FDA.reportPublic FDA data

Baclofen

Product NDC
33261-011
11-digit product format
332610011
Labeler code
33261
Product ID
33261-011_c3489764-d9f9-4d2a-ab7f-3c3bfa652af7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Baclofen
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
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
No
Listing certified through
2019-12-31
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
33261-011-302020-01-31C16284748780-19d75b9d0-49c0-f424-e053-dadaa90a57ceBACLOFEN TABLETS, USP
33261-011-602020-01-31C16284748780-19d75b9d0-49c0-f424-e053-dadaa90a57ceBACLOFEN TABLETS, USP
33261-011-902020-01-31C16284748780-19d75b9d0-49c0-f424-e053-dadaa90a57ceBACLOFEN TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-011-30Baclofen30 in 1 BOTTLE, PLASTICTABLET301
33261-011-60Baclofen60 in 1 BOTTLE, PLASTICTABLET601
33261-011-90Baclofen90 in 1 BOTTLE, PLASTICTABLET901

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-011BACLOFEN TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 3 package rows20140102_b127bc0c-6e3b-4906-ab5f-6992a9775038.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197391baclofen 10 MG Oral TabletPSNb127bc0c-6e3b-4906-ab5f-6992a97750381
197392baclofen 20 MG Oral TabletPSNb127bc0c-6e3b-4906-ab5f-6992a97750381
197391baclofen 10 MG Oral TabletSCDb127bc0c-6e3b-4906-ab5f-6992a97750381
197392baclofen 20 MG Oral TabletSCDb127bc0c-6e3b-4906-ab5f-6992a97750381

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-011-303326100113030 in 1 BOTTLE, PLASTICHistorical
33261-011-603326100116060 in 1 BOTTLE, PLASTICHistorical
33261-011-903326100119090 in 1 BOTTLE, PLASTICHistorical