FDA.reportPublic FDA data

Baclofen

Product NDC
0603-2407
11-digit product format
006032407
Labeler code
0603
Product ID
0603-2407_25fe173e-f3ce-4d70-adec-7e23e455679a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Baclofen
Dosage form
TABLET
Route
ORAL
Labeler
Par Health USA, LLC
Application
ANDA077068
Marketing category
ANDA
Marketing start
2005-08-30
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
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
BACLOFEN20 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0603-2407-212022-09-23C16284748780-1e4f33bdf-adf5-d8a0-e053-dadaa90a6e4eBACLOFEN TABLETS, USP
0603-2407-282022-09-23C16284748780-1e4f33bdf-adf5-d8a0-e053-dadaa90a6e4eBACLOFEN TABLETS, USP
0603-2407-322022-09-23C16284748780-1e4f33bdf-adf5-d8a0-e053-dadaa90a6e4eBACLOFEN TABLETS, USP
0603-2407-212022-07-29C16284748780-1e4f33bdf-adf5-d8a0-e053-dadaa90a6e4eBACLOFEN TABLETS, USP
0603-2407-282022-07-29C16284748780-1e4f33bdf-adf5-d8a0-e053-dadaa90a6e4eBACLOFEN TABLETS, USP
0603-2407-322022-07-29C16284748780-1e4f33bdf-adf5-d8a0-e053-dadaa90a6e4eBACLOFEN TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0603-2407-21Baclofen100 in 1 BOTTLE, PLASTICTABLET10022
0603-2407-28Baclofen500 in 1 BOTTLE, PLASTICTABLET50022
0603-2407-32Baclofen1000 in 1 BOTTLE, PLASTICTABLET100022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0603-2407-21EA - Each0603-240722f1b4d7-d781-4297-bb0b-6c0bc704114412012-07-24
0603-2407-28EA - Each0603-240702949b78-04be-43df-9ed5-9c0c697cf64e12012-07-24
0603-2407-32EA - Each0603-2407b5842989-3859-4425-ae07-9b20876a86f912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BACLOFENACTIVE INGREDIENTH789N3FKE8BACLOFEN TABLET [QUALITEST PHARMACEUTICALS]8
BACLOFENACTIVE MOIETYH789N3FKE8BACLOFEN TABLET [QUALITEST PHARMACEUTICALS]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBACLOFEN TABLET [QUALITEST PHARMACEUTICALS]8
CROSPOVIDONEINACTIVE INGREDIENT68401960MKBACLOFEN TABLET [QUALITEST PHARMACEUTICALS]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BACLOFEN TABLET [QUALITEST PHARMACEUTICALS]8
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BACLOFEN TABLET [QUALITEST PHARMACEUTICALS]8
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBACLOFEN TABLET [QUALITEST PHARMACEUTICALS]8
BACLOFENACTIVE INGREDIENTH789N3FKE8BACLOFEN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
BACLOFENACTIVE MOIETYH789N3FKE8BACLOFEN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBACLOFEN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BACLOFEN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKBACLOFEN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BACLOFEN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBACLOFEN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
BACLOFENACTIVE INGREDIENTH789N3FKE8BACLOFEN TABLET [AIDAREX PHARMACEUTICALS LLC]1
BACLOFENACTIVE INGREDIENTH789N3FKE8BACLOFEN TABLET [DISPENSING SOLUTIONS, INC.]1
BACLOFENACTIVE MOIETYH789N3FKE8BACLOFEN TABLET [AIDAREX PHARMACEUTICALS LLC]1
BACLOFENACTIVE MOIETYH789N3FKE8BACLOFEN TABLET [DISPENSING SOLUTIONS, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBACLOFEN TABLET [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBACLOFEN TABLET [DISPENSING SOLUTIONS, INC.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKBACLOFEN TABLET [AIDAREX PHARMACEUTICALS LLC]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKBACLOFEN TABLET [DISPENSING SOLUTIONS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BACLOFEN TABLET [DISPENSING SOLUTIONS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BACLOFEN TABLET [AIDAREX PHARMACEUTICALS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BACLOFEN TABLET [AIDAREX PHARMACEUTICALS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BACLOFEN TABLET [DISPENSING SOLUTIONS, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBACLOFEN TABLET [AIDAREX PHARMACEUTICALS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBACLOFEN TABLET [DISPENSING SOLUTIONS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0603-2407BACLOFEN TABLET [ENDO USA, INC.]21Current NDC, Legacy NDC, 3 package rows20250109_c17527be-661d-42f5-b6f6-56a681ba7870.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197392baclofen 20 MG Oral TabletPSNe13c0563-0f32-4199-acb0-ad2376ec951b104
197392baclofen 20 MG Oral TabletPSN32525b4e-6384-49e1-a66d-abe45484ab86104
197392baclofen 20 MG Oral TabletSCDe13c0563-0f32-4199-acb0-ad2376ec951b104
197392baclofen 20 MG Oral TabletSCD32525b4e-6384-49e1-a66d-abe45484ab86104
197392baclofen 20 MG Oral TabletPSN7b6d33d8-58c2-448d-a8df-1de7339b1520101
197392baclofen 20 MG Oral TabletSCD7b6d33d8-58c2-448d-a8df-1de7339b1520101
197391baclofen 10 MG Oral TabletPSNc17527be-661d-42f5-b6f6-56a681ba787022
197392baclofen 20 MG Oral TabletPSNc17527be-661d-42f5-b6f6-56a681ba787022
197391baclofen 10 MG Oral TabletSCDc17527be-661d-42f5-b6f6-56a681ba787022
197392baclofen 20 MG Oral TabletSCDc17527be-661d-42f5-b6f6-56a681ba787022
197392baclofen 20 MG Oral TabletPSN1f566955-2942-4d9a-a030-fcce4c47fd258
197392baclofen 20 MG Oral TabletSCD1f566955-2942-4d9a-a030-fcce4c47fd258
197391baclofen 10 MG Oral TabletPSN0308ca55-2461-4500-8e35-1d26282d36792
197392baclofen 20 MG Oral TabletPSN0308ca55-2461-4500-8e35-1d26282d36792
197391baclofen 10 MG Oral TabletSCD0308ca55-2461-4500-8e35-1d26282d36792
197392baclofen 20 MG Oral TabletSCD0308ca55-2461-4500-8e35-1d26282d36792
197391baclofen 10 MG Oral TabletPSNb127bc0c-6e3b-4906-ab5f-6992a97750381
197391baclofen 10 MG Oral TabletPSN2a7e8eb1-6a38-47b1-bc2b-b59f709f8cda1
197392baclofen 20 MG Oral TabletPSNb127bc0c-6e3b-4906-ab5f-6992a97750381
197392baclofen 20 MG Oral TabletPSN2a7e8eb1-6a38-47b1-bc2b-b59f709f8cda1
197392baclofen 20 MG Oral TabletPSNf0603733-ecaa-4e4d-a409-4a1599f547001
197391baclofen 10 MG Oral TabletSCD2a7e8eb1-6a38-47b1-bc2b-b59f709f8cda1
197391baclofen 10 MG Oral TabletSCDb127bc0c-6e3b-4906-ab5f-6992a97750381
197392baclofen 20 MG Oral TabletSCDb127bc0c-6e3b-4906-ab5f-6992a97750381
197392baclofen 20 MG Oral TabletSCD2a7e8eb1-6a38-47b1-bc2b-b59f709f8cda1
197392baclofen 20 MG Oral TabletSCDf0603733-ecaa-4e4d-a409-4a1599f547001

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0603-2407-2100603240721100 TABLET in 1 BOTTLE, PLASTIC (0603-2407-21) 100 tablet2005-08-300000-00-00NoNoCurrent
0603-2407-2800603240728500 TABLET in 1 BOTTLE, PLASTIC (0603-2407-28) 500 tablet2005-08-300000-00-00NoNoCurrent
0603-2407-32006032407321000 TABLET in 1 BOTTLE, PLASTIC (0603-2407-32) 1000 tablet2005-08-300000-00-00NoNoCurrent