FDA.reportPublic FDA data

BACLOFEN

Product NDC
16571-171
11-digit product format
165710171
Labeler code
16571
Product ID
16571-171_ff66a259-5803-47a3-9558-87acf43f43a7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BACLOFEN
Dosage form
TABLET
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA214374
Marketing category
ANDA
Marketing start
2024-03-01
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, 197392, 430902

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
16571-171-01BACLOFEN100 in 1 BOTTLETABLET1001
16571-171-10BACLOFEN1000 in 1 BOTTLETABLET10001
16571-171-50BACLOFEN500 in 1 BOTTLETABLET5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-171BACLOFEN TABLET [RISING PHARMA HOLDINGS, INC.]1Current NDC, 3 package rows20240402_6eb46715-d72b-473f-b984-90024033d4a0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197391baclofen 10 MG Oral TabletPSN2517f71f-f452-1f56-e063-6394a90a6ef14
197391baclofen 10 MG Oral TabletSCD2517f71f-f452-1f56-e063-6394a90a6ef14
197391baclofen 10 MG Oral TabletPSN5e479876-adfb-4590-ac10-3924ff7988b03
197391baclofen 10 MG Oral TabletSCD5e479876-adfb-4590-ac10-3924ff7988b03
197391baclofen 10 MG Oral TabletPSN6eb46715-d72b-473f-b984-90024033d4a01
197391baclofen 10 MG Oral TabletPSNab3760cd-a84b-49ba-88e3-b9ea73c55f821
197392baclofen 20 MG Oral TabletPSN6eb46715-d72b-473f-b984-90024033d4a01
430902baclofen 5 MG Oral TabletPSN6eb46715-d72b-473f-b984-90024033d4a01
197391baclofen 10 MG Oral TabletSCD6eb46715-d72b-473f-b984-90024033d4a01
197391baclofen 10 MG Oral TabletSCDab3760cd-a84b-49ba-88e3-b9ea73c55f821
197392baclofen 20 MG Oral TabletSCD6eb46715-d72b-473f-b984-90024033d4a01
430902baclofen 5 MG Oral TabletSCD6eb46715-d72b-473f-b984-90024033d4a01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
16571-171-0116571017101100 TABLET in 1 BOTTLE (16571-171-01) 100 tablet2024-03-01NoNoCurrent
16571-171-10165710171101000 TABLET in 1 BOTTLE (16571-171-10) 1000 tablet2024-03-01NoNoCurrent
16571-171-5016571017150500 TABLET in 1 BOTTLE (16571-171-50) 500 tablet2024-03-01NoNoCurrent