FDA.reportPublic FDA data

Baclofen

Product NDC
71610-446
11-digit product format
716100446
Labeler code
71610
Product ID
71610-446_edf4b7c6-f843-4177-ba85-410ad266ba81
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Baclofen
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA078401
Marketing category
ANDA
Marketing start
2011-01-01
Substance
BACLOFEN
Active strength
20 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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACLOFEN20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiH789N3FKE8
Rxcui197392

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
71610-446-45Baclofen45 in 1 BOTTLETABLET452
71610-446-60Baclofen90 in 1 BOTTLETABLET902
71610-446-92Baclofen270 in 1 BOTTLETABLET2702

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-446-45EA - Each71610-4463bcba910-4241-4946-817d-34230c49abee12020-09-14
71610-446-60EA - Each71610-44615444705-9850-4304-844f-530d196525c212020-09-14
71610-446-92EA - Each71610-4469f785401-704f-4be3-9091-d915759ff9c112020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-446BACLOFEN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, Legacy NDC, 3 package rows20200814_9edc00c6-c281-4e81-b176-44b7536f71f2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197392baclofen 20 MG Oral TabletPSN9edc00c6-c281-4e81-b176-44b7536f71f22
197392baclofen 20 MG Oral TabletSCD9edc00c6-c281-4e81-b176-44b7536f71f22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-446-457161004464545 TABLET in 1 BOTTLE (71610-446-45) 45 tablet2020-07-210000-00-00NoNoCurrent
71610-446-607161004466090 TABLET in 1 BOTTLE (71610-446-60) 90 tablet2020-07-210000-00-00NoNoCurrent
71610-446-9271610044692270 TABLET in 1 BOTTLE (71610-446-92) 270 tablet2020-07-300000-00-00NoNoCurrent