FDA.reportPublic FDA data

BACLOFEN

Product NDC
80425-0568
11-digit product format
804250568
Labeler code
80425
Product ID
80425-0568_46416b23-1e60-f4e3-e063-6294a90a953f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BACLOFEN
Dosage form
TABLET
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA209102
Marketing category
ANDA
Marketing start
2025-12-10
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
80425-0568-1BACLOFEN30 in 1 BOTTLE, PLASTICTABLET302
80425-0568-2BACLOFEN60 in 1 BOTTLE, PLASTICTABLET602
80425-0568-3BACLOFEN90 in 1 BOTTLE, PLASTICTABLET902
80425-0568-4BACLOFEN120 in 1 BOTTLE, PLASTICTABLET1202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0568-1EA - Each80425-0568fd62f69c-ac76-4e03-a37d-81d0ded4e8c012026-01-08
80425-0568-2EA - Each80425-0568e8b031f4-bf7a-42cd-a4a5-606a9d0bba0112026-01-08
80425-0568-3EA - Each80425-0568da369a76-fc7c-488a-b4c7-08963996f3be12026-01-08
80425-0568-4EA - Each80425-0568461a6be2-b99d-4b7b-b3a2-ccc8e8f3654712026-01-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197391baclofen 10 MG Oral TabletPSN459ec5f5-4f99-e917-e063-6294a90a23cd2
197391baclofen 10 MG Oral TabletSCD459ec5f5-4f99-e917-e063-6294a90a23cd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0568-18042505680130 TABLET in 1 BOTTLE, PLASTIC (80425-0568-1) 30 tablet2025-12-10NoNoHistorical
80425-0568-28042505680260 TABLET in 1 BOTTLE, PLASTIC (80425-0568-2) 60 tablet2025-12-10NoNoHistorical
80425-0568-38042505680390 TABLET in 1 BOTTLE, PLASTIC (80425-0568-3) 90 tablet2025-12-10NoNoHistorical
80425-0568-480425056804120 TABLET in 1 BOTTLE, PLASTIC (80425-0568-4) 120 tablet2025-12-10NoNoHistorical