FDA.reportPublic FDA data

Baclofen

Product NDC
62559-204
11-digit product format
625590204
Labeler code
62559
Product ID
62559-204_1c95cf7d-6db8-437d-9e33-f8ecb151eca6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Baclofen
Dosage form
SUSPENSION
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
ANDA217252
Marketing category
ANDA
Marketing start
2024-03-18
Substance
BACLOFEN
Active strength
5 mg/mL
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
BACLOFEN5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiH789N3FKE8
Rxcui2593376

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
62559-204-03Baclofen300 mL in 1 BOTTLESUSPENSION3002
62559-204-03Baclofen1 in 1 CARTONSUSPENSION12
62559-204-12Baclofen120 mL in 1 BOTTLESUSPENSION1202
62559-204-12Baclofen1 in 1 CARTONSUSPENSION12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62559-204-03ML - Milliliter62559-204ef7ea059-02de-494b-8160-0a926fc749a212024-05-16
62559-204-12ML - Milliliter62559-204bdbd5b04-3527-4ef5-a745-3450ee44eb2112024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62559-204BACLOFEN SUSPENSION [ANI PHARMACEUTICALS, INC.]1Current NDC, 4 package rows20240323_c73ed3af-8e8a-4a18-90fc-a0f2dcc641d0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2593376baclofen 5 MG/mL Oral SuspensionPSNc73ed3af-8e8a-4a18-90fc-a0f2dcc641d02
2593376baclofen 5 MG/ML Oral SuspensionSCDc73ed3af-8e8a-4a18-90fc-a0f2dcc641d02
2593376baclofen 25 MG per 5 ML Oral SuspensionSYc73ed3af-8e8a-4a18-90fc-a0f2dcc641d02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62559-204-03625590204031 BOTTLE in 1 CARTON (62559-204-03) / 300 mL in 1 BOTTLE1 bottle2024-03-19NoNoHistorical
62559-204-12625590204121 BOTTLE in 1 CARTON (62559-204-12) / 120 mL in 1 BOTTLE1 bottle2024-03-18NoNoHistorical