FDA.reportPublic FDA data

BACLOFEN

Product NDC
71335-0949
11-digit product format
713350949
Labeler code
71335
Product ID
71335-0949_b1a443f7-54c7-4f66-9389-9bcbf7abcd62
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BACLOFEN
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA209102
Marketing category
ANDA
Marketing start
2018-04-01
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
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71335-0949-02024-05-30C16284748780-11030e365-6e5e-111a-e063-dadaa90a10e2BACLOFEN TABLETS, USP Rx only
71335-0949-12024-05-30C16284748780-11030e365-6e5e-111a-e063-dadaa90a10e2BACLOFEN TABLETS, USP Rx only
71335-0949-22024-05-30C16284748780-11030e365-6e5e-111a-e063-dadaa90a10e2BACLOFEN TABLETS, USP Rx only
71335-0949-32024-05-30C16284748780-11030e365-6e5e-111a-e063-dadaa90a10e2BACLOFEN TABLETS, USP Rx only
71335-0949-42024-05-30C16284748780-11030e365-6e5e-111a-e063-dadaa90a10e2BACLOFEN TABLETS, USP Rx only
71335-0949-52024-05-30C16284748780-11030e365-6e5e-111a-e063-dadaa90a10e2BACLOFEN TABLETS, USP Rx only
71335-0949-62024-05-30C16284748780-11030e365-6e5e-111a-e063-dadaa90a10e2BACLOFEN TABLETS, USP Rx only
71335-0949-72024-05-30C16284748780-11030e365-6e5e-111a-e063-dadaa90a10e2BACLOFEN TABLETS, USP Rx only
71335-0949-82024-05-30C16284748780-11030e365-6e5e-111a-e063-dadaa90a10e2BACLOFEN TABLETS, USP Rx only
71335-0949-92024-05-30C16284748780-11030e365-6e5e-111a-e063-dadaa90a10e2BACLOFEN TABLETS, USP Rx only
71335-0949-02024-01-30C16284748780-11030e365-6e5e-111a-e063-dadaa90a10e2BACLOFEN TABLETS, USP Rx only
71335-0949-12024-01-30C16284748780-11030e365-6e5e-111a-e063-dadaa90a10e2BACLOFEN TABLETS, USP Rx only
71335-0949-22024-01-30C16284748780-11030e365-6e5e-111a-e063-dadaa90a10e2BACLOFEN TABLETS, USP Rx only
71335-0949-32024-01-30C16284748780-11030e365-6e5e-111a-e063-dadaa90a10e2BACLOFEN TABLETS, USP Rx only
71335-0949-42024-01-30C16284748780-11030e365-6e5e-111a-e063-dadaa90a10e2BACLOFEN TABLETS, USP Rx only
71335-0949-52024-01-30C16284748780-11030e365-6e5e-111a-e063-dadaa90a10e2BACLOFEN TABLETS, USP Rx only
71335-0949-62024-01-30C16284748780-11030e365-6e5e-111a-e063-dadaa90a10e2BACLOFEN TABLETS, USP Rx only
71335-0949-72024-01-30C16284748780-11030e365-6e5e-111a-e063-dadaa90a10e2BACLOFEN TABLETS, USP Rx only
71335-0949-82024-01-30C16284748780-11030e365-6e5e-111a-e063-dadaa90a10e2BACLOFEN TABLETS, USP Rx only
71335-0949-92024-01-30C16284748780-11030e365-6e5e-111a-e063-dadaa90a10e2BACLOFEN TABLETS, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0949-0BACLOFEN120 in 1 BOTTLETABLET1205
71335-0949-1BACLOFEN90 in 1 BOTTLETABLET905
71335-0949-2BACLOFEN20 in 1 BOTTLETABLET205
71335-0949-3BACLOFEN60 in 1 BOTTLETABLET605
71335-0949-4BACLOFEN45 in 1 BOTTLETABLET455
71335-0949-5BACLOFEN112 in 1 BOTTLETABLET1125
71335-0949-6BACLOFEN30 in 1 BOTTLETABLET305
71335-0949-7BACLOFEN56 in 1 BOTTLETABLET565
71335-0949-8BACLOFEN15 in 1 BOTTLETABLET155
71335-0949-9BACLOFEN84 in 1 BOTTLETABLET845

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0949-0EA - Each71335-09497e235f85-1b17-4928-b3e5-c4c85ccbc0f312020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0949BACLOFEN TABLET [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 10 package rows20240601_adc072b9-e48b-470d-9eb1-fd7b52c1f122.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197392baclofen 20 MG Oral TabletPSNadc072b9-e48b-470d-9eb1-fd7b52c1f1225
197392baclofen 20 MG Oral TabletSCDadc072b9-e48b-470d-9eb1-fd7b52c1f1225

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0949-071335094900120 TABLET in 1 BOTTLE (71335-0949-0) 120 tablet2018-10-310000-00-00NoNoCurrent
71335-0949-17133509490190 TABLET in 1 BOTTLE (71335-0949-1) 90 tablet2018-09-110000-00-00NoNoCurrent
71335-0949-27133509490220 TABLET in 1 BOTTLE (71335-0949-2) 20 tablet2024-05-290000-00-00NoNoCurrent
71335-0949-37133509490360 TABLET in 1 BOTTLE (71335-0949-3) 60 tablet2018-10-050000-00-00NoNoCurrent
71335-0949-47133509490445 TABLET in 1 BOTTLE (71335-0949-4) 45 tablet2024-05-290000-00-00NoNoCurrent
71335-0949-571335094905112 TABLET in 1 BOTTLE (71335-0949-5) 112 tablet2024-05-290000-00-00NoNoCurrent
71335-0949-67133509490630 TABLET in 1 BOTTLE (71335-0949-6) 30 tablet2018-09-060000-00-00NoNoCurrent
71335-0949-77133509490756 TABLET in 1 BOTTLE (71335-0949-7) 56 tablet2024-05-290000-00-00NoNoCurrent
71335-0949-87133509490815 TABLET in 1 BOTTLE (71335-0949-8) 15 tablet2024-05-290000-00-00NoNoCurrent
71335-0949-97133509490984 TABLET in 1 BOTTLE (71335-0949-9) 84 tablet2024-05-290000-00-00NoNoCurrent