FDA.reportPublic FDA data

Baclofen

Product NDC
43063-864
11-digit product format
430630864
Labeler code
43063
Product ID
43063-864_415c3642-f324-746e-e063-6294a90a7ae0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
baclofen
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA078220
Marketing category
ANDA
Marketing start
2007-07-01
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
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, 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
43063-864-30Baclofen30 in 1 BOTTLE, PLASTICTABLET3026
43063-864-60Baclofen60 in 1 BOTTLE, PLASTICTABLET6026
43063-864-90Baclofen90 in 1 BOTTLE, PLASTICTABLET9026

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-864BACLOFEN TABLET [PD-RX PHARMACEUTICALS, INC.]25Current NDC, Legacy NDC, 3 package rows20241017_cfcf519f-5d15-431d-89c8-961a0c38ba60.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197391baclofen 10 MG Oral TabletPSNcfcf519f-5d15-431d-89c8-961a0c38ba6026
197392baclofen 20 MG Oral TabletPSNcfcf519f-5d15-431d-89c8-961a0c38ba6026
197391baclofen 10 MG Oral TabletSCDcfcf519f-5d15-431d-89c8-961a0c38ba6026
197392baclofen 20 MG Oral TabletSCDcfcf519f-5d15-431d-89c8-961a0c38ba6026

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-864-304306308643030 TABLET in 1 BOTTLE, PLASTIC (43063-864-30) 30 tablet2018-06-260000-00-00NoNoCurrent
43063-864-604306308646060 TABLET in 1 BOTTLE, PLASTIC (43063-864-60) 60 tablet2018-06-260000-00-00NoNoCurrent
43063-864-904306308649090 TABLET in 1 BOTTLE, PLASTIC (43063-864-90) 90 tablet2018-06-260000-00-00NoNoCurrent