FDA.reportPublic FDA data

Baclofen

Product NDC
42254-061
11-digit product format
422540061
Labeler code
42254
Product ID
42254-061_c4ca2b1a-fdb8-4131-8b80-8784e79c1ce5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Baclofen
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
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
42254-061-302019-09-24C16284748780-19350213a-3d76-c013-e053-90daa90a1393BACLOFEN TABLETS USP
42254-061-602019-09-24C16284748780-19350213a-3d76-c013-e053-90daa90a1393BACLOFEN TABLETS USP
42254-061-902019-09-24C16284748780-19350213a-3d76-c013-e053-90daa90a1393BACLOFEN TABLETS USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42254-061-30Baclofen30 in 1 BOTTLETABLET301
42254-061-60Baclofen60 in 1 BOTTLETABLET601
42254-061-90Baclofen90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42254-061-30EA - Each42254-061a7c65912-ee60-467a-8fee-1434e8bdfa7e12012-07-24
42254-061-60EA - Each42254-0618b3c1c9a-1f0a-4a4b-8ee9-fdb3e2ba57fd12012-07-24
42254-061-90EA - Each42254-061391c183f-8b77-431b-93da-5e88da16d0cb12012-07-24

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42254-061BACLOFEN TABLET [REBEL DISTRIBUTORS CORP]1Legacy NDC, 3 package rows20120420_c4ca2b1a-fdb8-4131-8b80-8784e79c1ce5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197391baclofen 10 MG Oral TabletPSNc4ca2b1a-fdb8-4131-8b80-8784e79c1ce51
197392baclofen 20 MG Oral TabletPSNc4ca2b1a-fdb8-4131-8b80-8784e79c1ce51
197391baclofen 10 MG Oral TabletSCDc4ca2b1a-fdb8-4131-8b80-8784e79c1ce51
197392baclofen 20 MG Oral TabletSCDc4ca2b1a-fdb8-4131-8b80-8784e79c1ce51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
42254-061-304225400613030 in 1 BOTTLEHistorical
42254-061-604225400616060 in 1 BOTTLEHistorical
42254-061-904225400619090 in 1 BOTTLEHistorical