FDA.reportPublic FDA data

PENTOXIFYLLINE

Product NDC
63629-2910
11-digit product format
636292910
Labeler code
63629
Product ID
63629-2910_8512c162-5ecc-4d0d-a3fa-ebf950299c1c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PENTOXIFYLLINE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-2910-1PENTOXIFYLLINE30 in 1 BOTTLETABLET, EXTENDED RELEASE301012
63629-2910-2PENTOXIFYLLINE60 in 1 BOTTLETABLET, EXTENDED RELEASE601012
63629-2910-3PENTOXIFYLLINE90 in 1 BOTTLETABLET, EXTENDED RELEASE901012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2910-1EA - Each63629-29102ee7ffea-db46-448f-b925-1d9c8421e09212013-02-13
63629-2910-2EA - Each63629-291014095e7e-296f-4303-a257-ee96023379ab12013-02-13

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2910PENTOXIFYLLINE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1011Current NDC, Legacy NDC, 3 package rows20241220_84816505-9253-41cf-8894-2b2d0e4aff67.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-2910-16362929100130 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-2910-1) 2005-08-090000-00-00NoNoCurrent
63629-2910-26362929100260 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-2910-2) 2024-12-060000-00-00NoNoCurrent
63629-2910-36362929100390 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-2910-3) 2023-10-110000-00-00NoNoCurrent