FDA.reportPublic FDA data

Baclofen

Product NDC
50090-6868
11-digit product format
500906868
Labeler code
50090
Product ID
50090-6868_c472fde4-c4d2-4ae7-978a-469fbc5ebe2e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Baclofen
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA074584
Marketing category
ANDA
Marketing start
2010-10-20
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
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
BACLOFEN10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiH789N3FKE8
Rxcui197391

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
50090-6868-0Baclofen60 in 1 BOTTLETABLET601
50090-6868-1Baclofen30 in 1 BOTTLETABLET301
50090-6868-3Baclofen90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6868-0EA - Each50090-6868f78f9006-93fc-42e1-9963-f4e331209f9d12024-02-14
50090-6868-1EA - Each50090-68686d191a5b-2352-4848-a384-30403349d12f12024-02-14
50090-6868-3EA - Each50090-6868877ee6ba-1196-4a42-822c-e26f60c7588c12024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6868BACLOFEN TABLET [A-S MEDICATION SOLUTIONS]1Current NDC, 3 package rows20231207_081d478a-2f3f-456e-bcca-00487589da6f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197391baclofen 10 MG Oral TabletPSN081d478a-2f3f-456e-bcca-00487589da6f1
197391baclofen 10 MG Oral TabletSCD081d478a-2f3f-456e-bcca-00487589da6f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6868-05009068680060 TABLET in 1 BOTTLE (50090-6868-0) 60 tablet2023-12-04NoNoCurrent
50090-6868-15009068680130 TABLET in 1 BOTTLE (50090-6868-1) 30 tablet2023-12-04NoNoCurrent
50090-6868-35009068680390 TABLET in 1 BOTTLE (50090-6868-3) 90 tablet2023-12-04NoNoCurrent