FDA.reportPublic FDA data

Baclofen

Product NDC
71335-1796
11-digit product format
713351796
Labeler code
71335
Product ID
71335-1796_3de283fd-d1f2-4b9e-ac40-cf4cd85e5684
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Baclofen
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA212378
Marketing category
ANDA
Marketing start
2020-10-14
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
Rxcui197392

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
71335-1796-0Baclofen120 in 1 BOTTLETABLET120103
71335-1796-1Baclofen90 in 1 BOTTLETABLET90103
71335-1796-2Baclofen20 in 1 BOTTLETABLET20103
71335-1796-3Baclofen60 in 1 BOTTLETABLET60103
71335-1796-4Baclofen45 in 1 BOTTLETABLET45103
71335-1796-5Baclofen112 in 1 BOTTLETABLET112103
71335-1796-6Baclofen30 in 1 BOTTLETABLET30103
71335-1796-7Baclofen56 in 1 BOTTLETABLET56103
71335-1796-8Baclofen15 in 1 BOTTLETABLET15103
71335-1796-9Baclofen84 in 1 BOTTLETABLET84103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1796-1EA - Each71335-17960cbf7d41-45d7-4135-bd2b-e5401aee008e12022-01-06
71335-1796-3EA - Each71335-1796ba30de65-d42c-4604-aa0d-33f8f87229c312022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1796BACLOFEN TABLET [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 10 package rows20240524_808113db-c5c2-404c-ab5f-62b991641cfe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197392baclofen 20 MG Oral TabletPSN808113db-c5c2-404c-ab5f-62b991641cfe103
197392baclofen 20 MG Oral TabletSCD808113db-c5c2-404c-ab5f-62b991641cfe103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1796-071335179600120 TABLET in 1 BOTTLE (71335-1796-0) 120 tablet2021-12-200000-00-00NoNoCurrent
71335-1796-17133517960190 TABLET in 1 BOTTLE (71335-1796-1) 90 tablet2021-12-200000-00-00NoNoCurrent
71335-1796-27133517960220 TABLET in 1 BOTTLE (71335-1796-2) 20 tablet2021-12-200000-00-00NoNoCurrent
71335-1796-37133517960360 TABLET in 1 BOTTLE (71335-1796-3) 60 tablet2021-12-200000-00-00NoNoCurrent
71335-1796-47133517960445 TABLET in 1 BOTTLE (71335-1796-4) 45 tablet2021-12-200000-00-00NoNoCurrent
71335-1796-571335179605112 TABLET in 1 BOTTLE (71335-1796-5) 112 tablet2021-12-200000-00-00NoNoCurrent
71335-1796-67133517960630 TABLET in 1 BOTTLE (71335-1796-6) 30 tablet2021-12-200000-00-00NoNoCurrent
71335-1796-77133517960756 TABLET in 1 BOTTLE (71335-1796-7) 56 tablet2021-12-200000-00-00NoNoCurrent
71335-1796-87133517960815 TABLET in 1 BOTTLE (71335-1796-8) 15 tablet2021-12-200000-00-00NoNoCurrent
71335-1796-97133517960984 TABLET in 1 BOTTLE (71335-1796-9) 84 tablet2021-12-200000-00-00NoNoCurrent