FDA.reportPublic FDA data

Baclofen

Product NDC
80425-0391
11-digit product format
804250391
Labeler code
80425
Product ID
80425-0391_19b02d44-fcc9-2e05-e063-6394a90a1cb2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Baclofen
Dosage form
TABLET
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA212067
Marketing category
ANDA
Marketing start
2024-05-23
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
80425-0391-1Baclofen30 in 1 BOTTLETABLET301
80425-0391-2Baclofen60 in 1 BOTTLETABLET601
80425-0391-3Baclofen90 in 1 BOTTLETABLET901
80425-0391-4Baclofen120 in 1 BOTTLETABLET1201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0391-1EA - Each80425-0391fe476b6e-e8dd-4dc2-be79-e9851d68601a12024-07-12
80425-0391-2EA - Each80425-0391be54ded2-d518-45cd-b714-095f71b8f93112024-07-12
80425-0391-3EA - Each80425-0391fb1aa0bc-a7e7-4356-8c28-d427e344054f12024-07-12
80425-0391-4EA - Each80425-039190bcd57d-44a3-41a8-8510-72d5bcb7a3e412024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0391BACLOFEN TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]1Current NDC, 4 package rows20240601_19b049cf-56a4-aeaa-e063-6394a90a366d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197391baclofen 10 MG Oral TabletPSN19b049cf-56a4-aeaa-e063-6394a90a366d1
197391baclofen 10 MG Oral TabletSCD19b049cf-56a4-aeaa-e063-6394a90a366d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0391-18042503910130 TABLET in 1 BOTTLE (80425-0391-1) 30 tablet2024-05-23NoNoHistorical
80425-0391-28042503910260 TABLET in 1 BOTTLE (80425-0391-2) 60 tablet2024-05-23NoNoHistorical
80425-0391-38042503910390 TABLET in 1 BOTTLE (80425-0391-3) 90 tablet2024-05-23NoNoHistorical
80425-0391-480425039104120 TABLET in 1 BOTTLE (80425-0391-4) 120 tablet2024-05-23NoNoHistorical