FDA.reportPublic FDA data

Baclofen

Product NDC
63739-479
11-digit product format
637390479
Labeler code
63739
Product ID
63739-479_b4ca1e70-fd8b-74a9-e053-2a95a90af1b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Baclofen
Dosage form
TABLET
Route
ORAL
Labeler
Mckesson Corporation DBA SKY Packaginng
Application
ANDA078504
Marketing category
ANDA
Marketing start
2011-01-01
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
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63739-479DDiscontinued by firm2026-08-07
excluded packagepackage63739-47963739-479-10DDiscontinued by firm2026-08-07

Source provenance: Browse the complete Orange Book source catalog.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63739-479-102020-07-22C16284748780-1ab0e2407-336d-f274-e053-dbdaa90a6471Rx Only

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63739-479-10EA - Each63739-47993c12a59-8299-4c17-9a85-f074427e82b612012-07-24

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
63739-479BACLOFEN TABLET [MCKESSON CORPORATION DBA SKY PACKAGINNG]19Legacy NDC20250426_d0644a68-d1bf-4fe0-92e6-b79037cf4d12.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BaclofenBACLOFENProficient Rx LPb65d3089-0412-487f-a1b4-66f0bc6f398e2022-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078504
application number: ANDA078504

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63739-479-106373904791010 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-479-10) > 10 TABLET in 1 BLISTER PACK10 blister pack2016-05-040000-00-00NoNoCurrent