FDA.reportPublic FDA data

Baclofen

Product NDC
0904-6475
11-digit product format
009046475
Labeler code
0904
Product ID
0904-6475_9b1e8651-0d74-4a7a-a35f-480c94a4ecc0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
baclofen
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA078220
Marketing category
ANDA
Marketing start
2015-07-15
Marketing end
2027-05-31
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
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog.

Additional Listing Data#

Finished product
Yes
Brand name base
Baclofen

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197391Internal RxNorm lookup
197392Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ae732bdc-5178-4565-8219-d1787a5211a6Available 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
0904-6475-61Baclofen1 in 1 BLISTER PACKTABLET111
0904-6475-61Baclofen100 in 1 CARTONTABLET10011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6475-61EA - Each0904-64750c707e87-7642-48a9-91c8-626c07d9346512015-08-04

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6475BACLOFEN TABLET [MAJOR PHARMACEUTICALS]8Current NDC, Legacy NDC, 2 package rows20250210_ae732bdc-5178-4565-8219-d1787a5211a6.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
ndc (product): 0904-6475
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 TabletPSN2278954a-7605-426a-ae85-1bf0a311742011
197391baclofen 10 MG Oral TabletPSNae732bdc-5178-4565-8219-d1787a5211a611
197392baclofen 20 MG Oral TabletPSN2278954a-7605-426a-ae85-1bf0a311742011
197392baclofen 20 MG Oral TabletPSNae732bdc-5178-4565-8219-d1787a5211a611
197391baclofen 10 MG Oral TabletSCD2278954a-7605-426a-ae85-1bf0a311742011
197391baclofen 10 MG Oral TabletSCDae732bdc-5178-4565-8219-d1787a5211a611
197392baclofen 20 MG Oral TabletSCD2278954a-7605-426a-ae85-1bf0a311742011
197392baclofen 20 MG Oral TabletSCDae732bdc-5178-4565-8219-d1787a5211a611

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6475-6100904647561100 BLISTER PACK in 1 CARTON (0904-6475-61) / 1 TABLET in 1 BLISTER PACK100 blister pack2015-07-152027-05-31NoNoCurrent