FDA.reportPublic FDA data

Baclofen

Product NDC
71610-924
11-digit product format
716100924
Labeler code
71610
Product ID
71610-924_39ad3a63-fe5b-04b9-e063-6294a90a11e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Baclofen
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA215885
Marketing category
ANDA
Marketing start
2022-01-25
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

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 Identifiers#

Field, Values table
FieldValues
UniiH789N3FKE8
Rxcui197391

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
71610-924-53Baclofen60 in 1 BOTTLETABLET601
71610-924-60Baclofen90 in 1 BOTTLETABLET901
71610-924-80Baclofen180 in 1 BOTTLETABLET1801
71610-924-92Baclofen270 in 1 BOTTLETABLET2701

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-924-53EA - Each71610-924ae943a10-2239-4dce-8f77-effd10934a9b12025-08-11
71610-924-60EA - Each71610-9240613370a-cde5-4c12-8684-3d7507de290112025-08-11
71610-924-80EA - Each71610-924b0e216d4-fc41-4228-867c-4bb81bd32fbe12025-08-11
71610-924-92EA - Each71610-9245fdb312b-1047-4dc2-bb3b-4f86c70b9cc912025-08-11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197391baclofen 10 MG Oral TabletPSN39ad22ca-f034-f605-e063-6294a90a08e41
197391baclofen 10 MG Oral TabletSCD39ad22ca-f034-f605-e063-6294a90a08e41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-924-537161009245360 TABLET in 1 BOTTLE (71610-924-53) 60 tablet2025-07-09NoNoHistorical
71610-924-607161009246090 TABLET in 1 BOTTLE (71610-924-60) 90 tablet2025-07-09NoNoHistorical
71610-924-8071610092480180 TABLET in 1 BOTTLE (71610-924-80) 180 tablet2025-07-09NoNoHistorical
71610-924-9271610092492270 TABLET in 1 BOTTLE (71610-924-92) 270 tablet2025-07-09NoNoHistorical