FDA.reportPublic FDA data

Baclofen

Product NDC
72189-504
11-digit product format
721890504
Labeler code
72189
Product ID
72189-504_2cc664b1-d3fd-fefa-e063-6294a90affa9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Baclofen
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA209102
Marketing category
ANDA
Marketing start
2023-08-03
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Baclofen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACLOFEN20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiH789N3FKE8
Rxcui197392

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-504-30Baclofen30 in 1 BOTTLETABLET304
72189-504-60Baclofen60 in 1 BOTTLETABLET604
72189-504-82Baclofen180 in 1 BOTTLETABLET1804
72189-504-90Baclofen90 in 1 BOTTLETABLET904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-504BACLOFEN TABLET [DIRECT_RX]4Current NDC, 4 package rows20250130_020632f4-5e8a-f4a0-e063-6294a90a6301.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197392baclofen 20 MG Oral TabletPSN020632f4-5e8a-f4a0-e063-6294a90a63014
197392baclofen 20 MG Oral TabletSCD020632f4-5e8a-f4a0-e063-6294a90a63014

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72189-504-307218905043030 TABLET in 1 BOTTLE (72189-504-30) 30 tablet2023-08-03NoNoCurrent
72189-504-607218905046060 TABLET in 1 BOTTLE (72189-504-60) 60 tablet2023-08-03NoNoCurrent
72189-504-8272189050482180 TABLET in 1 BOTTLE (72189-504-82) 180 tablet2023-08-03NoNoCurrent
72189-504-907218905049090 TABLET in 1 BOTTLE (72189-504-90) 90 tablet2023-08-03NoNoCurrent