FDA.reportPublic FDA data

Baclofen

Product NDC
50090-4682
11-digit product format
500904682
Labeler code
50090
Product ID
50090-4682_0825b008-5a6d-4ad7-8cdb-73ebb6692302
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Baclofen
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA211659
Marketing category
ANDA
Marketing start
2018-12-06
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
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4682-02023-02-07C16284748780-1f386c649-dc05-0266-e053-dadaa90a7c1aBACLOFEN TABLETS USP Rx only
50090-4682-12023-02-07C16284748780-1f386c649-dc05-0266-e053-dadaa90a7c1aBACLOFEN TABLETS USP Rx only
50090-4682-22023-02-07C16284748780-1f386c649-dc05-0266-e053-dadaa90a7c1aBACLOFEN TABLETS USP Rx only
50090-4682-32023-02-07C16284748780-1f386c649-dc05-0266-e053-dadaa90a7c1aBACLOFEN TABLETS USP Rx only
50090-4682-02023-01-30C16284748780-1f386c649-dc05-0266-e053-dadaa90a7c1aBACLOFEN TABLETS USP Rx only
50090-4682-12023-01-30C16284748780-1f386c649-dc05-0266-e053-dadaa90a7c1aBACLOFEN TABLETS USP Rx only
50090-4682-22023-01-30C16284748780-1f386c649-dc05-0266-e053-dadaa90a7c1aBACLOFEN TABLETS USP Rx only
50090-4682-32023-01-30C16284748780-1f386c649-dc05-0266-e053-dadaa90a7c1aBACLOFEN TABLETS USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4682-0Baclofen20 in 1 BOTTLETABLET2012
50090-4682-1Baclofen60 in 1 BOTTLETABLET6012
50090-4682-2Baclofen30 in 1 BOTTLETABLET3012
50090-4682-3Baclofen90 in 1 BOTTLETABLET9012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4682BACLOFEN TABLET [A-S MEDICATION SOLUTIONS]10Current NDC, Legacy NDC, 4 package rows20240430_975fda6d-d929-482b-8be7-60849026dbdd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197392baclofen 20 MG Oral TabletPSN975fda6d-d929-482b-8be7-60849026dbdd12
197392baclofen 20 MG Oral TabletSCD975fda6d-d929-482b-8be7-60849026dbdd12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4682-05009046820020 TABLET in 1 BOTTLE (50090-4682-0) 20 tablet2019-11-040000-00-00NoNoCurrent
50090-4682-15009046820160 TABLET in 1 BOTTLE (50090-4682-1) 60 tablet2019-11-040000-00-00NoNoCurrent
50090-4682-25009046820230 TABLET in 1 BOTTLE (50090-4682-2) 30 tablet2019-11-040000-00-00NoNoCurrent
50090-4682-35009046820390 TABLET in 1 BOTTLE (50090-4682-3) 90 tablet2019-11-040000-00-00NoNoCurrent