FDA.reportPublic FDA data

Baclofen

Product NDC
67544-671
Requested package NDC
67544-671-80
11-digit product format
675440671
Labeler code
67544
Product ID
67544-671_ba0a7c8f-e018-4e0b-97df-8e5752eb03ad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Baclofen
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA077156
Marketing category
ANDA
Marketing start
2005-08-30
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
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog.

Additional Listing Data#

Finished product
Yes
Brand name base
Baclofen
Listing expiration
2026-12-31

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
dd4b9972-0295-4555-a90b-bb087170cfbbAvailable 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
67544-671-60Baclofen90 in 1 BOTTLE, PLASTICTABLET901
67544-671-80Baclofen180 in 1 BOTTLE, PLASTICTABLET1801
67544-671-92Baclofen270 in 1 BOTTLE, PLASTICTABLET2701

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67544-671-60EA - Each67544-6714fd8817d-7da9-4f89-b0f8-248430f35d5612017-12-14
67544-671-80EA - Each67544-671e9c1e170-5afa-4a2f-9f0d-d1951a19c55f12017-12-14
67544-671-92EA - Each67544-671e8e8cdc6-3f15-4ad9-ae34-03314cfa8d6b12017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67544-671BACLOFEN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 3 package rows20171214_dd4b9972-0295-4555-a90b-bb087170cfbb.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BaclofenBACLOFENBryant Ranch Prepack7ed13ef7-329e-40cb-b9b1-31a4bf32ac982023-08-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077156
application number: ANDA077156
BaclofenBACLOFENAphena Pharma Solutions - Tennessee, LLCdd4b9972-0295-4555-a90b-bb087170cfbb2017-12-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077156
application number: ANDA077156
ndc (package): 67544-671-80
ndc (product): 67544-671
ndc11 (package): 67544067180

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197391baclofen 10 MG Oral TabletPSNdd4b9972-0295-4555-a90b-bb087170cfbb1
197391baclofen 10 MG Oral TabletSCDdd4b9972-0295-4555-a90b-bb087170cfbb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67544-671-8067544067180180 TABLET in 1 BOTTLE, PLASTIC (67544-671-80) 180 tablet2008-07-280000-00-00NoNoCurrent