FDA.reportPublic FDA data

BACLOFEN

Product NDC
61919-095
11-digit product format
619190095
Labeler code
61919
Product ID
61919-095_b6739402-fd84-79d1-e053-2a95a90acc02
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BACLOFEN
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA077241
Marketing category
ANDA
Marketing start
2014-01-01
Marketing end
0000-00-00
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
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
61919-095-302025-01-30C16284748780-12cef2736-afd7-d83d-e063-dadaa90ab31fBACLOFEN
61919-095-602025-01-30C16284748780-19d75b9d0-40c6-f424-e053-dadaa90a57ceBACLOFEN
61919-095-822025-01-30C16284748780-19d75b9d0-40c6-f424-e053-dadaa90a57ceBACLOFEN
61919-095-862025-01-30C16284748780-12cef2736-afd7-d83d-e063-dadaa90ab31fBACLOFEN
61919-095-902025-01-30C16284748780-19d75b9d0-40c6-f424-e053-dadaa90a57ceBACLOFEN
61919-095-602020-12-14C16284748780-19d75b9d0-40c6-f424-e053-dadaa90a57ceBACLOFEN
61919-095-902020-12-14C16284748780-19d75b9d0-40c6-f424-e053-dadaa90a57ceBACLOFEN
61919-095-602020-01-31C16284748780-19d75b9d0-40c6-f424-e053-dadaa90a57ceBACLOFEN
61919-095-902020-01-31C16284748780-19d75b9d0-40c6-f424-e053-dadaa90a57ceBACLOFEN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-095-60BACLOFEN60 in 1 BOTTLETABLET606
61919-095-82BACLOFEN180 in 1 BOTTLETABLET1806
61919-095-90BACLOFEN90 in 1 BOTTLETABLET906
61919-095-30BACLOFEN30 in 1 BOTTLETABLET303
61919-095-86BACLOFEN270 in 1 BOTTLETABLET2703

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-095-30EA - Each61919-095ee9ef1da-9347-44f9-ae3b-9c4dc5f165a612019-08-06
61919-095-60EA - Each61919-095968d84a8-e787-45eb-bc88-c4ce446af96512015-02-02
61919-095-82EA - Each61919-095802434d2-88fb-47fb-9fd8-9eeabcd6163812024-01-04
61919-095-86EA - Each61919-095a7725d34-2fbe-4d29-8b55-c2031fd603b012019-11-12
61919-095-90EA - Each61919-0952316f0d9-e3bc-4154-bd7e-fcb3a6dd5a5412015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BACLOFENACTIVE INGREDIENTH789N3FKE8BACLOFEN TABLET [DIRECT RX]2
BACLOFENACTIVE MOIETYH789N3FKE8BACLOFEN TABLET [DIRECT RX]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBACLOFEN TABLET [DIRECT RX]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BACLOFEN TABLET [DIRECT RX]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BACLOFEN TABLET [DIRECT RX]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBACLOFEN TABLET [DIRECT RX]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-095BACLOFEN TABLET [DIRECT RX]6Legacy NDC, 3 package rows20231205_7d164f22-a8d8-4ad1-9ea2-f29cc73b7ec8.zip
61919-095BACLOFEN TABLET [DIRECT_RX]3Legacy NDC, 2 package rows20200118_8ed82315-6003-8308-e053-2995a90a0d4d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-095-306191900953030 TABLET in 1 BOTTLE (61919-095-30) 30 tablet2019-07-290000-00-00NoNoCurrent
61919-095-606191900956060 TABLET in 1 BOTTLE (61919-095-60) 60 tablet2015-04-290000-00-00NoNoCurrent
61919-095-8261919009582180 in 1 BOTTLEHistorical
61919-095-8661919009586270 TABLET in 1 BOTTLE (61919-095-86) 270 tablet2019-07-290000-00-00NoNoCurrent
61919-095-906191900959090 TABLET in 1 BOTTLE (61919-095-90) 90 tablet2015-04-290000-00-00NoNoCurrent