FDA.reportPublic FDA data

Baclofen

Product NDC
71205-474
11-digit product format
712050474
Labeler code
71205
Product ID
71205-474_4702c59e-202c-4900-9388-f64788cb035c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Baclofen
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA078504
Marketing category
ANDA
Marketing start
2011-01-01
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
71205-474-14Baclofen14 in 1 BOTTLETABLET145
71205-474-20Baclofen20 in 1 BOTTLETABLET205
71205-474-30Baclofen30 in 1 BOTTLETABLET305
71205-474-60Baclofen60 in 1 BOTTLETABLET605
71205-474-72Baclofen120 in 1 BOTTLETABLET1205
71205-474-78Baclofen180 in 1 BOTTLETABLET1805
71205-474-90Baclofen90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-474-14EA - Each71205-47470875bfa-8d97-4d07-b6c6-b368179533d212022-03-09
71205-474-72EA - Each71205-4741932362e-1ae4-41b6-a367-e60438f8d5f912021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-474BACLOFEN TABLET [PROFICIENT RX LP]5Current NDC, Legacy NDC, 7 package rows20220409_b65d3089-0412-487f-a1b4-66f0bc6f398e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197391baclofen 10 MG Oral TabletPSNb65d3089-0412-487f-a1b4-66f0bc6f398e5
197391baclofen 10 MG Oral TabletSCDb65d3089-0412-487f-a1b4-66f0bc6f398e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-474-147120504741414 TABLET in 1 BOTTLE (71205-474-14) 14 tablet2022-01-050000-00-00NoNoCurrent
71205-474-207120504742020 TABLET in 1 BOTTLE (71205-474-20) 20 tablet2020-10-010000-00-00NoNoCurrent
71205-474-307120504743030 TABLET in 1 BOTTLE (71205-474-30) 30 tablet2020-08-270000-00-00NoNoCurrent
71205-474-607120504746060 TABLET in 1 BOTTLE (71205-474-60) 60 tablet2020-08-270000-00-00NoNoCurrent
71205-474-7271205047472120 TABLET in 1 BOTTLE (71205-474-72) 120 tablet2020-12-220000-00-00NoNoCurrent
71205-474-7871205047478180 TABLET in 1 BOTTLE (71205-474-78) 180 tablet2020-09-250000-00-00NoNoCurrent
71205-474-907120504749090 TABLET in 1 BOTTLE (71205-474-90) 90 tablet2020-08-270000-00-00NoNoCurrent