FDA.reportPublic FDA data

Baclofen

Product NDC
0832-1054
11-digit product format
008321054
Labeler code
0832
Product ID
0832-1054_45af8926-ad18-a93a-e063-6294a90a1dca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Baclofen
Dosage form
TABLET
Route
ORAL
Labeler
Upsher-Smith Laboratories, LLC
Application
ANDA074584
Marketing category
ANDA
Marketing start
2010-10-20
Marketing end
2026-10-31
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Baclofen

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACLOFEN10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiH789N3FKE8
Rxcui197391, 197392

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
0832-1054-10Baclofen1000 in 1 BOTTLETABLET10008
0832-1054-11Baclofen100 in 1 BOTTLETABLET1008
0832-1054-15Baclofen500 in 1 BOTTLETABLET5008
0832-1054-90Baclofen90 in 1 BOTTLETABLET908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0832-1054-10EA - Each0832-105474da9a49-4315-4383-97f9-3bc61f287d9012018-03-08
0832-1054-11EA - Each0832-105478815c52-0d03-4693-b9af-3bcf5413c7df12018-03-08
0832-1054-15EA - Each0832-105415ee48a0-e805-451d-883f-7d29adc5ac6712018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0832-1054BACLOFEN TABLET [UPSHER-SMITH LABORATORIES, LLC]6Current NDC, Legacy NDC, 4 package rows20230408_b2747a9d-5fca-4657-9e4b-4112607f30d8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197391baclofen 10 MG Oral TabletPSNb2747a9d-5fca-4657-9e4b-4112607f30d88
197392baclofen 20 MG Oral TabletPSNb2747a9d-5fca-4657-9e4b-4112607f30d88
197391baclofen 10 MG Oral TabletSCDb2747a9d-5fca-4657-9e4b-4112607f30d88
197392baclofen 20 MG Oral TabletSCDb2747a9d-5fca-4657-9e4b-4112607f30d88
197391baclofen 10 MG Oral TabletPSN081d478a-2f3f-456e-bcca-00487589da6f1
197391baclofen 10 MG Oral TabletPSNe163e7dc-45a5-43c2-b13d-a4453f2c360c1
197391baclofen 10 MG Oral TabletSCD081d478a-2f3f-456e-bcca-00487589da6f1
197391baclofen 10 MG Oral TabletSCDe163e7dc-45a5-43c2-b13d-a4453f2c360c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0832-1054-10008321054101000 TABLET in 1 BOTTLE (0832-1054-10) 1000 tablet2018-02-272026-10-31NoNoCurrent
0832-1054-1100832105411100 TABLET in 1 BOTTLE (0832-1054-11) 100 tablet2018-02-272026-10-31NoNoCurrent
0832-1054-1500832105415500 TABLET in 1 BOTTLE (0832-1054-15) 500 tablet2018-02-272026-10-31NoNoCurrent
0832-1054-900083210549090 TABLET in 1 BOTTLE (0832-1054-90) 90 tablet2018-02-272026-10-31NoNoCurrent