FDA.reportPublic FDA data

Baclofen

Product NDC
70518-4249
11-digit product format
705184249
Labeler code
70518
Product ID
70518-4249_4830dd4a-4315-ff2a-e063-6294a90a3efb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Baclofen
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA212067
Marketing category
ANDA
Marketing start
2024-12-30
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Baclofen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACLOFEN10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiH789N3FKE8
Rxcui197391

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
70518-4249-0Baclofen30 in 1 BLISTER PACKTABLET305
70518-4249-1Baclofen90 in 1 BOTTLE, PLASTICTABLET905
70518-4249-2Baclofen30 in 1 BLISTER PACKTABLET305
70518-4249-3Baclofen30 in 1 BOTTLE, PLASTICTABLET305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4249BACLOFEN TABLET [REMEDYREPACK INC.]1Current NDC, 4 package rows20250101_76896b07-2835-4467-b386-87ec66ddd88e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197391baclofen 10 MG Oral TabletPSN76896b07-2835-4467-b386-87ec66ddd88e5
197391baclofen 10 MG Oral TabletSCD76896b07-2835-4467-b386-87ec66ddd88e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4249-07051842490030 TABLET in 1 BLISTER PACK (70518-4249-0) 30 tablet2024-12-30NoNoCurrent
70518-4249-17051842490190 TABLET in 1 BOTTLE, PLASTIC (70518-4249-1) 90 tablet2025-08-01NoNoCurrent
70518-4249-27051842490230 TABLET in 1 BLISTER PACK (70518-4249-2) 30 tablet2025-08-09NoNoCurrent
70518-4249-37051842490330 TABLET in 1 BOTTLE, PLASTIC (70518-4249-3) 30 tablet2026-01-11NoNoCurrent