FDA.reportPublic FDA data

BACLOFEN

Product NDC
76420-359
11-digit product format
764200359
Labeler code
76420
Product ID
76420-359_3c3b62bc-64f9-f0cb-e063-6394a90a4a92
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BACLOFEN
Dosage form
TABLET
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA209102
Marketing category
ANDA
Marketing start
2018-04-01
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, 2679605

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
76420-359-00BACLOFEN1000 in 1 BOTTLETABLET10002
76420-359-01BACLOFEN100 in 1 BOTTLETABLET1002
76420-359-05BACLOFEN500 in 1 BOTTLETABLET5002
76420-359-30BACLOFEN30 in 1 BOTTLETABLET302
76420-359-60BACLOFEN60 in 1 BOTTLETABLET602
76420-359-90BACLOFEN90 in 1 BOTTLETABLET902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-359BACLOFEN TABLET [ASCLEMED USA, INC.]1Current NDC, 6 package rows20250524_35bccefe-8d2e-85b5-e063-6394a90a58ca.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197391baclofen 10 MG Oral TabletPSN35bccefe-8d2e-85b5-e063-6394a90a58ca2
2679605baclofen 15 MG Oral TabletPSN35bccefe-8d2e-85b5-e063-6394a90a58ca2
197392baclofen 20 MG Oral TabletPSN35bccefe-8d2e-85b5-e063-6394a90a58ca2
430902baclofen 5 MG Oral TabletPSN35bccefe-8d2e-85b5-e063-6394a90a58ca2
197391baclofen 10 MG Oral TabletSCD35bccefe-8d2e-85b5-e063-6394a90a58ca2
2679605baclofen 15 MG Oral TabletSCD35bccefe-8d2e-85b5-e063-6394a90a58ca2
197392baclofen 20 MG Oral TabletSCD35bccefe-8d2e-85b5-e063-6394a90a58ca2
430902baclofen 5 MG Oral TabletSCD35bccefe-8d2e-85b5-e063-6394a90a58ca2
2679605baclofen 15 MG Oral TabletSY35bccefe-8d2e-85b5-e063-6394a90a58ca2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76420-359-00764200359001000 TABLET in 1 BOTTLE (76420-359-00) 1000 tablet2025-05-22NoNoHistorical
76420-359-0176420035901100 TABLET in 1 BOTTLE (76420-359-01) 100 tablet2025-05-22NoNoHistorical
76420-359-0576420035905500 TABLET in 1 BOTTLE (76420-359-05) 500 tablet2025-05-22NoNoHistorical
76420-359-307642003593030 TABLET in 1 BOTTLE (76420-359-30) 30 tablet2025-05-22NoNoHistorical
76420-359-607642003596060 TABLET in 1 BOTTLE (76420-359-60) 60 tablet2025-05-22NoNoHistorical
76420-359-907642003599090 TABLET in 1 BOTTLE (76420-359-90) 90 tablet2025-05-22NoNoHistorical