Baclofen

Product NDC
68071-2414
11-digit product format
680712414
Labeler code
68071
Product ID
68071-2414_e6607b0c-7d83-22cb-e053-2995a90acc76
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Baclofen
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA212378
Marketing category
ANDA
Marketing start
2020-10-09
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 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
68071-2414-32025-01-30C16284748780-12cef2736-7b39-d83d-e063-dadaa90ab31fBaclofen Tablets, USP Rx only
68071-2414-42025-01-30C16284748780-12cef2736-7b39-d83d-e063-dadaa90ab31fBaclofen Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2414-3Baclofen30 in 1 BOTTLETABLET302
68071-2414-4Baclofen40 in 1 BOTTLETABLET402

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2414BACLOFEN TABLET [NUCARE PHARMACEUTICALS,INC.]2Legacy NDC, 2 package rows20220818_c31518c9-b3b5-acc7-e053-2995a90a27d9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197391baclofen 10 MG Oral TabletPSNc31518c9-b3b5-acc7-e053-2995a90a27d92
197391baclofen 10 MG Oral TabletSCDc31518c9-b3b5-acc7-e053-2995a90a27d92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2414-36807124140330 TABLET in 1 BOTTLE (68071-2414-3) 30 tablet2021-05-240000-00-00NoNoCurrent
68071-2414-46807124140440 TABLET in 1 BOTTLE (68071-2414-4) 40 tablet2021-05-240000-00-00NoNoCurrent