FDA.reportPublic FDA data

BACLOFEN

Product NDC
70518-3614
11-digit product format
705183614
Labeler code
70518
Product ID
70518-3614_4f6b3ea4-9fcf-af92-e063-6394a90abb28
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BACLOFEN
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA209102
Marketing category
ANDA
Marketing start
2023-01-09
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
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
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
70518-3614-0BACLOFEN30 in 1 BLISTER PACKTABLET308
70518-3614-1BACLOFEN90 in 1 BOTTLE, PLASTICTABLET908
70518-3614-2BACLOFEN30 in 1 BOTTLE, PLASTICTABLET308

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-3614-1EA - Each70518-3614bfda1458-fcf3-48cd-b519-e0c357f63b0b12026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3614BACLOFEN TABLET [REMEDYREPACK INC.]5Current NDC, Legacy NDC, 3 package rows20241122_ac9b720f-b755-49f1-9850-efb26feadaeb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197391baclofen 10 MG Oral TabletPSNac9b720f-b755-49f1-9850-efb26feadaeb8
197391baclofen 10 MG Oral TabletSCDac9b720f-b755-49f1-9850-efb26feadaeb8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3614-07051836140030 TABLET in 1 BLISTER PACK (70518-3614-0) 30 tablet2023-01-090000-00-00NoNoCurrent
70518-3614-17051836140190 TABLET in 1 BOTTLE, PLASTIC (70518-3614-1) 90 tablet2023-08-31NoNoHistorical
70518-3614-27051836140230 TABLET in 1 BOTTLE, PLASTIC (70518-3614-2) 30 tablet2023-09-27NoNoHistorical