FDA.reportPublic FDA data

Baclofen

Product NDC
63187-147
11-digit product format
631870147
Labeler code
63187
Product ID
63187-147_545b5e31-4716-4343-994b-5428ae82be8a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Baclofen
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA072234
Marketing category
ANDA
Marketing start
1988-07-21
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

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
63187-147-20Baclofen20 in 1 BOTTLETABLET207
63187-147-30Baclofen30 in 1 BOTTLETABLET307
63187-147-60Baclofen60 in 1 BOTTLETABLET607
63187-147-78Baclofen180 in 1 BOTTLETABLET1807
63187-147-90Baclofen90 in 1 BOTTLETABLET907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-147-20EA - Each63187-147a056849f-d751-48df-b95c-532fd3c3fc6d12023-12-05
63187-147-30EA - Each63187-147d7314713-f888-41fd-954c-938da2d4665912016-09-02
63187-147-60EA - Each63187-147795fd955-86b3-44c8-bcbe-2fa466cca8c012016-09-02
63187-147-78EA - Each63187-14765fcc3cf-4841-45e9-a687-4fdf69053ddb12016-09-02
63187-147-90EA - Each63187-14711da93d4-0dd1-49a0-9bb7-e7304de02cb412016-09-02

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-147BACLOFEN TABLET [PROFICIENT RX LP]7Current NDC, Legacy NDC, 5 package rows20241024_b981eb16-a195-41da-a186-3e91b63b2def.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197391baclofen 10 MG Oral TabletPSNb981eb16-a195-41da-a186-3e91b63b2def7
197391baclofen 10 MG Oral TabletSCDb981eb16-a195-41da-a186-3e91b63b2def7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-147-206318701472020 TABLET in 1 BOTTLE (63187-147-20) 20 tablet2023-11-03NoNoCurrent
63187-147-306318701473030 TABLET in 1 BOTTLE (63187-147-30) 30 tablet2014-08-010000-00-00NoNoCurrent
63187-147-606318701476060 TABLET in 1 BOTTLE (63187-147-60) 60 tablet2014-08-010000-00-00NoNoCurrent
63187-147-7863187014778180 TABLET in 1 BOTTLE (63187-147-78) 180 tablet2014-08-010000-00-00NoNoCurrent
63187-147-906318701479090 TABLET in 1 BOTTLE (63187-147-90) 90 tablet2014-08-010000-00-00NoNoCurrent