BACLOFEN

Product NDC
17856-0319
11-digit product format
178560319
Labeler code
17856
Product ID
17856-0319_ef25a8cc-ed04-4b0b-8e88-5bf746761136
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BACLOFEN
Dosage form
TABLET
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
ANDA209102
Marketing category
ANDA
Marketing start
2018-04-01
Marketing end
0000-00-00
Substance
BACLOFEN
Active strength
5 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
2022-12-31
Current FDA listing
Historical FDA.report record

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
17856-0319-12023-01-30C16284748780-1f386c649-c4fa-0266-e053-dadaa90a7c1aBACLOFEN TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0319-1BACLOFEN100 in 1 BOX, UNIT-DOSETABLET1001
17856-0319-1BACLOFEN1 in 1 POUCHTABLET11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0319BACLOFEN TABLET [ATLANTIC BIOLOGICALS CORP.]1Legacy NDC, 2 package rows20210514_9760d274-fe1c-49a4-bc68-eff8142b75ec.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
430902baclofen 5 MG Oral TabletPSN9760d274-fe1c-49a4-bc68-eff8142b75ec1
430902baclofen 5 MG Oral TabletSCD9760d274-fe1c-49a4-bc68-eff8142b75ec1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17856-0319-117856031901100 POUCH in 1 BOX, UNIT-DOSE (17856-0319-1) > 1 TABLET in 1 POUCH100 pouch2021-05-120000-00-00NoNoCurrent