FDA.reportPublic FDA data

Baclofen

Product NDC
71930-066
11-digit product format
719300066
Labeler code
71930
Product ID
71930-066_7d9fb520-b11c-4e80-b2c8-1f642d5e78d4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Baclofen
Dosage form
TABLET
Route
ORAL
Labeler
Eywa Pharma Inc
Application
ANDA211555
Marketing category
ANDA
Marketing start
2021-05-27
Substance
BACLOFEN
Active strength
5 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
BACLOFEN5 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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
eeec0918-7a2f-44bf-83d6-1216e507adbfProduct name320191217
a5300adb-f538-4abb-a49e-f8f0b8d9ac75Product name120190611
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71930-066-122024-01-30C16284748780-11030e365-625f-111a-e063-dadaa90a10e2BACLOFEN TABLETS USP Rx only
71930-066-132024-01-30C16284748780-11030e365-625f-111a-e063-dadaa90a10e2BACLOFEN TABLETS USP Rx only
71930-066-522024-01-30C16284748780-11030e365-625f-111a-e063-dadaa90a10e2BACLOFEN TABLETS USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71930-066-12Baclofen100 in 1 BOTTLETABLET1006
71930-066-13Baclofen1000 in 1 BOTTLETABLET10006
71930-066-52Baclofen500 in 1 BOTTLETABLET5006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71930-066-12EA - Each71930-0665ebe576e-919b-415e-be49-1ee84f75868812022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71930-066BACLOFEN TABLET [EYWA PHARMA INC]5Current NDC, Legacy NDC, 3 package rows20220312_7ec59f6b-7c4f-432d-ba27-442861806b6c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197391baclofen 10 MG Oral TabletPSN7ec59f6b-7c4f-432d-ba27-442861806b6c6
197392baclofen 20 MG Oral TabletPSN7ec59f6b-7c4f-432d-ba27-442861806b6c6
430902baclofen 5 MG Oral TabletPSN7ec59f6b-7c4f-432d-ba27-442861806b6c6
197391baclofen 10 MG Oral TabletSCD7ec59f6b-7c4f-432d-ba27-442861806b6c6
197392baclofen 20 MG Oral TabletSCD7ec59f6b-7c4f-432d-ba27-442861806b6c6
430902baclofen 5 MG Oral TabletSCD7ec59f6b-7c4f-432d-ba27-442861806b6c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71930-066-1271930006612100 TABLET in 1 BOTTLE (71930-066-12) 100 tablet2021-05-270000-00-00NoNoCurrent
71930-066-13719300066131000 TABLET in 1 BOTTLE (71930-066-13) 1000 tablet2021-05-270000-00-00NoNoCurrent
71930-066-5271930006652500 TABLET in 1 BOTTLE (71930-066-52) 500 tablet2021-05-270000-00-00NoNoCurrent