FDA.reportPublic FDA data

Baclofen

Product NDC
52959-733
11-digit product format
529590733
Labeler code
52959
Product ID
52959-733_0d3ec116-a621-4f15-bc56-c63487a319bc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Baclofen
Dosage form
TABLET
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA072234
Marketing category
ANDA
Marketing start
2010-07-15
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
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
52959-733-002019-11-13C16284748780-197449f38-b966-f6ea-e053-dbdaa90aa703BACLOFEN TABLETS USP
52959-733-022019-11-13C16284748780-197449f38-b966-f6ea-e053-dbdaa90aa703BACLOFEN TABLETS USP
52959-733-102019-11-13C16284748780-197449f38-b966-f6ea-e053-dbdaa90aa703BACLOFEN TABLETS USP
52959-733-122019-11-13C16284748780-197449f38-b966-f6ea-e053-dbdaa90aa703BACLOFEN TABLETS USP
52959-733-182019-11-13C16284748780-197449f38-b966-f6ea-e053-dbdaa90aa703BACLOFEN TABLETS USP
52959-733-202019-11-13C16284748780-197449f38-b966-f6ea-e053-dbdaa90aa703BACLOFEN TABLETS USP
52959-733-302019-11-13C16284748780-197449f38-b966-f6ea-e053-dbdaa90aa703BACLOFEN TABLETS USP
52959-733-402019-11-13C16284748780-197449f38-b966-f6ea-e053-dbdaa90aa703BACLOFEN TABLETS USP
52959-733-602019-11-13C16284748780-197449f38-b966-f6ea-e053-dbdaa90aa703BACLOFEN TABLETS USP
52959-733-902019-11-13C16284748780-197449f38-b966-f6ea-e053-dbdaa90aa703BACLOFEN TABLETS USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-733-00Baclofen100 in 1 BOTTLETABLET1002
52959-733-02Baclofen120 in 1 BOTTLETABLET1202
52959-733-10Baclofen10 in 1 BOTTLETABLET102
52959-733-12Baclofen12 in 1 BOTTLETABLET122
52959-733-18Baclofen18 in 1 BOTTLETABLET182
52959-733-20Baclofen20 in 1 BOTTLETABLET202
52959-733-30Baclofen30 in 1 BOTTLETABLET302
52959-733-40Baclofen40 in 1 BOTTLETABLET402
52959-733-60Baclofen60 in 1 BOTTLETABLET602
52959-733-90Baclofen90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-733-00EA - Each52959-733952a7b26-41d8-4869-abee-cdeccf6771a812012-07-24
52959-733-02EA - Each52959-733f9eb4f92-229c-4394-bedc-c1f7b7c66ac512012-07-24
52959-733-10EA - Each52959-733f37e8db0-8d03-412c-bf8d-63fac87d13e112012-07-24
52959-733-12EA - Each52959-733acf162c2-6669-4b51-9ec5-844286a0837a12012-07-24
52959-733-18EA - Each52959-7334497c7c7-de50-4aaa-b969-07f6ea10916712012-07-24
52959-733-20EA - Each52959-733de132a48-01bd-4ada-821d-d3e6dcace3a112012-07-24
52959-733-30EA - Each52959-733d1790f28-aa4c-46d0-8875-d3173be3826012012-07-24
52959-733-40EA - Each52959-733e0b56138-505e-4a5e-85df-6e0a90348ab012012-07-24
52959-733-60EA - Each52959-73350631257-6a9b-4a71-84d9-eb9c7f5ec9d112012-07-24
52959-733-90EA - Each52959-7334701f2e5-264b-42b7-ba1b-860bf8bd615312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BaclofenACTIVE INGREDIENTH789N3FKE8BACLOFEN TABLET [H.J. HARKINS COMPANY, INC.]2
BaclofenACTIVE MOIETYH789N3FKE8BACLOFEN TABLET [H.J. HARKINS COMPANY, INC.]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKBACLOFEN TABLET [H.J. HARKINS COMPANY, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBACLOFEN TABLET [H.J. HARKINS COMPANY, INC.]2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BACLOFEN TABLET [H.J. HARKINS COMPANY, INC.]2
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPBACLOFEN TABLET [H.J. HARKINS COMPANY, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BACLOFEN TABLET [H.J. HARKINS COMPANY, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2BACLOFEN TABLET [H.J. HARKINS COMPANY, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-733BACLOFEN TABLET [H.J. HARKINS COMPANY, INC.]2Legacy NDC, 10 package rows20111214_962601f8-7567-4afe-90a0-6df356f5a297.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197391baclofen 10 MG Oral TabletPSN962601f8-7567-4afe-90a0-6df356f5a2972
197392baclofen 20 MG Oral TabletPSN962601f8-7567-4afe-90a0-6df356f5a2972
197391baclofen 10 MG Oral TabletSCD962601f8-7567-4afe-90a0-6df356f5a2972
197392baclofen 20 MG Oral TabletSCD962601f8-7567-4afe-90a0-6df356f5a2972

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-733-0052959073300100 in 1 BOTTLEHistorical
52959-733-0252959073302120 in 1 BOTTLEHistorical
52959-733-105295907331010 in 1 BOTTLEHistorical
52959-733-125295907331212 in 1 BOTTLEHistorical
52959-733-185295907331818 in 1 BOTTLEHistorical
52959-733-205295907332020 in 1 BOTTLEHistorical
52959-733-305295907333030 in 1 BOTTLEHistorical
52959-733-405295907334040 in 1 BOTTLEHistorical
52959-733-605295907336060 in 1 BOTTLEHistorical
52959-733-905295907339090 in 1 BOTTLEHistorical