Baclofen

Product NDC
63739-480
11-digit product format
637390480
Labeler code
63739
Product ID
63739-480_b4ca1e70-fd8b-74a9-e053-2a95a90af1b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Baclofen
Dosage form
TABLET
Route
ORAL
Labeler
Mckesson Corporation DBA SKY Packaginng
Application
ANDA078401
Marketing category
ANDA
Marketing start
2011-01-01
Marketing end
0000-00-00
Substance
BACLOFEN
Active strength
20 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
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63739-480-102020-07-22C16284748780-1ab0e2407-336d-f274-e053-dbdaa90a6471d0644a68-d1bf-4fe0-92e6-b79037cf4d12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63739-480-10EA - Each63739-480a225831a-721b-4ac9-8849-c467f37d4e2312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BACLOFENACTIVE INGREDIENTH789N3FKE8BACLOFEN TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]4
BACLOFENACTIVE MOIETYH789N3FKE8BACLOFEN TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63739-480BACLOFEN TABLET [MCKESSON CORPORATION DBA SKY PACKAGINNG]19Legacy NDC20250426_d0644a68-d1bf-4fe0-92e6-b79037cf4d12.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63739-480-106373904801010 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-480-10) > 10 TABLET in 1 BLISTER PACK10 blister pack2016-05-040000-00-00NoNoCurrent