Baclofen

Product NDC
66336-486
11-digit product format
663360486
Labeler code
66336
Product ID
66336-486_9b60cb0d-4259-49dc-8b29-0dcf504cf40f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Baclofen
Dosage form
TABLET
Route
ORAL
Labeler
Dispensing Solutions, Inc.
Application
ANDA077068
Marketing category
ANDA
Marketing start
2005-08-30
Marketing end
0000-00-00
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
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66336-486-942019-11-27C16284748780-19855d018-da4b-cd31-e053-dbdaa90ab51aBACLOFEN TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66336-486-94Baclofen120 in 1 BOTTLE, PLASTICTABLET1201

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BACLOFENACTIVE INGREDIENTH789N3FKE8BACLOFEN TABLET [DISPENSING SOLUTIONS, INC.]1
BACLOFENACTIVE MOIETYH789N3FKE8BACLOFEN TABLET [DISPENSING SOLUTIONS, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBACLOFEN TABLET [DISPENSING SOLUTIONS, INC.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKBACLOFEN TABLET [DISPENSING SOLUTIONS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BACLOFEN TABLET [DISPENSING SOLUTIONS, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BACLOFEN TABLET [DISPENSING SOLUTIONS, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBACLOFEN TABLET [DISPENSING SOLUTIONS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66336-486BACLOFEN TABLET [DISPENSING SOLUTIONS, INC.]1Legacy NDC, 1 package rows20130803_2a7e8eb1-6a38-47b1-bc2b-b59f709f8cda.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197391baclofen 10 MG Oral TabletPSN2a7e8eb1-6a38-47b1-bc2b-b59f709f8cda1
197392baclofen 20 MG Oral TabletPSN2a7e8eb1-6a38-47b1-bc2b-b59f709f8cda1
197391baclofen 10 MG Oral TabletSCD2a7e8eb1-6a38-47b1-bc2b-b59f709f8cda1
197392baclofen 20 MG Oral TabletSCD2a7e8eb1-6a38-47b1-bc2b-b59f709f8cda1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
66336-486-9466336048694120 in 1 BOTTLE, PLASTICHistorical