FDA.reportPublic FDA data

PENTOXIFYLLINE

Product NDC
72189-025
11-digit product format
721890025
Labeler code
72189
Product ID
72189-025_8f238969-08bc-9464-e053-2995a90abda3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PENTOXIFYLLINE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Direct_Rx
Application
ANDA075191
Marketing category
ANDA
Marketing start
2019-08-02
Marketing end
0000-00-00
Substance
PENTOXIFYLLINE
Active strength
400 mg/1
Pharmacologic classes
Blood Viscosity Reducer [EPC],Hematologic Activity Alteration [PE]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
06331747-0b00-4cea-707f-3d3bfb5d208dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72189-025-302023-01-30C16284748780-1f386c649-f537-0266-e053-dadaa90a7c1aPENTOXIFYLLINE
72189-025-602023-01-30C16284748780-1f386c649-b13a-0266-e053-dadaa90a7c1aPENTOXIFYLLINE
72189-025-902023-01-30C16284748780-1f386c64a-3bb7-0266-e053-dadaa90a7c1aPENTOXIFYLLINE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-025-30PENTOXIFYLLINE30 in 1 BOTTLETABLET, EXTENDED RELEASE301
72189-025-60PENTOXIFYLLINE60 in 1 BOTTLETABLET, EXTENDED RELEASE601
72189-025-90PENTOXIFYLLINE90 in 1 BOTTLETABLET, EXTENDED RELEASE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-025-30EA - Each72189-02589ff2b2d-1b68-4f0f-8da9-274ae6822d0712019-09-05
72189-025-60EA - Each72189-0258a2b3224-ebf0-4b2e-a1be-0699945388d412019-09-05
72189-025-90EA - Each72189-025c3170dd4-cab5-4274-a61c-8f5345ca68c212019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-025PENTOXIFYLLINE TABLET, EXTENDED RELEASE [DIRECT_RX]1Legacy NDC, 1 package rows20190803_8f238969-08bb-9464-e053-2995a90abda3.zip
72189-025PENTOXIFYLLINE TABLET, EXTENDED RELEASE [DIRECT_RX]1Legacy NDC, 1 package rows20190803_8f247ffa-6df9-36f2-e053-2a95a90a346e.zip
72189-025PENTOXIFYLLINE TABLET, EXTENDED RELEASE [DIRECT_RX]1Legacy NDC, 1 package rows20190803_8f24268f-c214-aef0-e053-2995a90a2d62.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312301pentoxifylline 400 MG Extended Release Oral TabletPSN8f238969-08bb-9464-e053-2995a90abda31
312301pentoxifylline 400 MG Extended Release Oral TabletPSN8f24268f-c214-aef0-e053-2995a90a2d621
312301pentoxifylline 400 MG Extended Release Oral TabletPSN8f247ffa-6df9-36f2-e053-2a95a90a346e1
312301pentoxifylline 400 MG Extended Release Oral TabletSCD8f238969-08bb-9464-e053-2995a90abda31
312301pentoxifylline 400 MG Extended Release Oral TabletSCD8f24268f-c214-aef0-e053-2995a90a2d621
312301pentoxifylline 400 MG Extended Release Oral TabletSCD8f247ffa-6df9-36f2-e053-2a95a90a346e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72189-025-307218900253030 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-025-30) 2019-08-020000-00-00NoNoCurrent
72189-025-607218900256060 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-025-60) 2019-08-020000-00-00NoNoCurrent
72189-025-907218900259090 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-025-90) 2019-08-020000-00-00NoNoCurrent