FDA.reportPublic FDA data

Lioresal

Product NDC
58281-563
11-digit product format
582810563
Labeler code
58281
Product ID
58281-563_824b1807-be48-4239-bfdc-2d1d15b42c71
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
baclofen
Dosage form
INJECTION
Route
INTRATHECAL
Labeler
Medtronic Neuromodulation
Application
NDA020075
Marketing category
NDA
Marketing start
2003-05-08
Marketing end
0000-00-00
Substance
BACLOFEN
Active strength
2 mg/mL
Pharmacologic classes
GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58281-563-012020-01-31C16284748780-19d75b9d0-618a-f424-e053-dadaa90a57ce351cde63-00fa-404a-92df-cb055e991840
58281-563-022020-01-31C16284748780-19d75b9d0-618a-f424-e053-dadaa90a57ce351cde63-00fa-404a-92df-cb055e991840

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58281-563-01Lioresal1 in 1 PACKAGE, COMBINATIONINJECTION112
58281-563-01Lioresal20 mL in 1 AMPULEINJECTION2012
58281-563-02Lioresal20 mL in 1 AMPULEINJECTION2012
58281-563-02Lioresal2 in 1 PACKAGE, COMBINATIONINJECTION212

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58281-563-01ML - Milliliter58281-563ce9618a6-0da0-414f-894c-170e9fda699d12012-07-24
58281-563-02ML - Milliliter58281-563e5e0f190-671a-4cb9-8cc2-d18fbfbbd90b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
baclofenACTIVE INGREDIENTH789N3FKE8LIORESAL (BACLOFEN) INJECTION [MEDTRONIC NEUROMODULATION]10
baclofenACTIVE MOIETYH789N3FKE8LIORESAL (BACLOFEN) INJECTION [MEDTRONIC NEUROMODULATION]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58281-563LIORESAL (BACLOFEN) INJECTION [MEDTRONIC NEUROMODULATION]12Legacy NDC, 4 package rows20161013_351cde63-00fa-404a-92df-cb055e991840.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308516baclofen 0.05 MG in 1 ML (50 MCG/ML) InjectionPSN351cde63-00fa-404a-92df-cb055e99184012
308517baclofen 10 MG in 20 ML (500 MCG/ML) InjectionPSN351cde63-00fa-404a-92df-cb055e99184012
1666622baclofen 10 MG in 5 ML (2,000 MCG/ML) InjectionPSN351cde63-00fa-404a-92df-cb055e99184012
1666613baclofen 40 MG in 20 ML (2,000 MCG/ML) InjectionPSN351cde63-00fa-404a-92df-cb055e99184012
805679LIORESAL INTRATHECAL 0.05 MG in 1 ML (50 MCG/ML) InjectionPSN351cde63-00fa-404a-92df-cb055e99184012
805678LIORESAL INTRATHECAL 10 MG in 20 ML (500 MCG/ML) InjectionPSN351cde63-00fa-404a-92df-cb055e99184012
1666623LIORESAL INTRATHECAL 10 MG in 5 ML (2,000 MCG/ML) InjectionPSN351cde63-00fa-404a-92df-cb055e99184012
1666620LIORESAL INTRATHECAL 40 MG in 20 ML (2,000 MCG/ML) InjectionPSN351cde63-00fa-404a-92df-cb055e99184012
8056791 ML baclofen 0.05 MG/ML Injection [Lioresal]SBD351cde63-00fa-404a-92df-cb055e99184012
80567820 ML baclofen 0.5 MG/ML Injection [Lioresal]SBD351cde63-00fa-404a-92df-cb055e99184012
166662020 ML baclofen 2 MG/ML Injection [Lioresal]SBD351cde63-00fa-404a-92df-cb055e99184012
16666235 ML baclofen 2 MG/ML Injection [Lioresal]SBD351cde63-00fa-404a-92df-cb055e99184012
3085161 ML baclofen 0.05 MG/ML InjectionSCD351cde63-00fa-404a-92df-cb055e99184012
30851720 ML baclofen 0.5 MG/ML InjectionSCD351cde63-00fa-404a-92df-cb055e99184012
166661320 ML baclofen 2 MG/ML InjectionSCD351cde63-00fa-404a-92df-cb055e99184012
16666225 ML baclofen 2 MG/ML InjectionSCD351cde63-00fa-404a-92df-cb055e99184012
8056791 ML Lioresal 0.05 MG/ML InjectionSY351cde63-00fa-404a-92df-cb055e99184012
80567820 ML Lioresal 0.5 MG/ML InjectionSY351cde63-00fa-404a-92df-cb055e99184012
166662020 ML Lioresal 2 MG/ML InjectionSY351cde63-00fa-404a-92df-cb055e99184012
16666235 ML Lioresal 2 MG/ML InjectionSY351cde63-00fa-404a-92df-cb055e99184012
308516baclofen 0.05 MG per 1 ML InjectionSY351cde63-00fa-404a-92df-cb055e99184012
1666622baclofen 10 MG per 5 ML (2,000 MCG/ML) InjectionSY351cde63-00fa-404a-92df-cb055e99184012
308517baclofen 10,000 MCG per 20 ML InjectionSY351cde63-00fa-404a-92df-cb055e99184012
1666613baclofen 40,000 MCG per 20 ML InjectionSY351cde63-00fa-404a-92df-cb055e99184012
308516baclofen 50 MCG per 1 ML InjectionSY351cde63-00fa-404a-92df-cb055e99184012
805679Lioresal 0.05 MG per 1 ML InjectionSY351cde63-00fa-404a-92df-cb055e99184012
805678Lioresal 10 MG per 20 ML (500 MCG/ML) InjectionSY351cde63-00fa-404a-92df-cb055e99184012
1666623Lioresal 10 MG per 5 ML (2,000 MCG/ML) InjectionSY351cde63-00fa-404a-92df-cb055e99184012
1666620Lioresal 40 MG per 20 ML (2,000 MCG/ML) InjectionSY351cde63-00fa-404a-92df-cb055e99184012
805679Lioresal 50 MCG per 1 ML InjectionSY351cde63-00fa-404a-92df-cb055e99184012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
58281-563-01582810563011 in 1 PACKAGE, COMBINATIONHistorical
58281-563-025828105630220 mL in 1 AMPULE20 mlHistorical