FDA.reportPublic FDA data

Baclofen

Product NDC
29300-344
11-digit product format
293000344
Labeler code
29300
Product ID
29300-344_513de439-4155-4a5d-a25c-bced499e293a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Baclofen
Dosage form
TABLET
Route
ORAL
Labeler
Unichem Pharmaceuticals (USA), Inc.
Application
ANDA212067
Marketing category
ANDA
Marketing start
2020-07-09
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
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
BACLOFEN20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiH789N3FKE8
Rxcui197391, 197392, 430902

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
29300-344-01Baclofen100 in 1 BOTTLETABLET1006
29300-344-05Baclofen500 in 1 BOTTLETABLET5006
29300-344-10Baclofen1000 in 1 BOTTLETABLET10006
29300-344-19Baclofen90 in 1 BOTTLETABLET906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29300-344BACLOFEN TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]6Current NDC, Legacy NDC, 4 package rows20230615_b9199878-3fb4-46dc-adbb-b3d9dc3852d4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197392baclofen 20 MG Oral TabletPSN8cb96e7b-9c40-46a9-b964-7a573b7a0342101
197392baclofen 20 MG Oral TabletSCD8cb96e7b-9c40-46a9-b964-7a573b7a0342101
197391baclofen 10 MG Oral TabletPSNb9199878-3fb4-46dc-adbb-b3d9dc3852d46
197392baclofen 20 MG Oral TabletPSNb9199878-3fb4-46dc-adbb-b3d9dc3852d46
430902baclofen 5 MG Oral TabletPSNb9199878-3fb4-46dc-adbb-b3d9dc3852d46
197391baclofen 10 MG Oral TabletSCDb9199878-3fb4-46dc-adbb-b3d9dc3852d46
197392baclofen 20 MG Oral TabletSCDb9199878-3fb4-46dc-adbb-b3d9dc3852d46
430902baclofen 5 MG Oral TabletSCDb9199878-3fb4-46dc-adbb-b3d9dc3852d46
197392baclofen 20 MG Oral TabletPSN29987a4c-cf5f-4f98-e063-6394a90a7f192
197392baclofen 20 MG Oral TabletSCD29987a4c-cf5f-4f98-e063-6394a90a7f192
197392baclofen 20 MG Oral TabletPSN45c6d45d-95d5-21b8-e063-6294a90a79551
197392baclofen 20 MG Oral TabletPSNab5fd609-3081-4400-90cd-c83b6834d3811
197392baclofen 20 MG Oral TabletSCD45c6d45d-95d5-21b8-e063-6294a90a79551
197392baclofen 20 MG Oral TabletSCDab5fd609-3081-4400-90cd-c83b6834d3811

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
29300-344-0129300034401100 TABLET in 1 BOTTLE (29300-344-01) 100 tablet2020-07-090000-00-00NoNoCurrent
29300-344-0529300034405500 TABLET in 1 BOTTLE (29300-344-05) 500 tablet2020-07-090000-00-00NoNoCurrent
29300-344-10293000344101000 TABLET in 1 BOTTLE (29300-344-10) 1000 tablet2020-07-090000-00-00NoNoCurrent
29300-344-192930003441990 TABLET in 1 BOTTLE (29300-344-19) 90 tablet2022-08-250000-00-00NoNoCurrent