FDA.reportPublic FDA data

Pentoxifylline

Product NDC
70954-668
11-digit product format
709540668
Labeler code
70954
Product ID
70954-668_9732cf08-dad4-42a4-a10e-0284848724d7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pentoxifylline
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
ANDA074878
Marketing category
ANDA
Marketing start
2024-01-15
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
70954-668-10Pentoxifylline100 in 1 BOTTLETABLET, EXTENDED RELEASE1003
70954-668-20Pentoxifylline500 in 1 BOTTLETABLET, EXTENDED RELEASE5003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70954-668-10EA - Each70954-6687759ce52-a58b-4f3c-8e1d-a05fd9d148f012024-02-14
70954-668-20EA - Each70954-6681768371f-ade8-4b6b-8fc9-b828b5288d9212024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70954-668PENTOXIFYLLINE TABLET, EXTENDED RELEASE [ANI PHARMACEUTICALS, INC.]2Current NDC, 2 package rows20240119_9ca79c97-e4e5-4297-85eb-7a9b3d8083b5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312301pentoxifylline 400 MG Extended Release Oral TabletPSN9ca79c97-e4e5-4297-85eb-7a9b3d8083b53
312301pentoxifylline 400 MG Extended Release Oral TabletSCD9ca79c97-e4e5-4297-85eb-7a9b3d8083b53
312301pentoxifylline 400 MG Extended Release Oral TabletPSNbd2f2672-62cd-4e77-8b0b-782f5d06198b2
312301pentoxifylline 400 MG Extended Release Oral TabletSCDbd2f2672-62cd-4e77-8b0b-782f5d06198b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70954-668-1070954066810100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70954-668-10) 2024-01-15NoNoHistorical
70954-668-2070954066820500 TABLET, EXTENDED RELEASE in 1 BOTTLE (70954-668-20) 2024-01-15NoNoHistorical