FDA.reportPublic FDA data

BACLOFEN

Product NDC
82804-242
11-digit product format
828040242
Labeler code
82804
Product ID
82804-242_417434af-df40-42f0-9a34-9127ddafd503
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BACLOFEN
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA209102
Marketing category
ANDA
Marketing start
2018-04-01
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
BACLOFEN
Listing expiration
2027-12-31

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
82804-242-20BACLOFEN20 in 1 BOTTLETABLET205
82804-242-30BACLOFEN30 in 1 BOTTLETABLET305
82804-242-60BACLOFEN60 in 1 BOTTLETABLET605
82804-242-72BACLOFEN120 in 1 BOTTLETABLET1205
82804-242-78BACLOFEN180 in 1 BOTTLETABLET1805
82804-242-90BACLOFEN90 in 1 BOTTLETABLET905

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197391baclofen 10 MG Oral TabletPSN0680301a-1649-46c4-b74e-ab03967945d05
197391baclofen 10 MG Oral TabletSCD0680301a-1649-46c4-b74e-ab03967945d05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82804-242-208280402422020 TABLET in 1 BOTTLE (82804-242-20) 20 tablet2025-12-29NoNoCurrent
82804-242-308280402423030 TABLET in 1 BOTTLE (82804-242-30) 30 tablet2025-11-07NoNoCurrent
82804-242-608280402426060 TABLET in 1 BOTTLE (82804-242-60) 60 tablet2025-10-28NoNoCurrent
82804-242-7282804024272120 TABLET in 1 BOTTLE (82804-242-72) 120 tablet2025-10-09NoNoCurrent
82804-242-7882804024278180 TABLET in 1 BOTTLE (82804-242-78) 180 tablet2025-10-28NoNoCurrent
82804-242-908280402429090 TABLET in 1 BOTTLE (82804-242-90) 90 tablet2025-09-05NoNoCurrent