FDA.reportPublic FDA data

BACLOFEN

Product NDC
80425-0466
11-digit product format
804250466
Labeler code
80425
Product ID
80425-0466_2a73e629-f016-d23f-e063-6394a90ac1fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BACLOFEN
Dosage form
TABLET
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA214099
Marketing category
ANDA
Marketing start
2024-12-28
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
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
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
80425-0466-1BACLOFEN30 in 1 BOTTLETABLET302
80425-0466-2BACLOFEN60 in 1 BOTTLETABLET602
80425-0466-3BACLOFEN90 in 1 BOTTLETABLET902
80425-0466-4BACLOFEN120 in 1 BOTTLETABLET1202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0466-1EA - Each80425-046699491281-fae8-4f83-9826-3868e26b6a0012025-02-10
80425-0466-2EA - Each80425-04663317968b-3a2a-41c3-831a-dc12ef1a190212025-02-10
80425-0466-3EA - Each80425-0466a0826932-5a6a-4669-8833-f9a34b4cfac912025-02-10
80425-0466-4EA - Each80425-04660f55c6eb-9b49-458d-823a-5c64d8fea7f112025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0466BACLOFEN TABLET [ADVANCED RX OF TENNESSEE, LLC]2Current NDC, 4 package rows20241231_2a58145a-57f9-6bb1-e063-6294a90a32a8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197392baclofen 20 MG Oral TabletPSN2a58145a-57f9-6bb1-e063-6294a90a32a82
197392baclofen 20 MG Oral TabletSCD2a58145a-57f9-6bb1-e063-6294a90a32a82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0466-18042504660130 TABLET in 1 BOTTLE (80425-0466-1) 30 tablet2024-12-28NoNoHistorical
80425-0466-28042504660260 TABLET in 1 BOTTLE (80425-0466-2) 60 tablet2024-12-28NoNoHistorical
80425-0466-38042504660390 TABLET in 1 BOTTLE (80425-0466-3) 90 tablet2024-12-28NoNoHistorical
80425-0466-480425046604120 TABLET in 1 BOTTLE (80425-0466-4) 120 tablet2024-12-28NoNoHistorical