Lioresal (baclofen)

Product NDC
70257-561
11-digit product format
702570561
Labeler code
70257
Product ID
70257-561_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
10 mg/5mL
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
70257-561-02ML - Milliliter70257-561f0f8ea41-998e-4b05-b7de-97825034223c12018-02-20
70257-561-05ML - Milliliter70257-5614ca4fc09-f5d6-4a98-90b7-777acabceca012019-04-11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70257-561-02702570561022 AMPULE in 1 BOX (70257-561-02) > 5 mL in 1 AMPULE (70257-561-05) 2 ampule2022-01-030000-00-00NoNoCurrent