FDA.reportPublic FDA data

Baclofen

Product NDC
71335-2756
11-digit product format
713352756
Labeler code
71335
Product ID
71335-2756_faf7a0b9-0ca6-4265-a280-b3b5f7d270b2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Baclofen
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA212067
Marketing category
ANDA
Marketing start
2020-07-09
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2756-0Baclofen120 in 1 BOTTLETABLET1201
71335-2756-1Baclofen90 in 1 BOTTLETABLET901
71335-2756-2Baclofen20 in 1 BOTTLETABLET201
71335-2756-3Baclofen60 in 1 BOTTLETABLET601
71335-2756-4Baclofen45 in 1 BOTTLETABLET451
71335-2756-5Baclofen112 in 1 BOTTLETABLET1121
71335-2756-6Baclofen30 in 1 BOTTLETABLET301
71335-2756-7Baclofen56 in 1 BOTTLETABLET561
71335-2756-8Baclofen15 in 1 BOTTLETABLET151
71335-2756-9Baclofen84 in 1 BOTTLETABLET841

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2756-1EA - Each71335-275610860d1d-5643-4fe2-825e-7b61d02cbc6312026-01-08
71335-2756-2EA - Each71335-2756282c5684-303b-4433-801a-769aa09e781412026-01-08
71335-2756-3EA - Each71335-275626ab5f45-a1b4-4362-a015-b3c91e81b9f112026-01-08
71335-2756-6EA - Each71335-27563d9e70e9-d1ba-42db-a488-620c2f54fe6912026-01-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197392baclofen 20 MG Oral TabletPSNab5fd609-3081-4400-90cd-c83b6834d3811
197392baclofen 20 MG Oral TabletSCDab5fd609-3081-4400-90cd-c83b6834d3811

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2756-071335275600120 TABLET in 1 BOTTLE (71335-2756-0) 120 tablet2025-10-03NoNoHistorical
71335-2756-17133527560190 TABLET in 1 BOTTLE (71335-2756-1) 90 tablet2025-10-03NoNoHistorical
71335-2756-27133527560220 TABLET in 1 BOTTLE (71335-2756-2) 20 tablet2025-10-03NoNoHistorical
71335-2756-37133527560360 TABLET in 1 BOTTLE (71335-2756-3) 60 tablet2025-10-03NoNoHistorical
71335-2756-47133527560445 TABLET in 1 BOTTLE (71335-2756-4) 45 tablet2025-10-03NoNoHistorical
71335-2756-571335275605112 TABLET in 1 BOTTLE (71335-2756-5) 112 tablet2025-10-03NoNoHistorical
71335-2756-67133527560630 TABLET in 1 BOTTLE (71335-2756-6) 30 tablet2025-10-03NoNoHistorical
71335-2756-77133527560756 TABLET in 1 BOTTLE (71335-2756-7) 56 tablet2025-10-03NoNoHistorical
71335-2756-87133527560815 TABLET in 1 BOTTLE (71335-2756-8) 15 tablet2025-10-03NoNoHistorical
71335-2756-97133527560984 TABLET in 1 BOTTLE (71335-2756-9) 84 tablet2025-10-03NoNoHistorical