Lioresal (baclofen)

Product NDC
70257-560
11-digit product format
702570560
Labeler code
70257
Product ID
70257-560_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/20mL
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
70257-560-01ML - Milliliter70257-5605afcac42-845e-466d-83c0-93d54d4b43db12018-02-20
70257-560-02ML - Milliliter70257-560eb8e0807-53da-48e3-8927-f2caff1ed04a12018-02-20
70257-560-20ML - Milliliter70257-5608d44aafa-27dd-4566-8375-0c481b7f657912019-09-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70257-560-01702570560011 AMPULE in 1 BOX (70257-560-01) > 20 mL in 1 AMPULE (70257-560-20) 1 ampule2022-01-030000-00-00NoNoCurrent
70257-560-02702570560022 AMPULE in 1 BOX (70257-560-02) > 20 mL in 1 AMPULE (70257-560-20) 2 ampule2022-01-030000-00-00NoNoCurrent