FDA.reportPublic FDA data

Baclofen

Product NDC
42571-429
11-digit product format
425710429
Labeler code
42571
Product ID
42571-429_0acb9150-3e4c-9f37-e063-6294a90a7fd6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Baclofen
Dosage form
TABLET
Route
ORAL
Labeler
Micro Labs Limited
Application
ANDA217687
Marketing category
ANDA
Marketing start
2024-04-01
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
Rxcui197391, 197392, 430902

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
42571-429-01Baclofen100 in 1 BOTTLETABLET1001
42571-429-05Baclofen500 in 1 BOTTLETABLET5001
42571-429-13Baclofen1000 in 1 BOTTLETABLET10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42571-429BACLOFEN TABLET [MICRO LABS LIMITED]1Current NDC, 3 package rows20240402_f0abf768-3b19-452b-b56d-eb70441cfb18.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197391baclofen 10 MG Oral TabletPSNf0abf768-3b19-452b-b56d-eb70441cfb181
197392baclofen 20 MG Oral TabletPSNf0abf768-3b19-452b-b56d-eb70441cfb181
430902baclofen 5 MG Oral TabletPSNf0abf768-3b19-452b-b56d-eb70441cfb181
197391baclofen 10 MG Oral TabletSCDf0abf768-3b19-452b-b56d-eb70441cfb181
197392baclofen 20 MG Oral TabletSCDf0abf768-3b19-452b-b56d-eb70441cfb181
430902baclofen 5 MG Oral TabletSCDf0abf768-3b19-452b-b56d-eb70441cfb181

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42571-429-0142571042901100 TABLET in 1 BOTTLE (42571-429-01) 100 tablet2024-04-01NoNoCurrent
42571-429-0542571042905500 TABLET in 1 BOTTLE (42571-429-05) 500 tablet2024-04-01NoNoCurrent
42571-429-13425710429131000 TABLET in 1 BOTTLE (42571-429-13) 1000 tablet2024-04-01NoNoCurrent