FDA.reportPublic FDA data

BACLOFEN

Product NDC
68788-8737
11-digit product format
687888737
Labeler code
68788
Product ID
68788-8737_10d5e5c1-4b58-4d50-829e-a0b0ba3fec91
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BACLOFEN
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA214374
Marketing category
ANDA
Marketing start
2024-09-16
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8737-1BACLOFEN100 in 1 BOTTLETABLET1003
68788-8737-3BACLOFEN30 in 1 BOTTLETABLET303
68788-8737-6BACLOFEN60 in 1 BOTTLETABLET603
68788-8737-8BACLOFEN120 in 1 BOTTLETABLET1203
68788-8737-9BACLOFEN90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8737-1EA - Each68788-87376ace257b-2b6c-48b3-af3d-b723841865cb12024-11-05
68788-8737-3EA - Each68788-87375f68a5ed-fc78-4f61-8009-8c90934163ee12024-11-05
68788-8737-6EA - Each68788-8737a6e3b1d3-f922-4af4-ad26-d9943e500d8c12024-11-05
68788-8737-8EA - Each68788-8737a1f128eb-3245-4cfd-beb4-c84372139e4c12024-11-05
68788-8737-9EA - Each68788-873703462097-ef0a-45d6-a030-a92f1feff5ef12024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8737BACLOFEN TABLET [PREFERRED PHARMACEUTICALS INC.]2Current NDC, 5 package rows20250126_d20cc8b2-5236-4c87-b395-0acaaf7b62dd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197392baclofen 20 MG Oral TabletPSNd20cc8b2-5236-4c87-b395-0acaaf7b62dd3
197392baclofen 20 MG Oral TabletSCDd20cc8b2-5236-4c87-b395-0acaaf7b62dd3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8737-168788873701100 TABLET in 1 BOTTLE (68788-8737-1) 100 tablet2024-09-16NoNoHistorical
68788-8737-36878887370330 TABLET in 1 BOTTLE (68788-8737-3) 30 tablet2024-09-16NoNoHistorical
68788-8737-66878887370660 TABLET in 1 BOTTLE (68788-8737-6) 60 tablet2024-09-16NoNoHistorical
68788-8737-868788873708120 TABLET in 1 BOTTLE (68788-8737-8) 120 tablet2024-09-16NoNoHistorical
68788-8737-96878887370990 TABLET in 1 BOTTLE (68788-8737-9) 90 tablet2024-09-16NoNoHistorical