FDA.reportPublic FDA data

Baclofen

Product NDC
50436-9023
11-digit product format
504369023
Labeler code
50436
Product ID
50436-9023_c92ec4eb-82c5-45ce-aacb-08c0e234098c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Baclofen
Dosage form
TABLET
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA072235
Marketing category
ANDA
Marketing start
1988-07-21
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
50436-9023-12020-01-31C16284748780-19d75b9cf-fdc4-f424-e053-dadaa90a57ceBACLOFEN TABLETS USP 4096 4097 Rx only
50436-9023-22020-01-31C16284748780-19d75b9cf-fdc4-f424-e053-dadaa90a57ceBACLOFEN TABLETS USP 4096 4097 Rx only
50436-9023-32020-01-31C16284748780-19d75b9cf-fdc4-f424-e053-dadaa90a57ceBACLOFEN TABLETS USP 4096 4097 Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-9023-1Baclofen30 in 1 BOTTLETABLET303
50436-9023-2Baclofen60 in 1 BOTTLETABLET603
50436-9023-3Baclofen90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-9023-1EA - Each50436-90232a2d841d-c07f-4813-bcea-64b0da6b418f12016-05-16
50436-9023-2EA - Each50436-90234030ba22-e545-4939-a09b-980d2e54b8c312013-04-01
50436-9023-3EA - Each50436-9023f548862b-0e53-47cd-8f3f-3be336fd14fe12013-04-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BaclofenACTIVE INGREDIENTH789N3FKE8BACLOFEN TABLET [UNIT DOSE SERVICES]1
BaclofenACTIVE MOIETYH789N3FKE8BACLOFEN TABLET [UNIT DOSE SERVICES]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKBACLOFEN TABLET [UNIT DOSE SERVICES]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBACLOFEN TABLET [UNIT DOSE SERVICES]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BACLOFEN TABLET [UNIT DOSE SERVICES]1
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPBACLOFEN TABLET [UNIT DOSE SERVICES]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BACLOFEN TABLET [UNIT DOSE SERVICES]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2BACLOFEN TABLET [UNIT DOSE SERVICES]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-9023BACLOFEN TABLET [UNIT DOSE SERVICES]3Legacy NDC, 3 package rows20170316_a5bd706c-56ab-456e-92d0-3edd7800b783.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197392baclofen 20 MG Oral TabletPSNa5bd706c-56ab-456e-92d0-3edd7800b7833
197392baclofen 20 MG Oral TabletSCDa5bd706c-56ab-456e-92d0-3edd7800b7833

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-9023-15043690230130 in 1 BOTTLEHistorical
50436-9023-25043690230260 in 1 BOTTLEHistorical
50436-9023-35043690230390 in 1 BOTTLEHistorical