BACLOFEN

Product NDC
55700-974
11-digit product format
557000974
Labeler code
55700
Product ID
55700-974_47d1cae6-516f-42a7-838b-c97715f9f2e9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BACLOFEN
Dosage form
TABLET
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA214099
Marketing category
ANDA
Marketing start
2022-06-07
Marketing end
0000-00-00
Substance
BACLOFEN
Active strength
10 mg/1
Pharmacologic classes
GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-974-01EA - Each55700-9749b785085-5399-42dd-9ff7-f9084fe9a90f12022-12-07
55700-974-30EA - Each55700-97483ca0ebc-c050-4e76-893d-934580ea64e712022-09-12
55700-974-60EA - Each55700-974d3d42696-2c68-4ba9-be93-926cc89cd7a812023-01-09
55700-974-90EA - Each55700-974dd79c886-73a3-4c09-adf7-7f274903874712023-01-09

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-974-0155700097401120 TABLET in 1 BOTTLE (55700-974-01) 120 tablet2022-11-030000-00-00NoNoCurrent
55700-974-305570009743030 TABLET in 1 BOTTLE (55700-974-30) 30 tablet2022-06-070000-00-00NoNoCurrent
55700-974-605570009746060 TABLET in 1 BOTTLE (55700-974-60) 60 tablet2022-12-220000-00-00NoNoCurrent
55700-974-905570009749090 TABLET in 1 BOTTLE (55700-974-90) 90 tablet2022-12-220000-00-00NoNoCurrent