FDA.reportPublic FDA data

Baclofen

Product NDC
10135-532
11-digit product format
101350532
Labeler code
10135
Product ID
10135-532_3f668f68-659e-2740-e063-6394a90a6264
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
baclofen
Dosage form
TABLET
Route
ORAL
Labeler
Marlex Pharmaceuticals Inc
Application
ANDA077241
Marketing category
ANDA
Marketing start
2020-05-01
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Baclofen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACLOFEN10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiH789N3FKE8
Rxcui197391, 197392

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10135-532-01Baclofen100 in 1 BOTTLE, PLASTICTABLET1009
10135-532-05Baclofen500 in 1 BOTTLE, PLASTICTABLET5009
10135-532-10Baclofen1000 in 1 BOTTLE, PLASTICTABLET10009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-532-01EA - Each10135-53256474b6d-e369-48b9-9438-a41dcddb16fd12015-06-09
10135-532-10EA - Each10135-532d2186605-a0c2-4521-8b32-b234a24891b212015-06-09

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-532BACLOFEN TABLET [MARLEX PHARMACEUTICALS INC]8Current NDC, Legacy NDC, 3 package rows20241004_1b0f50c8-62e3-414d-96d3-5fd16e8043ab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197391baclofen 10 MG Oral TabletPSN1b0f50c8-62e3-414d-96d3-5fd16e8043ab9
197392baclofen 20 MG Oral TabletPSN1b0f50c8-62e3-414d-96d3-5fd16e8043ab9
197391baclofen 10 MG Oral TabletSCD1b0f50c8-62e3-414d-96d3-5fd16e8043ab9
197392baclofen 20 MG Oral TabletSCD1b0f50c8-62e3-414d-96d3-5fd16e8043ab9
197391baclofen 10 MG Oral TabletPSNd9e5a8b9-1524-41b4-942f-f95015dd17f91
197391baclofen 10 MG Oral TabletSCDd9e5a8b9-1524-41b4-942f-f95015dd17f91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10135-532-0110135053201100 TABLET in 1 BOTTLE, PLASTIC (10135-532-01) 100 tablet2020-05-010000-00-00NoNoCurrent
10135-532-0510135053205500 TABLET in 1 BOTTLE, PLASTIC (10135-532-05) 500 tablet2020-05-010000-00-00NoNoCurrent
10135-532-10101350532101000 TABLET in 1 BOTTLE, PLASTIC (10135-532-10) 1000 tablet2020-05-010000-00-00NoNoCurrent