Baclofen

Product NDC
51407-973
11-digit product format
514070973
Labeler code
51407
Product ID
51407-973_5000db85-7b5f-8b15-e063-6294a90a96ce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Baclofen
Dosage form
TABLET
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA215885
Marketing category
ANDA
Marketing start
2022-01-25
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Baclofen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACLOFEN10 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
51407-973-01Baclofen100 in 1 BOTTLETABLET1002
51407-973-10Baclofen1000 in 1 BOTTLETABLET10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-973BACLOFEN TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1Current NDC, 2 package rows20250409_32336e92-89a4-7d7f-e063-6394a90ae924.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197391baclofen 10 MG Oral TabletPSN32336e92-89a4-7d7f-e063-6394a90ae9242
197392baclofen 20 MG Oral TabletPSN32336e92-89a4-7d7f-e063-6394a90ae9242
430902baclofen 5 MG Oral TabletPSN32336e92-89a4-7d7f-e063-6394a90ae9242
197391baclofen 10 MG Oral TabletSCD32336e92-89a4-7d7f-e063-6394a90ae9242
197392baclofen 20 MG Oral TabletSCD32336e92-89a4-7d7f-e063-6394a90ae9242
430902baclofen 5 MG Oral TabletSCD32336e92-89a4-7d7f-e063-6394a90ae9242
197391baclofen 10 MG Oral TabletPSN39ad22ca-f034-f605-e063-6294a90a08e41
197391baclofen 10 MG Oral TabletSCD39ad22ca-f034-f605-e063-6294a90a08e41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51407-973-0151407097301100 TABLET in 1 BOTTLE (51407-973-01) 100 tablet2025-03-14NoNoCurrent
51407-973-10514070973101000 TABLET in 1 BOTTLE (51407-973-10) 1000 tablet2025-03-14NoNoCurrent