FDA.reportPublic FDA data

Baclofen

Product NDC
0527-1337
11-digit product format
005271337
Labeler code
0527
Product ID
0527-1337_153f6bd7-9462-4d92-b738-48e7807c5919
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
baclofen
Dosage form
TABLET
Route
ORAL
Labeler
Lannett Company, Inc.
Application
ANDA077241
Marketing category
ANDA
Marketing start
2005-12-20
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
Rxcui197391, 197392, 430902

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
0527-1337-01Baclofen100 in 1 BOTTLE, PLASTICTABLET10019
0527-1337-05Baclofen500 in 1 BOTTLE, PLASTICTABLET50019
0527-1337-10Baclofen1000 in 1 BOTTLE, PLASTICTABLET100019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0527-1337-01EA - Each0527-13372cbc9d0c-23bf-4a2c-b2ec-358b2505ac8912012-07-24
0527-1337-05EA - Each0527-133744226c52-eb50-4c57-8c1a-7782c22eb86d12012-07-24
0527-1337-10EA - Each0527-13379bd82573-b99e-4818-bf29-c81fc8e7e13812020-05-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BACLOFENACTIVE INGREDIENTH789N3FKE8BACLOFEN TABLET [LANNETT COMPANY, INC.]9
BACLOFENACTIVE MOIETYH789N3FKE8BACLOFEN TABLET [LANNETT COMPANY, INC.]9
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBACLOFEN TABLET [LANNETT COMPANY, INC.]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BACLOFEN TABLET [LANNETT COMPANY, INC.]9
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BACLOFEN TABLET [LANNETT COMPANY, INC.]9
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBACLOFEN TABLET [LANNETT COMPANY, INC.]9
BACLOFENACTIVE INGREDIENTH789N3FKE8BACLOFEN TABLET [DIRECT RX]2
BACLOFENACTIVE INGREDIENTH789N3FKE8BACLOFEN TABLET [PROFICIENT RX LP]2
BACLOFENACTIVE MOIETYH789N3FKE8BACLOFEN TABLET [DIRECT RX]2
BACLOFENACTIVE MOIETYH789N3FKE8BACLOFEN TABLET [PROFICIENT RX LP]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBACLOFEN TABLET [DIRECT RX]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBACLOFEN TABLET [PROFICIENT RX LP]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BACLOFEN TABLET [DIRECT RX]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BACLOFEN TABLET [PROFICIENT RX LP]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BACLOFEN TABLET [DIRECT RX]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BACLOFEN TABLET [PROFICIENT RX LP]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBACLOFEN TABLET [PROFICIENT RX LP]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBACLOFEN TABLET [DIRECT RX]2
BACLOFENACTIVE INGREDIENTH789N3FKE8BACLOFEN TABLET [MAJOR PHARMACEUTICALS]1
BACLOFENACTIVE MOIETYH789N3FKE8BACLOFEN TABLET [MAJOR PHARMACEUTICALS]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBACLOFEN TABLET [MAJOR PHARMACEUTICALS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BACLOFEN TABLET [MAJOR PHARMACEUTICALS]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BACLOFEN TABLET [MAJOR PHARMACEUTICALS]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBACLOFEN TABLET [MAJOR PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0527-1337BACLOFEN TABLET [LANNETT COMPANY, INC.]19Current NDC, Legacy NDC, 3 package rows20210924_f84f3f4c-17e6-43f1-9600-63b0b175837b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197392baclofen 20 MG Oral TabletPSN9110b1cb-8604-4824-9337-84b08d41dd3c103
197392baclofen 20 MG Oral TabletSCD9110b1cb-8604-4824-9337-84b08d41dd3c103
197392baclofen 20 MG Oral TabletPSNb4506087-be24-4e76-9fb8-b07805137072102
197392baclofen 20 MG Oral TabletSCDb4506087-be24-4e76-9fb8-b07805137072102
197392baclofen 20 MG Oral TabletPSN7f27f935-b1fa-4494-9014-7f62c59bb8e3101
197392baclofen 20 MG Oral TabletSCD7f27f935-b1fa-4494-9014-7f62c59bb8e3101
197391baclofen 10 MG Oral TabletPSNcfcf519f-5d15-431d-89c8-961a0c38ba6026
197392baclofen 20 MG Oral TabletPSNcfcf519f-5d15-431d-89c8-961a0c38ba6026
197391baclofen 10 MG Oral TabletSCDcfcf519f-5d15-431d-89c8-961a0c38ba6026
197392baclofen 20 MG Oral TabletSCDcfcf519f-5d15-431d-89c8-961a0c38ba6026
197391baclofen 10 MG Oral TabletPSNf84f3f4c-17e6-43f1-9600-63b0b175837b19
197392baclofen 20 MG Oral TabletPSNf84f3f4c-17e6-43f1-9600-63b0b175837b19
430902baclofen 5 MG Oral TabletPSNf84f3f4c-17e6-43f1-9600-63b0b175837b19
197391baclofen 10 MG Oral TabletSCDf84f3f4c-17e6-43f1-9600-63b0b175837b19
197392baclofen 20 MG Oral TabletSCDf84f3f4c-17e6-43f1-9600-63b0b175837b19
430902baclofen 5 MG Oral TabletSCDf84f3f4c-17e6-43f1-9600-63b0b175837b19
197392baclofen 20 MG Oral TabletPSNd7b7c365-0093-4c98-84b1-e1742ce3a08f14
197392baclofen 20 MG Oral TabletSCDd7b7c365-0093-4c98-84b1-e1742ce3a08f14
197391baclofen 10 MG Oral TabletPSNae732bdc-5178-4565-8219-d1787a5211a611
197392baclofen 20 MG Oral TabletPSN58816b46-28a5-48e2-b89d-98df6593938611
197392baclofen 20 MG Oral TabletPSNae732bdc-5178-4565-8219-d1787a5211a611
197391baclofen 10 MG Oral TabletSCDae732bdc-5178-4565-8219-d1787a5211a611
197392baclofen 20 MG Oral TabletSCDae732bdc-5178-4565-8219-d1787a5211a611
197392baclofen 20 MG Oral TabletSCD58816b46-28a5-48e2-b89d-98df6593938611
197391baclofen 10 MG Oral TabletPSN924a01fb-0ed0-4f73-9304-d6c5b9961d668
197392baclofen 20 MG Oral TabletPSN924a01fb-0ed0-4f73-9304-d6c5b9961d668
197391baclofen 10 MG Oral TabletSCD924a01fb-0ed0-4f73-9304-d6c5b9961d668
197392baclofen 20 MG Oral TabletSCD924a01fb-0ed0-4f73-9304-d6c5b9961d668
197392baclofen 20 MG Oral TabletPSNb4f2f888-979a-6f54-e053-2a95a90a95a37
197392baclofen 20 MG Oral TabletSCDb4f2f888-979a-6f54-e053-2a95a90a95a37
197392baclofen 20 MG Oral TabletPSN7d164f22-a8d8-4ad1-9ea2-f29cc73b7ec86
197392baclofen 20 MG Oral TabletSCD7d164f22-a8d8-4ad1-9ea2-f29cc73b7ec86
197392baclofen 20 MG Oral TabletPSN8ed82315-6003-8308-e053-2995a90a0d4d3
197392baclofen 20 MG Oral TabletSCD8ed82315-6003-8308-e053-2995a90a0d4d3
197392baclofen 20 MG Oral TabletPSN9adb5c2f-69b7-4c26-e053-2995a90aa4af1
197392baclofen 20 MG Oral TabletSCD9adb5c2f-69b7-4c26-e053-2995a90aa4af1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0527-1337-0100527133701100 TABLET in 1 BOTTLE, PLASTIC (0527-1337-01) 100 tablet2005-12-200000-00-00NoNoCurrent
0527-1337-0500527133705500 TABLET in 1 BOTTLE, PLASTIC (0527-1337-05) 500 tablet2005-12-200000-00-00NoNoCurrent
0527-1337-10005271337101000 TABLET in 1 BOTTLE, PLASTIC (0527-1337-10) 1000 tablet2005-12-200000-00-00NoNoCurrent