FDA.reportPublic FDA data

Baclofen

Product NDC
45865-452
Requested package NDC
45865-452-30
11-digit product format
458650452
Labeler code
45865
Product ID
45865-452_71cad25b-9c6d-6797-e053-2a95a90a7b19
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
baclofen
Dosage form
TABLET
Route
ORAL
Labeler
Medsource Pharmaceuticals
Application
ANDA078220
Marketing category
ANDA
Marketing start
2007-07-01
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
2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage45865-45245865-452-30IInactivated by FDA2026-10-15

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Source provenance: Browse the complete Orange Book source catalog.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
45865-452-302025-01-30C16284748780-12cef2736-a43d-d83d-e063-dadaa90ab31fBACLOFEN TABLETS, USP
45865-452-602025-01-30C16284748780-12cef2736-a43d-d83d-e063-dadaa90ab31fBACLOFEN TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-452-30Baclofen30 in 1 BOTTLE, PLASTICTABLET301
45865-452-60Baclofen60 in 1 BOTTLE, PLASTICTABLET601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-452BACLOFEN TABLET [MEDSOURCE PHARMACEUTICALS]1Legacy NDC, 2 package rows20180725_71cad25b-9c6c-6797-e053-2a95a90a7b19.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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BaclofenBACLOFENCardinal Health 107, LLC2278954a-7605-426a-ae85-1bf0a31174202026-04-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078220
application number: ANDA078220
BaclofenBACLOFENPreferred Pharmaceuticals, Inc.58416ceb-994f-4571-afbd-c2171823f5282026-01-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078220
application number: ANDA078220
BaclofenBACLOFENMajor Pharmaceuticalsae732bdc-5178-4565-8219-d1787a5211a62026-01-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078220
application number: ANDA078220
BaclofenBACLOFENPD-Rx Pharmaceuticals, Inc.cfcf519f-5d15-431d-89c8-961a0c38ba602025-10-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078220
application number: ANDA078220
BaclofenBACLOFENBryant Ranch Prepackfc4b99b3-f59f-4e1f-9a8c-123a0c2fbd9f2024-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078220
application number: ANDA078220
BaclofenBACLOFENBryant Ranch Prepack402a0a2b-95a6-4d22-bedf-826e1f1cd2c32024-01-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078220
application number: ANDA078220
BaclofenBACLOFENBryant Ranch Prepack54bea140-c537-44a2-8d1d-bfb20471f4d82024-01-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078220
application number: ANDA078220
BaclofenBACLOFENBryant Ranch Prepack12d57610-8c70-4729-b358-56525613a29d2024-01-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078220
application number: ANDA078220
BaclofenBACLOFENBryant Ranch Prepackfded79a4-c354-448d-96dd-6dc69c46a0132023-10-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078220
application number: ANDA078220
BaclofenBACLOFENLannett Company, Inc.f84f3f4c-17e6-43f1-9600-63b0b175837b2021-02-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078220
application number: ANDA078220
BaclofenBACLOFENAphena Pharma Solutions - Tennessee, LLCd9e5a8b9-1524-41b4-942f-f95015dd17f92020-08-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078220
application number: ANDA078220

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197391baclofen 10 MG Oral TabletPSN71cad25b-9c6c-6797-e053-2a95a90a7b191
197391baclofen 10 MG Oral TabletSCD71cad25b-9c6c-6797-e053-2a95a90a7b191

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45865-452-304586504523030 TABLET in 1 BOTTLE, PLASTIC (45865-452-30) 30 tablet2018-01-010000-00-00NoNoCurrent