BACLOFEN

Product NDC
68071-2841
11-digit product format
680712841
Labeler code
68071
Product ID
68071-2841_f1735ff3-682e-3f19-e053-2a95a90aadda
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BACLOFEN
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA214099
Marketing category
ANDA
Marketing start
2021-07-13
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
2024-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2841-3BACLOFEN30 in 1 BOTTLETABLET303
68071-2841-4BACLOFEN40 in 1 BOTTLETABLET403
68071-2841-6BACLOFEN60 in 1 BOTTLETABLET603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2841BACLOFEN TABLET [NUCARE PHARMACEUTICALS,INC.]3Legacy NDC, 3 package rows20230608_ea52170c-7986-21bd-e053-2a95a90a5dff.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197391baclofen 10 MG Oral TabletPSNea52170c-7986-21bd-e053-2a95a90a5dff3
197391baclofen 10 MG Oral TabletSCDea52170c-7986-21bd-e053-2a95a90a5dff3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2841-36807128410330 TABLET in 1 BOTTLE (68071-2841-3) 30 tablet2022-01-040000-00-00NoNoCurrent
68071-2841-46807128410440 TABLET in 1 BOTTLE (68071-2841-4) 40 tablet2022-10-050000-00-00NoNoCurrent
68071-2841-66807128410660 in 1 BOTTLEHistorical