FDA.reportPublic FDA data

Lioresal (baclofen)

Product NDC
70121-2496
11-digit product format
701212496
Labeler code
70121
Product ID
70121-2496_d68a08e0-d0d9-4144-be01-47b636dfa7e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
baclofen
Dosage form
INJECTION
Route
INTRATHECAL
Labeler
Amneal Pharmaceuticals LLC
Application
NDA020075
Marketing category
NDA
Marketing start
2022-06-12
Substance
BACLOFEN
Active strength
.05 mg/mL
Pharmacologic classes
GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lioresal (baclofen)
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACLOFEN.05 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiH789N3FKE8
Rxcui308516, 308517, 805678, 805679, 1666613, 1666620, 1666622, 1666623

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70121-2496-5Lioresal (baclofen)1 mL in 1 AMPULEINJECTION129
70121-2496-5Lioresal (baclofen)5 in 1 BOXINJECTION529

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70121-2496-5ML - Milliliter70121-24964d6a46c2-81df-4933-a266-3f754395ffe012023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70121-2496LIORESAL (BACLOFEN) (BACLOFEN) KIT LIORESAL (BACLOFEN) (BACLOFEN) INJECTION [AMNEAL PHARMACEUTICALS LLC]26Current NDC, 2 package rows20241211_6f3bdcc0-ffc8-4911-8c35-958c8103a2c5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308516baclofen 0.05 MG in 1 ML (50 MCG/ML) InjectionPSN6f3bdcc0-ffc8-4911-8c35-958c8103a2c529
308517baclofen 10 MG in 20 ML (500 MCG/ML) InjectionPSN6f3bdcc0-ffc8-4911-8c35-958c8103a2c529
1666622baclofen 10 MG in 5 ML (2,000 MCG/ML) InjectionPSN6f3bdcc0-ffc8-4911-8c35-958c8103a2c529
1666613baclofen 40 MG in 20 ML (2,000 MCG/ML) InjectionPSN6f3bdcc0-ffc8-4911-8c35-958c8103a2c529
805679LIORESAL INTRATHECAL 0.05 MG in 1 ML (50 MCG/ML) InjectionPSN6f3bdcc0-ffc8-4911-8c35-958c8103a2c529
805678LIORESAL INTRATHECAL 10 MG in 20 ML (500 MCG/ML) InjectionPSN6f3bdcc0-ffc8-4911-8c35-958c8103a2c529
1666623LIORESAL INTRATHECAL 10 MG in 5 ML (2,000 MCG/ML) InjectionPSN6f3bdcc0-ffc8-4911-8c35-958c8103a2c529
1666620LIORESAL INTRATHECAL 40 MG in 20 ML (2,000 MCG/ML) InjectionPSN6f3bdcc0-ffc8-4911-8c35-958c8103a2c529
8056791 ML baclofen 0.05 MG/ML Injection [Lioresal]SBD6f3bdcc0-ffc8-4911-8c35-958c8103a2c529
80567820 ML baclofen 0.5 MG/ML Injection [Lioresal]SBD6f3bdcc0-ffc8-4911-8c35-958c8103a2c529
166662020 ML baclofen 2 MG/ML Injection [Lioresal]SBD6f3bdcc0-ffc8-4911-8c35-958c8103a2c529
16666235 ML baclofen 2 MG/ML Injection [Lioresal]SBD6f3bdcc0-ffc8-4911-8c35-958c8103a2c529
3085161 ML baclofen 0.05 MG/ML InjectionSCD6f3bdcc0-ffc8-4911-8c35-958c8103a2c529
30851720 ML baclofen 0.5 MG/ML InjectionSCD6f3bdcc0-ffc8-4911-8c35-958c8103a2c529
166661320 ML baclofen 2 MG/ML InjectionSCD6f3bdcc0-ffc8-4911-8c35-958c8103a2c529
16666225 ML baclofen 2 MG/ML InjectionSCD6f3bdcc0-ffc8-4911-8c35-958c8103a2c529
8056791 ML Lioresal 0.05 MG/ML InjectionSY6f3bdcc0-ffc8-4911-8c35-958c8103a2c529
80567820 ML Lioresal 0.5 MG/ML InjectionSY6f3bdcc0-ffc8-4911-8c35-958c8103a2c529
166662020 ML Lioresal 2 MG/ML InjectionSY6f3bdcc0-ffc8-4911-8c35-958c8103a2c529
16666235 ML Lioresal 2 MG/ML InjectionSY6f3bdcc0-ffc8-4911-8c35-958c8103a2c529
308516baclofen 0.05 MG per 1 ML InjectionSY6f3bdcc0-ffc8-4911-8c35-958c8103a2c529
1666622baclofen 10 MG per 5 ML (2,000 MCG/ML) InjectionSY6f3bdcc0-ffc8-4911-8c35-958c8103a2c529
308517baclofen 10,000 MCG per 20 ML InjectionSY6f3bdcc0-ffc8-4911-8c35-958c8103a2c529
1666613baclofen 40,000 MCG per 20 ML InjectionSY6f3bdcc0-ffc8-4911-8c35-958c8103a2c529
308516baclofen 50 MCG per 1 ML InjectionSY6f3bdcc0-ffc8-4911-8c35-958c8103a2c529
805679Lioresal 0.05 MG per 1 ML InjectionSY6f3bdcc0-ffc8-4911-8c35-958c8103a2c529
805678Lioresal 10 MG per 20 ML (500 MCG/ML) InjectionSY6f3bdcc0-ffc8-4911-8c35-958c8103a2c529
1666623Lioresal 10 MG per 5 ML (2,000 MCG/ML) InjectionSY6f3bdcc0-ffc8-4911-8c35-958c8103a2c529
1666620Lioresal 40 MG per 20 ML (2,000 MCG/ML) InjectionSY6f3bdcc0-ffc8-4911-8c35-958c8103a2c529
805679Lioresal 50 MCG per 1 ML InjectionSY6f3bdcc0-ffc8-4911-8c35-958c8103a2c529

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70121-2496-5701212496055 AMPULE in 1 BOX (70121-2496-5) / 1 mL in 1 AMPULE5 ampule2022-06-12NoNoHistorical