FDA.reportPublic FDA data

Baclofen

Product NDC
82868-013
11-digit product format
828680013
Labeler code
82868
Product ID
82868-013_46dc934b-8b1e-a00e-e063-6394a90a5d4e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Baclofen
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA072234
Marketing category
ANDA
Marketing start
2023-09-27
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
82868-013-30Baclofen30 in 1 BOTTLE, PLASTICTABLET304
82868-013-60Baclofen60 in 1 BOTTLE, PLASTICTABLET604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82868-013BACLOFEN TABLET [NORTHWIND PHARMACEUTICALS, LLC]3Current NDC, 2 package rows20240110_06bcfb08-2ada-f803-e063-6394a90a826b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197391baclofen 10 MG Oral TabletPSN06bcfb08-2ada-f803-e063-6394a90a826b4
197391baclofen 10 MG Oral TabletSCD06bcfb08-2ada-f803-e063-6394a90a826b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82868-013-308286800133030 TABLET in 1 BOTTLE, PLASTIC (82868-013-30) 30 tablet2023-11-14NoNoHistorical
82868-013-608286800136060 TABLET in 1 BOTTLE, PLASTIC (82868-013-60) 60 tablet2023-09-27NoNoHistorical