FDA.reportPublic FDA data

BACLOFEN

Product NDC
68788-8726
11-digit product format
687888726
Labeler code
68788
Product ID
68788-8726_14664cc5-700a-44e4-bd73-b8f4cbd8c1e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BACLOFEN
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA214374
Marketing category
ANDA
Marketing start
2024-08-16
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
68788-8726-1BACLOFEN100 in 1 BOTTLETABLET1003
68788-8726-3BACLOFEN30 in 1 BOTTLETABLET303
68788-8726-6BACLOFEN60 in 1 BOTTLETABLET603
68788-8726-8BACLOFEN120 in 1 BOTTLETABLET1203
68788-8726-9BACLOFEN90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8726-1EA - Each68788-8726c36125dd-9ee5-4cbd-a944-51ddc95fb4d812024-10-04
68788-8726-3EA - Each68788-8726bc5d1b16-f825-4ddc-97f7-a07e279b76e812024-10-04
68788-8726-6EA - Each68788-8726afb1de45-ba08-4ee6-9566-1fc65a269db512024-10-04
68788-8726-8EA - Each68788-87266811b6e5-51a4-43c1-88f1-111a6993d22e12024-10-04
68788-8726-9EA - Each68788-87260e358f56-61c0-4dd0-a708-b3bccefd2ed512024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8726BACLOFEN TABLET [PREFERRED PHARMACEUTICALS INC.]2Current NDC, 5 package rows20250125_5e479876-adfb-4590-ac10-3924ff7988b0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197391baclofen 10 MG Oral TabletPSN5e479876-adfb-4590-ac10-3924ff7988b03
197391baclofen 10 MG Oral TabletSCD5e479876-adfb-4590-ac10-3924ff7988b03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8726-168788872601100 TABLET in 1 BOTTLE (68788-8726-1) 100 tablet2024-08-16NoNoHistorical
68788-8726-36878887260330 TABLET in 1 BOTTLE (68788-8726-3) 30 tablet2024-08-16NoNoHistorical
68788-8726-66878887260660 TABLET in 1 BOTTLE (68788-8726-6) 60 tablet2024-08-16NoNoHistorical
68788-8726-868788872608120 TABLET in 1 BOTTLE (68788-8726-8) 120 tablet2024-08-16NoNoHistorical
68788-8726-96878887260990 TABLET in 1 BOTTLE (68788-8726-9) 90 tablet2024-08-16NoNoHistorical