FDA.reportPublic FDA data

Baclofen

Product NDC
72162-2450
11-digit product format
721622450
Labeler code
72162
Product ID
72162-2450_35a07616-7bb5-4dd0-989a-1c02dd5f36ef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Baclofen
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA212067
Marketing category
ANDA
Marketing start
2020-07-09
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
72162-2450-0Baclofen1000 in 1 BOTTLETABLET1000101
72162-2450-1Baclofen100 in 1 BOTTLETABLET100101
72162-2450-2Baclofen120 in 1 BOTTLETABLET120101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2450-0EA - Each72162-2450a66fdfd7-24f1-4a69-95be-f4f3bf3fc7f812025-05-14
72162-2450-1EA - Each72162-2450191adecf-e98c-4fce-89c8-22993d0f504012025-05-14
72162-2450-2EA - Each72162-2450c01c0651-eafd-4e9a-a7c9-c5712bc2794712025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2450BACLOFEN TABLET [BRYANT RANCH PREPACK]101Current NDC, 3 package rows20250224_8cb96e7b-9c40-46a9-b964-7a573b7a0342.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197392baclofen 20 MG Oral TabletPSN8cb96e7b-9c40-46a9-b964-7a573b7a0342101
197392baclofen 20 MG Oral TabletSCD8cb96e7b-9c40-46a9-b964-7a573b7a0342101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2450-0721622450001000 TABLET in 1 BOTTLE (72162-2450-0) 1000 tablet2025-01-22NoNoHistorical
72162-2450-172162245001100 TABLET in 1 BOTTLE (72162-2450-1) 100 tablet2025-01-22NoNoHistorical
72162-2450-272162245002120 TABLET in 1 BOTTLE (72162-2450-2) 120 tablet2025-01-22NoNoHistorical