FDA.reportPublic FDA data

Baclofen

Product NDC
0832-1055
11-digit product format
008321055
Labeler code
0832
Product ID
0832-1055_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
2026-09-30
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Baclofen

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACLOFEN20 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
0832-1055-10Baclofen1000 in 1 BOTTLETABLET10008
0832-1055-11Baclofen100 in 1 BOTTLETABLET1008
0832-1055-15Baclofen500 in 1 BOTTLETABLET5008
0832-1055-90Baclofen90 in 1 BOTTLETABLET908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0832-1055-10EA - Each0832-10551b9fc72e-9af6-449e-9493-7d82db47256912018-03-08
0832-1055-11EA - Each0832-10550f604831-6cd1-4494-a3bd-33c01319ebcc12018-03-08
0832-1055-15EA - Each0832-1055e9ac7b5f-2d2e-49e1-9f6e-f4dd868e692612018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0832-1055BACLOFEN 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0832-1055-10008321055101000 TABLET in 1 BOTTLE (0832-1055-10) 1000 tablet2018-02-272026-09-30NoNoCurrent
0832-1055-1100832105511100 TABLET in 1 BOTTLE (0832-1055-11) 100 tablet2018-02-270000-00-00NoNoCurrent
0832-1055-1500832105515500 TABLET in 1 BOTTLE (0832-1055-15) 500 tablet2018-02-272026-09-30NoNoCurrent
0832-1055-900083210559090 TABLET in 1 BOTTLE (0832-1055-90) 90 tablet2018-02-272026-09-30NoNoCurrent