FDA.reportPublic FDA data

BACLOFEN

Product NDC
70518-3467
11-digit product format
705183467
Labeler code
70518
Product ID
70518-3467_4f1a5c79-6a6e-cf1d-e063-6294a90a18f7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BACLOFEN
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA214099
Marketing category
ANDA
Marketing start
2022-08-05
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
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
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
70518-3467-0BACLOFEN30 in 1 BOTTLE, PLASTICTABLET307
70518-3467-1BACLOFEN30 in 1 BLISTER PACKTABLET307
70518-3467-2BACLOFEN90 in 1 BOTTLE, PLASTICTABLET907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-3467-2EA - Each70518-3467af56aace-b006-4b47-8f9b-dc11b10266c812026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3467BACLOFEN TABLET [REMEDYREPACK INC.]4Current NDC, Legacy NDC, 3 package rows20240113_355266e4-68f7-47d7-9f4e-1a0fc912786d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197392baclofen 20 MG Oral TabletPSN355266e4-68f7-47d7-9f4e-1a0fc912786d7
197392baclofen 20 MG Oral TabletSCD355266e4-68f7-47d7-9f4e-1a0fc912786d7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3467-07051834670030 TABLET in 1 BOTTLE, PLASTIC (70518-3467-0) 30 tablet2022-08-050000-00-00NoNoCurrent
70518-3467-17051834670130 TABLET in 1 BLISTER PACK (70518-3467-1) 30 tablet2022-08-110000-00-00NoNoCurrent
70518-3467-27051834670290 TABLET in 1 BOTTLE, PLASTIC (70518-3467-2) 90 tablet2022-09-280000-00-00NoNoCurrent