Baclofen

Product NDC
71335-1664
11-digit product format
713351664
Labeler code
71335
Product ID
71335-1664_7f9282e0-a178-48fe-99db-bc10ea061f6f
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
20 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
71335-1664-0Baclofen120 in 1 BOTTLETABLET1203
71335-1664-1Baclofen90 in 1 BOTTLETABLET903
71335-1664-2Baclofen20 in 1 BOTTLETABLET203
71335-1664-3Baclofen60 in 1 BOTTLETABLET603
71335-1664-4Baclofen45 in 1 BOTTLETABLET453
71335-1664-5Baclofen112 in 1 BOTTLETABLET1123
71335-1664-6Baclofen30 in 1 BOTTLETABLET303
71335-1664-7Baclofen56 in 1 BOTTLETABLET563
71335-1664-8Baclofen15 in 1 BOTTLETABLET153
71335-1664-9Baclofen84 in 1 BOTTLETABLET843

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1664BACLOFEN TABLET [BRYANT RANCH PREPACK]3Legacy NDC, 10 package rows20220521_aeb56b0e-7126-4417-b726-e8a54f73de3f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197392baclofen 20 MG Oral TabletPSNaeb56b0e-7126-4417-b726-e8a54f73de3f3
197392baclofen 20 MG Oral TabletSCDaeb56b0e-7126-4417-b726-e8a54f73de3f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1664-071335166400120 TABLET in 1 BOTTLE (71335-1664-0) 120 tablet2020-08-270000-00-00NoNoCurrent
71335-1664-17133516640190 TABLET in 1 BOTTLE (71335-1664-1) 90 tablet2022-04-290000-00-00NoNoCurrent
71335-1664-27133516640220 TABLET in 1 BOTTLE (71335-1664-2) 20 tablet2022-02-150000-00-00NoNoCurrent
71335-1664-37133516640360 TABLET in 1 BOTTLE (71335-1664-3) 60 tablet2020-09-110000-00-00NoNoCurrent
71335-1664-47133516640445 TABLET in 1 BOTTLE (71335-1664-4) 45 tablet2022-02-150000-00-00NoNoCurrent
71335-1664-571335166405112 TABLET in 1 BOTTLE (71335-1664-5) 112 tablet2022-02-150000-00-00NoNoCurrent
71335-1664-67133516640630 TABLET in 1 BOTTLE (71335-1664-6) 30 tablet2020-07-150000-00-00NoNoCurrent
71335-1664-77133516640756 TABLET in 1 BOTTLE (71335-1664-7) 56 tablet2020-07-150000-00-00NoNoCurrent
71335-1664-87133516640815 TABLET in 1 BOTTLE (71335-1664-8) 15 tablet2020-07-150000-00-00NoNoCurrent
71335-1664-97133516640984 TABLET in 1 BOTTLE (71335-1664-9) 84 tablet2020-07-150000-00-00NoNoCurrent