FDA.reportPublic FDA data

BACLOFEN

Product NDC
59651-394
11-digit product format
596510394
Labeler code
59651
Product ID
59651-394_493c1b1f-7ee0-4a54-8e44-b2b015eb3850
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BACLOFEN
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA214099
Marketing category
ANDA
Marketing start
2021-07-13
Substance
BACLOFEN
Active strength
10 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
BACLOFEN10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiH789N3FKE8
Rxcui197391, 197392

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
59651-394-01BACLOFEN100 in 1 BOTTLETABLET1003
59651-394-05BACLOFEN500 in 1 BOTTLETABLET5003
59651-394-99BACLOFEN1000 in 1 BOTTLETABLET10003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-394-01EA - Each59651-3943632a5db-41f3-442b-999d-9a70d9ffb01212021-09-07
59651-394-05EA - Each59651-3944b71ca8a-0805-4b7b-81ff-524f9b7a734812021-09-07
59651-394-99EA - Each59651-39467ceee59-01a5-4a4a-aa8d-163f91f77b5912021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-394BACLOFEN TABLET [AUROBINDO PHARMA LIMITED]2Current NDC, Legacy NDC, 3 package rows20211231_4679a275-9307-4b0f-a2eb-2d83227ea84d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197391baclofen 10 MG Oral TabletPSN3fdfeef9-68b3-4f6c-a4de-28179758a9623
197391baclofen 10 MG Oral TabletPSN4679a275-9307-4b0f-a2eb-2d83227ea84d3
197391baclofen 10 MG Oral TabletPSNea52170c-7986-21bd-e053-2a95a90a5dff3
197391baclofen 10 MG Oral TabletPSNfd00fa8f-2797-c3f0-e053-6294a90a975f3
197392baclofen 20 MG Oral TabletPSN4679a275-9307-4b0f-a2eb-2d83227ea84d3
197391baclofen 10 MG Oral TabletSCD3fdfeef9-68b3-4f6c-a4de-28179758a9623
197391baclofen 10 MG Oral TabletSCD4679a275-9307-4b0f-a2eb-2d83227ea84d3
197391baclofen 10 MG Oral TabletSCDea52170c-7986-21bd-e053-2a95a90a5dff3
197391baclofen 10 MG Oral TabletSCDfd00fa8f-2797-c3f0-e053-6294a90a975f3
197392baclofen 20 MG Oral TabletSCD4679a275-9307-4b0f-a2eb-2d83227ea84d3
197391baclofen 10 MG Oral TabletPSN687f48da-bc41-4700-9513-77a32fc86c932
197392baclofen 20 MG Oral TabletPSN687f48da-bc41-4700-9513-77a32fc86c932
197391baclofen 10 MG Oral TabletSCD687f48da-bc41-4700-9513-77a32fc86c932
197392baclofen 20 MG Oral TabletSCD687f48da-bc41-4700-9513-77a32fc86c932

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59651-394-0159651039401100 TABLET in 1 BOTTLE (59651-394-01) 100 tablet2021-07-130000-00-00NoNoCurrent
59651-394-0559651039405500 TABLET in 1 BOTTLE (59651-394-05) 500 tablet2021-07-130000-00-00NoNoCurrent
59651-394-99596510394991000 TABLET in 1 BOTTLE (59651-394-99) 1000 tablet2021-07-130000-00-00NoNoCurrent