Baclofen

Product NDC
80175-0006
11-digit product format
801750006
Labeler code
80175
Product ID
80175-0006_bbf3a739-13d8-4667-e053-2a95a90a1eca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Baclofen
Dosage form
TABLET
Route
ORAL
Labeler
Central Packaging
Application
ANDA211555
Marketing category
ANDA
Marketing start
2020-01-10
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
2022-12-31
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
80175-0006-32021-07-23C16284748780-1c7ccaba7-18c9-fd44-e053-dadaa90aa01bbbf3a739-13d7-4667-e053-2a95a90a1eca

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80175-0006-3Baclofen30 in 1 BOTTLETABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80175-0006BACLOFEN TABLET [CENTRAL PACKAGING]1Legacy NDC, 1 package rows20210223_bbf3a739-13d7-4667-e053-2a95a90a1eca.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197391baclofen 10 MG Oral TabletPSNbbf3a739-13d7-4667-e053-2a95a90a1eca1
197391baclofen 10 MG Oral TabletSCDbbf3a739-13d7-4667-e053-2a95a90a1eca1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80175-0006-38017500060330 TABLET in 1 BOTTLE (80175-0006-3) 30 tablet2020-01-100000-00-00NoNoCurrent