FDA.reportPublic FDA data

Baclofen

Product NDC
58657-731
11-digit product format
586570731
Labeler code
58657
Product ID
58657-731_3aa113f3-27d5-328b-e063-6394a90af9e5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Baclofen
Dosage form
TABLET
Route
ORAL
Labeler
Method Pharmaceuticals LLC
Application
ANDA212378
Marketing category
ANDA
Marketing start
2024-06-15
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, 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
58657-731-01Baclofen100 in 1 BOTTLETABLET1002
58657-731-10Baclofen1000 in 1 BOTTLETABLET10002
58657-731-50Baclofen500 in 1 BOTTLETABLET5002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58657-731-01EA - Each58657-7312d602012-3e89-44bb-b5cb-5ff8ffb6c21a12024-08-12
58657-731-10EA - Each58657-7315112e922-d8cb-49d4-8f76-30a456fcca6912024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58657-731BACLOFEN TABLET [METHOD PHARMACEUTICALS LLC]1Current NDC, 3 package rows20240617_1a9db542-d2b0-141a-e063-6394a90acc11.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197391baclofen 10 MG Oral TabletPSN08a6866f-b127-482f-9f22-113175487bdd101
197391baclofen 10 MG Oral TabletPSN8a39dbc7-99d7-49e4-b5a1-cf70e7d753b2101
197391baclofen 10 MG Oral TabletSCD08a6866f-b127-482f-9f22-113175487bdd101
197391baclofen 10 MG Oral TabletSCD8a39dbc7-99d7-49e4-b5a1-cf70e7d753b2101
197391baclofen 10 MG Oral TabletPSN1a9db542-d2b0-141a-e063-6394a90acc112
197392baclofen 20 MG Oral TabletPSN1a9db542-d2b0-141a-e063-6394a90acc112
430902baclofen 5 MG Oral TabletPSN1a9db542-d2b0-141a-e063-6394a90acc112
197391baclofen 10 MG Oral TabletSCD1a9db542-d2b0-141a-e063-6394a90acc112
197392baclofen 20 MG Oral TabletSCD1a9db542-d2b0-141a-e063-6394a90acc112
430902baclofen 5 MG Oral TabletSCD1a9db542-d2b0-141a-e063-6394a90acc112
197391baclofen 10 MG Oral TabletPSN0a5940cd-63eb-4d1b-8e92-44df264bc05a1
197391baclofen 10 MG Oral TabletSCD0a5940cd-63eb-4d1b-8e92-44df264bc05a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58657-731-0158657073101100 TABLET in 1 BOTTLE (58657-731-01) 100 tablet2024-06-15NoNoCurrent
58657-731-10586570731101000 TABLET in 1 BOTTLE (58657-731-10) 1000 tablet2024-06-15NoNoCurrent
58657-731-5058657073150500 TABLET in 1 BOTTLE (58657-731-50) 500 tablet2024-06-15NoNoCurrent