FDA.reportPublic FDA data

BACLOFEN

Product NDC
68788-8584
11-digit product format
687888584
Labeler code
68788
Product ID
68788-8584_ea43d377-0a64-4c3b-8c1d-7b1400ba3945
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BACLOFEN
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA214099
Marketing category
ANDA
Marketing start
2024-02-15
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
68788-8584-1BACLOFEN100 in 1 BOTTLETABLET1003
68788-8584-3BACLOFEN30 in 1 BOTTLETABLET303
68788-8584-6BACLOFEN60 in 1 BOTTLETABLET603
68788-8584-8BACLOFEN120 in 1 BOTTLETABLET1203
68788-8584-9BACLOFEN90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8584-1EA - Each68788-858456444dc6-094f-4317-8971-2fad4f091cde12024-05-16
68788-8584-3EA - Each68788-8584f81c250b-a40f-4b99-9c5c-e403fa66a4a012024-05-16
68788-8584-6EA - Each68788-85845bf71ce5-8235-4f9d-942b-5f2f32b9db4112024-05-16
68788-8584-8EA - Each68788-8584ef61a7be-af00-45ce-afbc-0784fadb2a9512024-05-16
68788-8584-9EA - Each68788-85846420c134-676d-4f1b-aac8-301beeff623e12024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8584BACLOFEN TABLET [PREFERRED PHARMACEUTICALS INC.]2Current NDC, 5 package rows20250124_3fdfeef9-68b3-4f6c-a4de-28179758a962.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197391baclofen 10 MG Oral TabletPSN3fdfeef9-68b3-4f6c-a4de-28179758a9623
197391baclofen 10 MG Oral TabletSCD3fdfeef9-68b3-4f6c-a4de-28179758a9623

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8584-168788858401100 TABLET in 1 BOTTLE (68788-8584-1) 100 tablet2024-02-15NoNoCurrent
68788-8584-36878885840330 TABLET in 1 BOTTLE (68788-8584-3) 30 tablet2024-02-15NoNoCurrent
68788-8584-66878885840660 TABLET in 1 BOTTLE (68788-8584-6) 60 tablet2024-02-15NoNoCurrent
68788-8584-868788858408120 TABLET in 1 BOTTLE (68788-8584-8) 120 tablet2024-02-15NoNoCurrent
68788-8584-96878885840990 TABLET in 1 BOTTLE (68788-8584-9) 90 tablet2024-02-15NoNoCurrent