FDA.reportPublic FDA data

Baclofen

Product NDC
71335-0344
11-digit product format
713350344
Labeler code
71335
Product ID
71335-0344_8858eea4-a4da-4add-8f5e-bb264c8e85e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
baclofen
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078220
Marketing category
ANDA
Marketing start
2007-07-01
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
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
BACLOFEN10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiH789N3FKE8
Rxcui197391

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
71335-0344-0Baclofen112 in 1 BOTTLE, PLASTICTABLET112104
71335-0344-1Baclofen30 in 1 BOTTLE, PLASTICTABLET30104
71335-0344-2Baclofen120 in 1 BOTTLE, PLASTICTABLET120104
71335-0344-3Baclofen20 in 1 BOTTLE, PLASTICTABLET20104
71335-0344-4Baclofen60 in 1 BOTTLE, PLASTICTABLET60104
71335-0344-5Baclofen100 in 1 BOTTLE, PLASTICTABLET100104
71335-0344-6Baclofen56 in 1 BOTTLE, PLASTICTABLET56104
71335-0344-7Baclofen90 in 1 BOTTLE, PLASTICTABLET90104
71335-0344-8Baclofen140 in 1 BOTTLE, PLASTICTABLET140104
71335-0344-9Baclofen84 in 1 BOTTLE, PLASTICTABLET84104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0344-0EA - Each71335-0344889fe0b4-f6ea-40e2-a615-040ac9023b4312018-01-12
71335-0344-1EA - Each71335-0344ef0efbd2-0e58-4690-88e5-eef71079543912018-01-12
71335-0344-2EA - Each71335-034498302844-2556-4d59-bb2b-5b9741313c3812018-01-12
71335-0344-3EA - Each71335-03441db56618-639d-419b-82bd-410e3206aaf812018-01-12
71335-0344-4EA - Each71335-034480c10dcb-7b2e-411e-bb83-8abfeddab37012018-01-12
71335-0344-5EA - Each71335-0344eb10b7f3-c488-4eed-8ef2-394ea611feb812018-01-12
71335-0344-6EA - Each71335-034446c907e4-3054-4fa8-b6ce-b6d55ee1927912018-01-12
71335-0344-7EA - Each71335-03449794d90e-8f06-47ef-b7a6-fc060e65ca7912018-01-12
71335-0344-8EA - Each71335-03442323a699-191c-4007-a9c9-b756101f418412018-01-12
71335-0344-9EA - Each71335-03442b13d4d3-64ef-4241-9d7a-789c68ddf32512018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0344BACLOFEN TABLET [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 10 package rows20240823_fded79a4-c354-448d-96dd-6dc69c46a013.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197391baclofen 10 MG Oral TabletPSNfded79a4-c354-448d-96dd-6dc69c46a013104
197391baclofen 10 MG Oral TabletSCDfded79a4-c354-448d-96dd-6dc69c46a013104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0344-071335034400112 TABLET in 1 BOTTLE, PLASTIC (71335-0344-0) 112 tablet2022-02-090000-00-00NoNoCurrent
71335-0344-17133503440130 TABLET in 1 BOTTLE, PLASTIC (71335-0344-1) 30 tablet2022-02-090000-00-00NoNoCurrent
71335-0344-271335034402120 TABLET in 1 BOTTLE, PLASTIC (71335-0344-2) 120 tablet2022-02-090000-00-00NoNoCurrent
71335-0344-37133503440320 TABLET in 1 BOTTLE, PLASTIC (71335-0344-3) 20 tablet2022-02-090000-00-00NoNoCurrent
71335-0344-47133503440460 TABLET in 1 BOTTLE, PLASTIC (71335-0344-4) 60 tablet2022-02-090000-00-00NoNoCurrent
71335-0344-571335034405100 TABLET in 1 BOTTLE, PLASTIC (71335-0344-5) 100 tablet2022-02-090000-00-00NoNoCurrent
71335-0344-67133503440656 TABLET in 1 BOTTLE, PLASTIC (71335-0344-6) 56 tablet2022-02-090000-00-00NoNoCurrent
71335-0344-77133503440790 TABLET in 1 BOTTLE, PLASTIC (71335-0344-7) 90 tablet2022-02-090000-00-00NoNoCurrent
71335-0344-871335034408140 TABLET in 1 BOTTLE, PLASTIC (71335-0344-8) 140 tablet2022-02-090000-00-00NoNoCurrent
71335-0344-97133503440984 TABLET in 1 BOTTLE, PLASTIC (71335-0344-9) 84 tablet2022-02-090000-00-00NoNoCurrent