Baclofen

Product NDC
17856-1024
11-digit product format
178561024
Labeler code
17856
Product ID
17856-1024_c033a166-a47c-4971-a9e5-34d8431fd3b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Baclofen
Dosage form
TABLET
Route
ORAL
Labeler
Atlantic Biologicals Corps
Application
ANDA074584
Marketing category
ANDA
Marketing start
2010-10-20
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
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e25d01b-2e92-4765-bec7-8a0fd7bdc346Product name220251208
1b1393e5-f2d8-42f5-a070-e3416d619667Product name120250804
88583480-702d-4dfe-a31c-9c00abd818f8Product name720250729
1cf3c538-592e-4b4b-869e-51d4bf3ca83dProduct name220240703
6e532d1f-e0b5-46eb-a2be-d70bd338df9dProduct name120220613
ef6bc0bf-8134-f06b-70d9-4980df6f808eProduct name520210615
eeec0918-7a2f-44bf-83d6-1216e507adbfProduct name320191217
a5300adb-f538-4abb-a49e-f8f0b8d9ac75Product name120190611

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-1024-12020-01-31C16284748780-19d75b9d0-8e21-f424-e053-dadaa90a57ceBACLOFEN TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-1024-1Baclofen100 in 1 CASETABLET1002
17856-1024-1Baclofen1 in 1 POUCHTABLET12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-1024BACLOFEN TABLET [ATLANTIC BIOLOGICALS CORPS]2Legacy NDC, 2 package rows20161130_ada5c3a9-ad1e-4351-aab2-8f93386b7fe4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197391baclofen 10 MG Oral TabletPSNada5c3a9-ad1e-4351-aab2-8f93386b7fe42
197391baclofen 10 MG Oral TabletSCDada5c3a9-ad1e-4351-aab2-8f93386b7fe42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
17856-1024-117856102401100 in 1 CASEHistorical