BACLOFEN

Product NDC
61919-027
11-digit product format
619190027
Labeler code
61919
Product ID
61919-027_9c5970fb-9bc3-6e87-e053-2a95a90a6889
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BACLOFEN
Dosage form
TABLET
Route
ORAL
Labeler
Direct Rx
Application
ANDA072235
Marketing category
ANDA
Marketing start
2014-01-01
Marketing end
0000-00-00
Substance
BACLOFEN
Active strength
20 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
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-027-902023-02-02C16284748780-1f386c649-d4a8-0266-e053-dadaa90a7c1aBACLOFEN
61919-027-902023-01-30C16284748780-1f386c649-d4a8-0266-e053-dadaa90a7c1aBACLOFEN

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-027-30EA - Each61919-02700360b49-8e29-45f5-90f7-19aa01f6593d12015-10-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-027-906191900279090 BOTTLE in 1 BOTTLE (61919-027-90) > 60 BOTTLE in 1 BOTTLE (61919-027-60) > 30 TABLET in 1 BOTTLE (61919-027-30) 90 bottle2015-01-010000-00-00NoNoCurrent