FDA.reportPublic FDA data

Baclofen

Product NDC
50436-9022
11-digit product format
504369022
Labeler code
50436
Product ID
50436-9022_09d2deae-1b90-4d32-8d8e-390a5e193d18
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Baclofen
Dosage form
TABLET
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA072234
Marketing category
ANDA
Marketing start
1988-07-21
Marketing end
0000-00-00
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
2022-12-31
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
50436-9022-12023-01-30C16284748780-19d75b9cf-fdc7-f424-e053-dadaa90a57ceBACLOFEN TABLETS USP 4096 4097 Rx only
50436-9022-22023-01-30C16284748780-19d75b9cf-fdc7-f424-e053-dadaa90a57ceBACLOFEN TABLETS USP 4096 4097 Rx only
50436-9022-32023-01-30C16284748780-19d75b9cf-fdc7-f424-e053-dadaa90a57ceBACLOFEN TABLETS USP 4096 4097 Rx only
50436-9022-52023-01-30C16284748780-19d75b9cf-fdc7-f424-e053-dadaa90a57ceBACLOFEN TABLETS USP 4096 4097 Rx only
50436-9022-12021-03-24C16284748780-19d75b9cf-fdc7-f424-e053-dadaa90a57ceBACLOFEN TABLETS USP 4096 4097 Rx only
50436-9022-22021-03-24C16284748780-19d75b9cf-fdc7-f424-e053-dadaa90a57ceBACLOFEN TABLETS USP 4096 4097 Rx only
50436-9022-32021-03-24C16284748780-19d75b9cf-fdc7-f424-e053-dadaa90a57ceBACLOFEN TABLETS USP 4096 4097 Rx only
50436-9022-52021-03-24C16284748780-19d75b9cf-fdc7-f424-e053-dadaa90a57ceBACLOFEN TABLETS USP 4096 4097 Rx only
50436-9022-12020-01-31C16284748780-19d75b9cf-fdc7-f424-e053-dadaa90a57ceBACLOFEN TABLETS USP 4096 4097 Rx only
50436-9022-22020-01-31C16284748780-19d75b9cf-fdc7-f424-e053-dadaa90a57ceBACLOFEN TABLETS USP 4096 4097 Rx only
50436-9022-32020-01-31C16284748780-19d75b9cf-fdc7-f424-e053-dadaa90a57ceBACLOFEN TABLETS USP 4096 4097 Rx only
50436-9022-52020-01-31C16284748780-19d75b9cf-fdc7-f424-e053-dadaa90a57ceBACLOFEN TABLETS USP 4096 4097 Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-9022-1Baclofen30 in 1 BOTTLETABLET306
50436-9022-2Baclofen60 in 1 BOTTLETABLET606
50436-9022-3Baclofen90 in 1 BOTTLETABLET906
50436-9022-5Baclofen120 in 1 BOTTLETABLET1206

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-9022-1EA - Each50436-9022b601187d-7cb5-4573-a3f1-19a0769a8dbf12013-04-01
50436-9022-2EA - Each50436-902212d1661d-052f-445a-af04-48dac0b0406312013-04-01
50436-9022-3EA - Each50436-9022ad40be83-c66b-47dc-ab20-bb1934a44c9912014-11-05
50436-9022-5EA - Each50436-9022a502707e-9929-40d1-8684-0673b11ef00212015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BACLOFENACTIVE INGREDIENTH789N3FKE8BACLOFEN TABLET [UNIT DOSE SERVICES]3
BACLOFENACTIVE MOIETYH789N3FKE8BACLOFEN TABLET [UNIT DOSE SERVICES]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKBACLOFEN TABLET [UNIT DOSE SERVICES]3
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPBACLOFEN TABLET [UNIT DOSE SERVICES]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBACLOFEN TABLET [UNIT DOSE SERVICES]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BACLOFEN TABLET [UNIT DOSE SERVICES]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BACLOFEN TABLET [UNIT DOSE SERVICES]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2BACLOFEN TABLET [UNIT DOSE SERVICES]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-9022BACLOFEN TABLET [UNIT DOSE SERVICES]6Legacy NDC, 4 package rows20210325_ec9c8b7f-9fb0-4274-9532-2fee335c055d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197391baclofen 10 MG Oral TabletPSNec9c8b7f-9fb0-4274-9532-2fee335c055d6
197391baclofen 10 MG Oral TabletSCDec9c8b7f-9fb0-4274-9532-2fee335c055d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50436-9022-15043690220130 TABLET in 1 BOTTLE (50436-9022-1) 30 tablet2021-03-240000-00-00NoNoCurrent
50436-9022-25043690220260 TABLET in 1 BOTTLE (50436-9022-2) 60 tablet2021-03-240000-00-00NoNoCurrent
50436-9022-35043690220390 TABLET in 1 BOTTLE (50436-9022-3) 90 tablet2021-03-240000-00-00NoNoCurrent
50436-9022-550436902205120 TABLET in 1 BOTTLE (50436-9022-5) 120 tablet2021-03-240000-00-00NoNoCurrent