Pentoxifylline

Product NDC
16571-856
11-digit product format
165710856
Labeler code
16571
Product ID
16571-856_06c53ec5-f3d9-47e2-943e-631ed695adcc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pentoxifylline
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA074425
Marketing category
ANDA
Marketing start
2024-06-11
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
16571-856-01Pentoxifylline100 in 1 BOTTLETABLET, EXTENDED RELEASE1003
16571-856-50Pentoxifylline500 in 1 BOTTLETABLET, EXTENDED RELEASE5003
16571-856-90Pentoxifylline10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE103
16571-856-90Pentoxifylline1 in 1 CARTONTABLET, EXTENDED RELEASE13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-856-01EA - Each16571-85661d08ea3-785d-4054-a598-65c771db9ef612024-08-12
16571-856-50EA - Each16571-8564af7d484-43b2-4ca9-a45e-d27d83cd21f912024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-856PENTOXIFYLLINE TABLET, EXTENDED RELEASE [RISING PHARMA HOLDINGS, INC.]3Current NDC, 4 package rows20250426_cd840a2c-2a0e-4b2b-84ff-a0406bb6fa37.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312301pentoxifylline 400 MG Extended Release Oral TabletPSNcd840a2c-2a0e-4b2b-84ff-a0406bb6fa373
312301pentoxifylline 400 MG Extended Release Oral TabletSCDcd840a2c-2a0e-4b2b-84ff-a0406bb6fa373
312301pentoxifylline 400 MG Extended Release Oral TabletPSNc3ad4fb4-8995-46ab-86e9-7ec67ef607f91
312301pentoxifylline 400 MG Extended Release Oral TabletSCDc3ad4fb4-8995-46ab-86e9-7ec67ef607f91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
16571-856-0116571085601100 TABLET, EXTENDED RELEASE in 1 BOTTLE (16571-856-01) 2024-06-11NoNoHistorical
16571-856-5016571085650500 TABLET, EXTENDED RELEASE in 1 BOTTLE (16571-856-50) 2024-06-11NoNoHistorical
16571-856-90165710856901 BLISTER PACK in 1 CARTON (16571-856-90) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2024-06-11NoNoHistorical