Lioresal (baclofen)

Product NDC
70257-562
11-digit product format
702570562
Labeler code
70257
Product ID
70257-562_7280e190-0f51-11ed-aa05-0800200c9a66
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
baclofen
Dosage form
INJECTION
Route
INTRATHECAL
Labeler
Saol Therapeutics Inc.
Application
NDA020075
Marketing category
NDA
Marketing start
2022-06-12
Marketing end
2024-11-30
Substance
BACLOFEN
Active strength
0 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
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70257-562-11ML - Milliliter70257-5622e84ed73-0ede-4f12-abd4-c55e71c47eef12018-03-08
70257-562-55ML - Milliliter70257-5624fe84d4f-2558-42bd-b486-d58961f7b3dc12017-08-11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70257-562-55702570562555 AMPULE in 1 BOX (70257-562-55) > 1 mL in 1 AMPULE (70257-562-11) 5 ampule2022-01-030000-00-00NoNoCurrent