FDA.reportPublic FDA data

BACLOFEN

Product NDC
61919-026
11-digit product format
619190026
Labeler code
61919
Product ID
61919-026_9c5970fb-9bc3-6e87-e053-2a95a90a6889
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BACLOFEN
Dosage form
TABLET
Route
ORAL
Labeler
Direct Rx
Application
ANDA072234
Marketing category
ANDA
Marketing start
2014-01-01
Marketing end
0000-00-00
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
2021-12-31
Current FDA listing
Historical FDA.report record

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
61919-026-302025-01-31C16284748780-1f386c649-d4a8-0266-e053-dadaa90a7c1aBACLOFEN
61919-026-602025-01-31C16284748780-1f386c649-d4a8-0266-e053-dadaa90a7c1aBACLOFEN
61919-026-902025-01-31C16284748780-1f386c649-d4a8-0266-e053-dadaa90a7c1aBACLOFEN
61919-026-902023-02-02C16284748780-1f386c649-d4a8-0266-e053-dadaa90a7c1aBACLOFEN
61919-026-902023-01-30C16284748780-1f386c649-d4a8-0266-e053-dadaa90a7c1aBACLOFEN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-026-30BACLOFEN30 in 1 BOTTLETABLET305
61919-026-60BACLOFEN60 in 1 BOTTLETABLET605
61919-026-90BACLOFEN90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-026-30EA - Each61919-0267b9b9b6b-fe89-456a-b2a8-a161d002b19912014-05-02
61919-026-60EA - Each61919-026f3e571c6-a3ce-47c0-a26e-9ce475d82e7212014-05-02
61919-026-90EA - Each61919-0260f8ff810-4850-42a7-9173-c479a972813f12014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BACLOFENACTIVE INGREDIENTH789N3FKE8BACLOFEN TABLET [DIRECT RX]1
BACLOFENACTIVE MOIETYH789N3FKE8BACLOFEN TABLET [DIRECT RX]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKBACLOFEN TABLET [DIRECT RX]1
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPBACLOFEN TABLET [DIRECT RX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBACLOFEN TABLET [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BACLOFEN TABLET [DIRECT RX]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BACLOFEN TABLET [DIRECT RX]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2BACLOFEN TABLET [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-026BACLOFEN TABLET [DIRECT_RX]5Legacy NDC, 3 package rows20230208_19ec8066-f0e7-4f80-b596-abe7b1ad92cb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197391baclofen 10 MG Oral TabletPSN19ec8066-f0e7-4f80-b596-abe7b1ad92cb5
197391baclofen 10 MG Oral TabletSCD19ec8066-f0e7-4f80-b596-abe7b1ad92cb5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-026-306191900263030 in 1 BOTTLEHistorical
61919-026-606191900266060 in 1 BOTTLEHistorical
61919-026-906191900269090 BOTTLE in 1 BOTTLE (61919-026-90) > 60 BOTTLE in 1 BOTTLE (61919-026-60) > 30 TABLET in 1 BOTTLE (61919-026-30) 90 bottle2015-01-010000-00-00NoNoCurrent