FDA.reportPublic FDA data

BACLOFEN

Product NDC
76420-242
11-digit product format
764200242
Labeler code
76420
Product ID
76420-242_2bbe83e4-da09-81e7-e063-6394a90a1f8e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BACLOFEN
Dosage form
TABLET
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA214099
Marketing category
ANDA
Marketing start
2021-07-13
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

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
76420-242-12BACLOFEN120 in 1 BOTTLETABLET1202
76420-242-30BACLOFEN30 in 1 BOTTLETABLET302
76420-242-60BACLOFEN60 in 1 BOTTLETABLET602
76420-242-90BACLOFEN90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-242-30EA - Each76420-2421de424f4-8a69-4514-9248-b1a6065ca98612022-09-12
76420-242-60EA - Each76420-24243c87d6f-96db-4237-a5ec-03c227b2351612022-09-12
76420-242-90EA - Each76420-242640f8a15-226d-4acc-bec6-46ea0963e30612022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-242BACLOFEN (BACLOFEN) TABLET [ASCLEMED USA, INC.]2Current NDC, Legacy NDC, 4 package rows20250116_687f48da-bc41-4700-9513-77a32fc86c93.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197391baclofen 10 MG Oral TabletPSN687f48da-bc41-4700-9513-77a32fc86c932
197392baclofen 20 MG Oral TabletPSN687f48da-bc41-4700-9513-77a32fc86c932
197391baclofen 10 MG Oral TabletSCD687f48da-bc41-4700-9513-77a32fc86c932
197392baclofen 20 MG Oral TabletSCD687f48da-bc41-4700-9513-77a32fc86c932

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76420-242-1276420024212120 TABLET in 1 BOTTLE (76420-242-12) 120 tablet2025-01-15NoNoHistorical
76420-242-307642002423030 TABLET in 1 BOTTLE (76420-242-30) 30 tablet2022-07-250000-00-00NoNoCurrent
76420-242-607642002426060 TABLET in 1 BOTTLE (76420-242-60) 60 tablet2022-07-250000-00-00NoNoCurrent
76420-242-907642002429090 TABLET in 1 BOTTLE (76420-242-90) 90 tablet2022-07-250000-00-00NoNoCurrent