FDA.reportPublic FDA data

BACLOFEN

Product NDC
72789-312
11-digit product format
727890312
Labeler code
72789
Product ID
72789-312_40bb0acb-4bbf-f606-e063-6294a90a07d0
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
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
72789-312-30BACLOFEN30 in 1 BOTTLE, PLASTICTABLET307
72789-312-90BACLOFEN90 in 1 BOTTLE, PLASTICTABLET907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-312-30EA - Each72789-31222765a35-bfe3-48cf-af49-666269e0c0d412023-04-07
72789-312-90EA - Each72789-312c99c62c3-e4c8-460b-bcc4-dcba24e79ebb12023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-312BACLOFEN TABLET [PD-RX PHARMACEUTICALS, INC.]6Current NDC, 2 package rows20240720_5cba5255-e5ad-48fd-8385-60e9ea6b6407.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197392baclofen 20 MG Oral TabletPSN5cba5255-e5ad-48fd-8385-60e9ea6b64077
197392baclofen 20 MG Oral TabletSCD5cba5255-e5ad-48fd-8385-60e9ea6b64077

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72789-312-307278903123030 TABLET in 1 BOTTLE, PLASTIC (72789-312-30) 30 tablet2023-03-15NoNoHistorical
72789-312-907278903129090 TABLET in 1 BOTTLE, PLASTIC (72789-312-90) 90 tablet2023-04-25NoNoHistorical