FDA.reportPublic FDA data

Baclofen

Product NDC
80425-0282
11-digit product format
804250282
Labeler code
80425
Product ID
80425-0282_26f8bbf8-7c53-4c19-e063-6394a90a5a4a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Baclofen
Dosage form
TABLET
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA212378
Marketing category
ANDA
Marketing start
2020-10-09
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
80425-0282-1Baclofen30 in 1 BOTTLETABLET302
80425-0282-2Baclofen60 in 1 BOTTLETABLET602
80425-0282-3Baclofen90 in 1 BOTTLETABLET902
80425-0282-4Baclofen120 in 1 BOTTLETABLET1202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0282-1EA - Each80425-02826dc60c48-2657-425f-bc48-f4f28897157712023-04-07
80425-0282-2EA - Each80425-028242f8d368-b537-40b6-9557-e8544b27c1ca12023-04-07
80425-0282-3EA - Each80425-0282b6333d87-6abb-4774-9644-0242ac576cf112023-04-07
80425-0282-4EA - Each80425-0282f179f3fc-b772-4532-8048-9a3dba92b73c12024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0282BACLOFEN TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 4 package rows20241116_f5edb656-4f7e-2386-e053-2995a90a70de.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197392baclofen 20 MG Oral TabletPSNf5edb656-4f7e-2386-e053-2995a90a70de2
197392baclofen 20 MG Oral TabletSCDf5edb656-4f7e-2386-e053-2995a90a70de2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0282-18042502820130 TABLET in 1 BOTTLE (80425-0282-1) 30 tablet2020-10-09NoNoHistorical
80425-0282-28042502820260 TABLET in 1 BOTTLE (80425-0282-2) 60 tablet2020-10-09NoNoHistorical
80425-0282-38042502820390 TABLET in 1 BOTTLE (80425-0282-3) 90 tablet2020-10-09NoNoHistorical
80425-0282-480425028204120 TABLET in 1 BOTTLE (80425-0282-4) 120 tablet2024-11-15NoNoHistorical