FDA.reportPublic FDA data

BACLOFEN

Product NDC
72789-478
11-digit product format
727890478
Labeler code
72789
Product ID
72789-478_4ddfe373-21fb-4f15-e063-6294a90a7d38
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BACLOFEN
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA209102
Marketing category
ANDA
Marketing start
2018-04-01
Substance
BACLOFEN
Active strength
5 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
BACLOFEN
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACLOFEN5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiH789N3FKE8
Rxcui430902

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
72789-478-01BACLOFEN100 in 1 BOTTLE, PLASTICTABLET10010
72789-478-30BACLOFEN30 in 1 BOTTLE, PLASTICTABLET3010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-478-01EA - Each72789-478cda1f712-d532-4543-8807-130274548fbb12025-02-10
72789-478-30EA - Each72789-478b7986433-54aa-4505-85db-af2e2cfe166b12025-10-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-478BACLOFEN TABLET [PD-RX PHARMACEUTICALS, INC.]6Current NDC, 2 package rows20250122_91175128-8285-4d04-89a9-219781be9260.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
430902baclofen 5 MG Oral TabletPSN91175128-8285-4d04-89a9-219781be926010
430902baclofen 5 MG Oral TabletSCD91175128-8285-4d04-89a9-219781be926010

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72789-478-0172789047801100 TABLET in 1 BOTTLE, PLASTIC (72789-478-01) 100 tablet2025-01-21NoNoCurrent
72789-478-307278904783030 TABLET in 1 BOTTLE, PLASTIC (72789-478-30) 30 tablet2025-08-28NoNoCurrent