac1d-932f000fb4122
2586598Lyvispah 20 MG Oral GranulesSYa7d2dc58-e167-4ebc-ac1d-932f000fb4122
2586601Lyvispah 5 MG Oral GranulesSYa7d2dc58-e167-4ebc-ac1d-932f000fb4122

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70257-414-877025704148790 PACKET in 1 BOTTLE, UNIT-DOSE (70257-414-87) > 1 GRANULE in 1 PACKET90 packet2021-11-220000-00-00NoNoCurrent