FDA.reportPublic FDA data

PENTOXIFYLLINE

Product NDC
60505-0033
11-digit product format
605050033
Labeler code
60505
Product ID
60505-0033_e67bdb49-8c37-8b4f-c982-67d024d3f2aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PENTOXIFYLLINE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA075191
Marketing category
ANDA
Marketing start
1999-06-10
Substance
PENTOXIFYLLINE
Active strength
400 mg/1
Pharmacologic classes
Blood Viscosity Reducer [EPC], Hematologic Activity Alteration [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PENTOXIFYLLINE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PENTOXIFYLLINE400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSD6QCT3TSU
Rxcui312301

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
60505-0033-62025-08-21C16284748780-13b156c62-2e1c-fb37-e063-e6dba90a4e07PENTOXIFYLLINE EXTENDED-RELEASE TABLETS, USP 400 mg Rx Only
60505-0033-72025-08-21C16284748780-13b156c62-2e1c-fb37-e063-e6dba90a4e07PENTOXIFYLLINE EXTENDED-RELEASE TABLETS, USP 400 mg Rx Only
60505-0033-82025-08-21C16284748780-13b156c62-2e1c-fb37-e063-e6dba90a4e07PENTOXIFYLLINE EXTENDED-RELEASE TABLETS, USP 400 mg Rx Only
60505-0033-92025-08-21C16284748780-13b156c62-2e1c-fb37-e063-e6dba90a4e07PENTOXIFYLLINE EXTENDED-RELEASE TABLETS, USP 400 mg Rx Only
60505-0033-62025-07-29C16284748780-13b156c62-2e1c-fb37-e063-e6dba90a4e07PENTOXIFYLLINE EXTENDED-RELEASE TABLETS, USP 400 mg Rx Only
60505-0033-72025-07-29C16284748780-13b156c62-2e1c-fb37-e063-e6dba90a4e07PENTOXIFYLLINE EXTENDED-RELEASE TABLETS, USP 400 mg Rx Only
60505-0033-82025-07-29C16284748780-13b156c62-2e1c-fb37-e063-e6dba90a4e07PENTOXIFYLLINE EXTENDED-RELEASE TABLETS, USP 400 mg Rx Only
60505-0033-92025-07-29C16284748780-13b156c62-2e1c-fb37-e063-e6dba90a4e07PENTOXIFYLLINE EXTENDED-RELEASE TABLETS, USP 400 mg Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60505-0033-6PENTOXIFYLLINE100 in 1 BOTTLETABLET, EXTENDED RELEASE10014
60505-0033-7PENTOXIFYLLINE500 in 1 BOTTLETABLET, EXTENDED RELEASE50014
60505-0033-8PENTOXIFYLLINE5500 in 1 BOTTLETABLET, EXTENDED RELEASE550014
60505-0033-9PENTOXIFYLLINE1000 in 1 BOTTLETABLET, EXTENDED RELEASE100014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-0033-6EA - Each60505-00333fda10a6-d092-4023-a8c9-69b4af92f5e012012-07-24
60505-0033-7EA - Each60505-0033c9dcfae7-d39d-42d5-861c-19ac776564e112012-07-24
60505-0033-8EA - Each60505-00330f9eb6dc-8171-4b3b-9851-b27c36d997b812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PENTOXIFYLLINEACTIVE INGREDIENTSD6QCT3TSUPENTOXIFYLLINE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
PENTOXIFYLLINEACTIVE MOIETYSD6QCT3TSUPENTOXIFYLLINE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PPENTOXIFYLLINE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPENTOXIFYLLINE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PENTOXIFYLLINE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BPENTOXIFYLLINE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PENTOXIFYLLINE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPENTOXIFYLLINE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
PentoxifyllineACTIVE INGREDIENTSD6QCT3TSUPENTOXIFYLLINE TABLET, EXTENDED RELEASE [APOTEX CORP.]5
PENTOXIFYLLINEACTIVE MOIETYSD6QCT3TSUPENTOXIFYLLINE TABLET, EXTENDED RELEASE [APOTEX CORP.]5
Hydroxypropyl Cellulose (Type H)INACTIVE INGREDIENTRFW2ET671PPENTOXIFYLLINE TABLET, EXTENDED RELEASE [APOTEX CORP.]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPENTOXIFYLLINE TABLET, EXTENDED RELEASE [APOTEX CORP.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PENTOXIFYLLINE TABLET, EXTENDED RELEASE [APOTEX CORP.]5
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BPENTOXIFYLLINE TABLET, EXTENDED RELEASE [APOTEX CORP.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PENTOXIFYLLINE TABLET, EXTENDED RELEASE [APOTEX CORP.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPENTOXIFYLLINE TABLET, EXTENDED RELEASE [APOTEX CORP.]5
PENTOXIFYLLINEACTIVE INGREDIENTSD6QCT3TSUPENTOXIFYLLINE TABLET, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
PENTOXIFYLLINEACTIVE INGREDIENTSD6QCT3TSUPENTOXIFYLLINE TABLET, FILM COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
PENTOXIFYLLINEACTIVE INGREDIENTSD6QCT3TSUPENTOXIFYLLINE TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
PENTOXIFYLLINEACTIVE INGREDIENTSD6QCT3TSUPENTOXIFYLLINE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]1
PENTOXIFYLLINEACTIVE MOIETYSD6QCT3TSUPENTOXIFYLLINE TABLET, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
PENTOXIFYLLINEACTIVE MOIETYSD6QCT3TSUPENTOXIFYLLINE TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
PENTOXIFYLLINEACTIVE MOIETYSD6QCT3TSUPENTOXIFYLLINE TABLET, FILM COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
PENTOXIFYLLINEACTIVE MOIETYSD6QCT3TSUPENTOXIFYLLINE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]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
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PPENTOXIFYLLINE TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PPENTOXIFYLLINE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PPENTOXIFYLLINE TABLET, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOPENTOXIFYLLINE TABLET, FILM COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPENTOXIFYLLINE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPENTOXIFYLLINE TABLET, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPENTOXIFYLLINE TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PENTOXIFYLLINE TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PENTOXIFYLLINE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PENTOXIFYLLINE TABLET, FILM COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PENTOXIFYLLINE TABLET, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]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
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BPENTOXIFYLLINE TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BPENTOXIFYLLINE TABLET, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BPENTOXIFYLLINE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EPENTOXIFYLLINE TABLET, FILM COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PENTOXIFYLLINE TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PENTOXIFYLLINE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PENTOXIFYLLINE TABLET, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPENTOXIFYLLINE TABLET, FILM COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPENTOXIFYLLINE TABLET, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPENTOXIFYLLINE TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPENTOXIFYLLINE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]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
60505-0033PENTOXIFYLLINE TABLET, EXTENDED RELEASE [APOTEX CORP.]13Current NDC, Legacy NDC, 4 package rows20241105_40ae2d9a-0d95-640d-0640-f76e7e1a13cb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312301pentoxifylline 400 MG Extended Release Oral TabletPSN84816505-9253-41cf-8894-2b2d0e4aff671012
312301pentoxifylline 400 MG Extended Release Oral TabletSCD84816505-9253-41cf-8894-2b2d0e4aff671012
312301pentoxifylline 400 MG Extended Release Oral TabletPSN40ae2d9a-0d95-640d-0640-f76e7e1a13cb14
312301pentoxifylline 400 MG Extended Release Oral TabletSCD40ae2d9a-0d95-640d-0640-f76e7e1a13cb14
312301pentoxifylline 400 MG Extended Release Oral TabletPSN59c9a583-1f93-480f-879c-457a574374da6
312301pentoxifylline 400 MG Extended Release Oral TabletSCD59c9a583-1f93-480f-879c-457a574374da6
312301pentoxifylline 400 MG Extended Release Oral TabletPSNe09702d1-43d4-47ed-9563-5af3cd6677271
312301pentoxifylline 400 MG Extended Release Oral TabletPSNa6c39757-4551-4493-b27f-5b311fd1fc771
312301pentoxifylline 400 MG Extended Release Oral TabletPSN8f247ffa-6df9-36f2-e053-2a95a90a346e1
312301pentoxifylline 400 MG Extended Release Oral TabletPSN8f24268f-c214-aef0-e053-2995a90a2d621
312301pentoxifylline 400 MG Extended Release Oral TabletPSN8f238969-08bb-9464-e053-2995a90abda31
312301pentoxifylline 400 MG Extended Release Oral TabletPSN73a76a95-ada5-4707-ab89-fd60e8eda64e1
312301pentoxifylline 400 MG Extended Release Oral TabletSCD8f24268f-c214-aef0-e053-2995a90a2d621
312301pentoxifylline 400 MG Extended Release Oral TabletSCD8f238969-08bb-9464-e053-2995a90abda31
312301pentoxifylline 400 MG Extended Release Oral TabletSCD8f247ffa-6df9-36f2-e053-2a95a90a346e1
312301pentoxifylline 400 MG Extended Release Oral TabletSCDa6c39757-4551-4493-b27f-5b311fd1fc771
312301pentoxifylline 400 MG Extended Release Oral TabletSCDe09702d1-43d4-47ed-9563-5af3cd6677271
312301pentoxifylline 400 MG Extended Release Oral TabletSCD73a76a95-ada5-4707-ab89-fd60e8eda64e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60505-0033-660505003306100 TABLET, EXTENDED RELEASE in 1 BOTTLE (60505-0033-6) 1999-06-100000-00-00NoNoCurrent
60505-0033-760505003307500 TABLET, EXTENDED RELEASE in 1 BOTTLE (60505-0033-7) 1999-06-100000-00-00NoNoCurrent
60505-0033-8605050033085500 TABLET, EXTENDED RELEASE in 1 BOTTLE (60505-0033-8) 1999-06-100000-00-00NoNoCurrent
60505-0033-9605050033091000 TABLET, EXTENDED RELEASE in 1 BOTTLE (60505-0033-9) 1999-06-100000-00-00NoNoCurrent