Baclofen

Product NDC
71335-1643
11-digit product format
713351643
Labeler code
71335
Product ID
71335-1643_6844d3f9-01ea-428c-bb38-7f13ebf15ec9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Baclofen
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA211555
Marketing category
ANDA
Marketing start
2021-05-27
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1643-0Baclofen112 in 1 BOTTLETABLET1123
71335-1643-1Baclofen30 in 1 BOTTLETABLET303
71335-1643-2Baclofen120 in 1 BOTTLETABLET1203
71335-1643-3Baclofen20 in 1 BOTTLETABLET203
71335-1643-4Baclofen60 in 1 BOTTLETABLET603
71335-1643-5Baclofen100 in 1 BOTTLETABLET1003
71335-1643-6Baclofen56 in 1 BOTTLETABLET563
71335-1643-7Baclofen90 in 1 BOTTLETABLET903
71335-1643-8Baclofen140 in 1 BOTTLETABLET1403
71335-1643-9Baclofen84 in 1 BOTTLETABLET843

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1643BACLOFEN TABLET [BRYANT RANCH PREPACK]3Legacy NDC, 10 package rows20220520_c6a066e5-69e9-4d08-90d9-072840bd438f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197391baclofen 10 MG Oral TabletPSNc6a066e5-69e9-4d08-90d9-072840bd438f3
197391baclofen 10 MG Oral TabletSCDc6a066e5-69e9-4d08-90d9-072840bd438f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1643-071335164300112 TABLET in 1 BOTTLE (71335-1643-0) 112 tablet2022-02-140000-00-00NoNoCurrent
71335-1643-17133516430130 TABLET in 1 BOTTLE (71335-1643-1) 30 tablet2020-06-160000-00-00NoNoCurrent
71335-1643-271335164302120 TABLET in 1 BOTTLE (71335-1643-2) 120 tablet2020-08-050000-00-00NoNoCurrent
71335-1643-37133516430320 TABLET in 1 BOTTLE (71335-1643-3) 20 tablet2020-06-150000-00-00NoNoCurrent
71335-1643-47133516430460 TABLET in 1 BOTTLE (71335-1643-4) 60 tablet2022-02-140000-00-00NoNoCurrent
71335-1643-571335164305100 TABLET in 1 BOTTLE (71335-1643-5) 100 tablet2022-02-140000-00-00NoNoCurrent
71335-1643-67133516430656 TABLET in 1 BOTTLE (71335-1643-6) 56 tablet2022-04-290000-00-00NoNoCurrent
71335-1643-77133516430790 TABLET in 1 BOTTLE (71335-1643-7) 90 tablet2022-04-290000-00-00NoNoCurrent
71335-1643-871335164308140 TABLET in 1 BOTTLE (71335-1643-8) 140 tablet2022-04-290000-00-00NoNoCurrent
71335-1643-97133516430984 TABLET in 1 BOTTLE (71335-1643-9) 84 tablet2022-04-290000-00-00NoNoCurrent