FDA.reportPublic FDA data

BACLOFEN

Product NDC
61919-093
Requested package NDC
61919-093-90
11-digit product format
619190093
Labeler code
61919
Product ID
61919-093_e9e76e2b-7d09-8c57-e053-2a95a90a8b3f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BACLOFEN
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA078220
Marketing category
ANDA
Marketing start
2019-07-29
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
2023-12-31
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 packagepackage61919-09361919-093-90IInactivated by FDA2026-10-05

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, Indexing SPL table
NDCEffectiveIndexing SPLRelated label
61919-093-072025-01-302cef2736-746a-d83d-e063-dadaa90ab31fBACLOFEN
61919-093-142025-01-302cef2736-746a-d83d-e063-dadaa90ab31fBACLOFEN
61919-093-302025-01-302cef2736-746a-d83d-e063-dadaa90ab31fBACLOFEN
61919-093-602025-01-309d75b9d0-d969-f424-e053-dadaa90a57ceBACLOFEN
61919-093-722025-01-302cef2736-746a-d83d-e063-dadaa90ab31fBACLOFEN
61919-093-862025-01-309d75b9d0-d969-f424-e053-dadaa90a57ceBACLOFEN
61919-093-902025-01-309d75b9d0-d969-f424-e053-dadaa90a57ceBACLOFEN
61919-093-302020-12-149d75b9d0-d969-f424-e053-dadaa90a57ceBACLOFEN
61919-093-862020-12-149d75b9d0-d969-f424-e053-dadaa90a57ceBACLOFEN
61919-093-302020-01-319d75b9d0-d969-f424-e053-dadaa90a57ceBACLOFEN
61919-093-862020-01-319d75b9d0-d969-f424-e053-dadaa90a57ceBACLOFEN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-093-07BACLOFEN7 in 1 BOTTLETABLET76
61919-093-14BACLOFEN14 in 1 BOTTLETABLET146
61919-093-30BACLOFEN30 in 1 BOTTLETABLET306
61919-093-60BACLOFEN60 in 1 BOTTLETABLET606
61919-093-72BACLOFEN120 in 1 BOTTLETABLET1206
61919-093-86BACLOFEN270 in 1 BOTTLETABLET2706
61919-093-90BACLOFEN90 in 1 BOTTLETABLET906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-093-07EA - Each61919-093df1c97db-877b-4dfe-a6f8-61ac4f3609be12023-04-07
61919-093-14EA - Each61919-09355d1986f-f9c6-4579-b0b3-85739c96207012023-04-07
61919-093-30EA - Each61919-0939156cb79-67f9-4c7a-bdd7-d29e5a64097312015-10-02
61919-093-60EA - Each61919-093db26dde6-b322-46d8-80aa-6e6ea35984e412015-10-02
61919-093-72EA - Each61919-0935ecae864-e904-46ec-85bc-79f33bb8583712019-08-06
61919-093-86EA - Each61919-093ed915d28-89d6-4531-87d0-db514bcdb99012019-09-05
61919-093-90EA - Each61919-093dca01666-46e7-41f8-ae3a-b0b2731be40712015-02-02

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-093BACLOFEN TABLET [DIRECT RX]6Legacy NDC, 3 package rows20221001_b6309f7f-e8ed-4233-b160-3838ff2bab13.zip
61919-093BACLOFEN TABLET [DIRECT_RX]6Legacy NDC, 4 package rows20230929_8ed7ca43-28e3-ef10-e053-2995a90af4a9.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 TabletPSN8ed7ca43-28e3-ef10-e053-2995a90af4a96
197391baclofen 10 MG Oral TabletPSNb6309f7f-e8ed-4233-b160-3838ff2bab136
197391baclofen 10 MG Oral TabletSCD8ed7ca43-28e3-ef10-e053-2995a90af4a96
197391baclofen 10 MG Oral TabletSCDb6309f7f-e8ed-4233-b160-3838ff2bab136

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-093-906191900939090 TABLET in 1 BOTTLE (61919-093-90) 90 tablet2014-01-010000-00-00NoNoCurrent