FDA.reportPublic FDA data

Baclofen

Product NDC
68788-9246
Requested package NDC
68788-9246-3
11-digit product format
687889246
Labeler code
68788
Product ID
68788-9246_b605ca0d-58f9-4995-b87e-e5b186fa9ce7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
baclofen
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA078220
Marketing category
ANDA
Marketing start
2014-10-22
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
2027-12-31
Current FDA listing
Yes

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.

Additional Listing Data#

Finished product
Yes
Brand name base
Baclofen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACLOFEN10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
H789N3FKE8Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197391Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
58416ceb-994f-4571-afbd-c2171823f528Available on FDA.report

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
68788-9246-1Baclofen100 in 1 BOTTLE, PLASTICTABLET10010
68788-9246-3Baclofen30 in 1 BOTTLE, PLASTICTABLET3010
68788-9246-6Baclofen60 in 1 BOTTLE, PLASTICTABLET6010
68788-9246-8Baclofen120 in 1 BOTTLE, PLASTICTABLET12010
68788-9246-9Baclofen90 in 1 BOTTLE, PLASTICTABLET9010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-9246-1EA - Each68788-9246150c5272-1bc0-4f45-bfe3-d2e3ea22192f12021-12-08
68788-9246-3EA - Each68788-924678f5697b-82bf-43be-950f-c312ea38dcf312021-12-08
68788-9246-6EA - Each68788-92468eaf70b9-ee0e-484e-8f85-82b2cbce252f12021-12-08
68788-9246-8EA - Each68788-924622f97b72-b286-4ea2-bf23-7a9b1ca516a712021-12-08
68788-9246-9EA - Each68788-9246f0a08cd4-b1c1-4829-b9c7-3deccccb78de12021-12-08

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-9246BACLOFEN TABLET [PREFERRED PHARMACEUTICALS, INC.]9Current NDC, Legacy NDC, 5 package rows20240306_58416ceb-994f-4571-afbd-c2171823f528.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
ndc (package): 68788-9246-3
ndc (product): 68788-9246
ndc11 (package): 68788924603
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 TabletPSN58416ceb-994f-4571-afbd-c2171823f52810
197391baclofen 10 MG Oral TabletSCD58416ceb-994f-4571-afbd-c2171823f52810

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-9246-36878892460330 TABLET in 1 BOTTLE, PLASTIC (68788-9246-3) 30 tablet2014-10-220000-00-00NoNoCurrent