FDA.reportPublic FDA data

Baclofen

Product NDC
63187-274
11-digit product format
631870274
Labeler code
63187
Product ID
63187-274_8ef3522a-3a22-4d52-852d-a18f5a78f482
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Baclofen
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA072235
Marketing category
ANDA
Marketing start
1988-07-21
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
63187-274-30Baclofen30 in 1 BOTTLETABLET305
63187-274-60Baclofen60 in 1 BOTTLETABLET605
63187-274-90Baclofen90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-274-30EA - Each63187-274c0b003d2-d933-4cb3-ac64-4f69560b627712023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-274BACLOFEN TABLET [PROFICIENT RX LP]5Current NDC, Legacy NDC, 3 package rows20241024_9d5a10cf-9a99-41eb-b4b8-9cf4cfaff6fc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197392baclofen 20 MG Oral TabletPSN9d5a10cf-9a99-41eb-b4b8-9cf4cfaff6fc5
197392baclofen 20 MG Oral TabletSCD9d5a10cf-9a99-41eb-b4b8-9cf4cfaff6fc5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-274-306318702743030 TABLET in 1 BOTTLE (63187-274-30) 30 tablet2014-11-210000-00-00NoNoCurrent
63187-274-606318702746060 TABLET in 1 BOTTLE (63187-274-60) 60 tablet2014-11-210000-00-00NoNoCurrent
63187-274-906318702749090 TABLET in 1 BOTTLE (63187-274-90) 90 tablet2014-11-210000-00-00NoNoCurrent