FDA.reportPublic FDA data

BACLOFEN

Product NDC
72888-009
11-digit product format
728880009
Labeler code
72888
Product ID
72888-009_490e18d8-694e-da7b-e063-6294a90ab450
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BACLOFEN
Dosage form
TABLET
Route
ORAL
Labeler
Advagen Pharma Limited
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
Rxcui197391, 197392, 430902, 2679605

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
72888-009-01BACLOFEN100 in 1 BOTTLETABLET1007
72888-009-05BACLOFEN500 in 1 BOTTLETABLET5007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72888-009-01EA - Each72888-009e99ac251-7f58-4d3f-8a99-2dce8b9dfac812021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72888-009BACLOFEN TABLET [ADVAGEN PHARMA LIMITED]5Current NDC, Legacy NDC, 2 package rows20230706_04dac0f6-cc6c-4959-9bca-a6e4a99690f3.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
197391baclofen 10 MG Oral TabletPSN04dac0f6-cc6c-4959-9bca-a6e4a99690f37
2679605baclofen 15 MG Oral TabletPSN04dac0f6-cc6c-4959-9bca-a6e4a99690f37
197392baclofen 20 MG Oral TabletPSN04dac0f6-cc6c-4959-9bca-a6e4a99690f37
430902baclofen 5 MG Oral TabletPSN04dac0f6-cc6c-4959-9bca-a6e4a99690f37
197391baclofen 10 MG Oral TabletSCD04dac0f6-cc6c-4959-9bca-a6e4a99690f37
2679605baclofen 15 MG Oral TabletSCD04dac0f6-cc6c-4959-9bca-a6e4a99690f37
197392baclofen 20 MG Oral TabletSCD04dac0f6-cc6c-4959-9bca-a6e4a99690f37
430902baclofen 5 MG Oral TabletSCD04dac0f6-cc6c-4959-9bca-a6e4a99690f37
2679605baclofen 15 MG Oral TabletSY04dac0f6-cc6c-4959-9bca-a6e4a99690f37
430902baclofen 5 MG Oral TabletPSN46f84504-ffc4-4be5-9598-c20a3f4210f43
430902baclofen 5 MG Oral TabletSCD46f84504-ffc4-4be5-9598-c20a3f4210f43
430902baclofen 5 MG Oral TabletPSNe017a001-8cb1-4dd8-960e-c6d74005f57f1
430902baclofen 5 MG Oral TabletSCDe017a001-8cb1-4dd8-960e-c6d74005f57f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72888-009-0172888000901100 TABLET in 1 BOTTLE (72888-009-01) 100 tablet2018-04-010000-00-00NoNoCurrent
72888-009-0572888000905500 TABLET in 1 BOTTLE (72888-009-05) 500 tablet2018-04-01NoNoCurrent