Pentoxifylline

Product NDC
53808-0758
11-digit product format
538080758
Labeler code
53808
Product ID
53808-0758_176f8340-f270-4873-87e5-b53323a2b6ee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pentoxifylline
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA074425
Marketing category
ANDA
Marketing start
2009-07-01
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
E
Listing certified through
2017-12-31
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
53808-0758-12019-10-21C16284748780-1956f9ecf-c1f8-621f-e053-dbdaa90a74ad83d5ef4b-8b46-48b6-ae5a-9a0e493350a0

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0758-1Pentoxifylline30 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PENTOXIFYLLINEACTIVE INGREDIENTSD6QCT3TSUPENTOXIFYLLINE TABLET, FILM COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
PENTOXIFYLLINEACTIVE MOIETYSD6QCT3TSUPENTOXIFYLLINE TABLET, FILM COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPENTOXIFYLLINE TABLET, FILM COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BPENTOXIFYLLINE TABLET, FILM COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKPENTOXIFYLLINE TABLET, FILM COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PENTOXIFYLLINE TABLET, FILM COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)INACTIVE INGREDIENT8136Y38GY5PENTOXIFYLLINE TABLET, FILM COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOPENTOXIFYLLINE TABLET, FILM COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PENTOXIFYLLINE TABLET, FILM COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEPENTOXIFYLLINE TABLET, FILM COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1APENTOXIFYLLINE TABLET, FILM COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EPENTOXIFYLLINE TABLET, FILM COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPENTOXIFYLLINE TABLET, FILM COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TRIACETININACTIVE INGREDIENTXHX3C3X673PENTOXIFYLLINE TABLET, FILM COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0758PENTOXIFYLLINE TABLET, FILM COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20100614_83d5ef4b-8b46-48b6-ae5a-9a0e493350a0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312301pentoxifylline 400 MG Extended Release Oral TabletPSN83d5ef4b-8b46-48b6-ae5a-9a0e493350a01
312301pentoxifylline 400 MG Extended Release Oral TabletSCD83d5ef4b-8b46-48b6-ae5a-9a0e493350a01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0758-15380807580130 in 1 BLISTER PACKHistorical