FDA.reportPublic FDA data

Baclofen

Product NDC
0904-6475
11-digit product format
009046475
Labeler code
0904
Product ID
0904-6475_9b1e8651-0d74-4a7a-a35f-480c94a4ecc0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
baclofen
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA078220
Marketing category
ANDA
Marketing start
2015-07-15
Marketing end
2027-05-31
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Baclofen

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
0904-6475-61Baclofen1 in 1 BLISTER PACKTABLET111
0904-6475-61Baclofen100 in 1 CARTONTABLET10011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6475-61EA - Each0904-64750c707e87-7642-48a9-91c8-626c07d9346512015-08-04

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6475BACLOFEN TABLET [MAJOR PHARMACEUTICALS]8Current NDC, Legacy NDC, 2 package rows20250210_ae732bdc-5178-4565-8219-d1787a5211a6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197391baclofen 10 MG Oral TabletPSN2278954a-7605-426a-ae85-1bf0a311742011
197391baclofen 10 MG Oral TabletPSNae732bdc-5178-4565-8219-d1787a5211a611
197392baclofen 20 MG Oral TabletPSN2278954a-7605-426a-ae85-1bf0a311742011
197392baclofen 20 MG Oral TabletPSNae732bdc-5178-4565-8219-d1787a5211a611
197391baclofen 10 MG Oral TabletSCD2278954a-7605-426a-ae85-1bf0a311742011
197391baclofen 10 MG Oral TabletSCDae732bdc-5178-4565-8219-d1787a5211a611
197392baclofen 20 MG Oral TabletSCD2278954a-7605-426a-ae85-1bf0a311742011
197392baclofen 20 MG Oral TabletSCDae732bdc-5178-4565-8219-d1787a5211a611

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6475-6100904647561100 BLISTER PACK in 1 CARTON (0904-6475-61) / 1 TABLET in 1 BLISTER PACK100 blister pack2015-07-152027-05-31NoNoCurrent