FDA.reportPublic FDA data

Baclofen

Product NDC
68788-8783
11-digit product format
687888783
Labeler code
68788
Product ID
68788-8783_f7ff76a5-0d29-4d3e-849b-786635638812
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Baclofen
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA212067
Marketing category
ANDA
Marketing start
2024-12-11
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

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
68788-8783-1Baclofen100 in 1 BOTTLETABLET1002
68788-8783-3Baclofen30 in 1 BOTTLETABLET302
68788-8783-6Baclofen60 in 1 BOTTLETABLET602
68788-8783-8Baclofen120 in 1 BOTTLETABLET1202
68788-8783-9Baclofen90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8783-1EA - Each68788-8783cede6b4f-3058-46ba-914e-965a5bb5423112025-01-14
68788-8783-3EA - Each68788-87835a0be433-38fc-4d42-bacd-d5444209411012025-01-14
68788-8783-6EA - Each68788-87833b4a12de-f902-4deb-9d16-3242505ee94e12025-01-14
68788-8783-8EA - Each68788-878326a66efe-b2b6-46e4-b58e-de6fa27b72c012025-01-14
68788-8783-9EA - Each68788-8783fd12beb0-ac3a-4734-9c47-9389d0b3c69a12025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8783BACLOFEN TABLET [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 5 package rows20241213_69d0027a-cb46-4754-9225-071ec1ce4b37.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197391baclofen 10 MG Oral TabletPSN69d0027a-cb46-4754-9225-071ec1ce4b372
197391baclofen 10 MG Oral TabletSCD69d0027a-cb46-4754-9225-071ec1ce4b372

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8783-168788878301100 TABLET in 1 BOTTLE (68788-8783-1) 100 tablet2024-12-11NoNoHistorical
68788-8783-36878887830330 TABLET in 1 BOTTLE (68788-8783-3) 30 tablet2024-12-11NoNoHistorical
68788-8783-66878887830660 TABLET in 1 BOTTLE (68788-8783-6) 60 tablet2024-12-11NoNoHistorical
68788-8783-868788878308120 TABLET in 1 BOTTLE (68788-8783-8) 120 tablet2024-12-11NoNoHistorical
68788-8783-96878887830990 TABLET in 1 BOTTLE (68788-8783-9) 90 tablet2024-12-11NoNoHistorical