pentoxifylline

Generic: pentoxifylline

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pentoxifylline
Generic Name pentoxifylline
Labeler rising pharma holdings, inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

pentoxifylline 400 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 16571-856
Product ID 16571-856_06c53ec5-f3d9-47e2-943e-631ed695adcc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074425
Listing Expiration 2026-12-31
Marketing Start 2024-06-11

Pharmacologic Class

Established (EPC)
blood viscosity reducer [epc]
Physiologic Effect
hematologic activity alteration [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16571856
Hyphenated Format 16571-856

Supplemental Identifiers

RxCUI
312301
UPC
0316571856503
UNII
SD6QCT3TSU
NUI
N0000175895 N0000009065

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name pentoxifylline (source: ndc)
Generic Name pentoxifylline (source: ndc)
Application Number ANDA074425 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (16571-856-01)
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (16571-856-50)
  • 1 BLISTER PACK in 1 CARTON (16571-856-90) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (3)

16571-856-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (16571-856-01) 16571-856-50 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (16571-856-50) 16571-856-90 1 BLISTER PACK in 1 CARTON (16571-856-90) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (1)

pentoxifylline (400 mg/1)

Linked Drug Pages (1)

Pentoxifylline ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "06c53ec5-f3d9-47e2-943e-631ed695adcc", "openfda": {"nui": ["N0000175895", "N0000009065"], "upc": ["0316571856503"], "unii": ["SD6QCT3TSU"], "rxcui": ["312301"], "spl_set_id": ["cd840a2c-2a0e-4b2b-84ff-a0406bb6fa37"], "pharm_class_pe": ["Hematologic Activity Alteration [PE]"], "pharm_class_epc": ["Blood Viscosity Reducer [EPC]"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (16571-856-01)", "package_ndc": "16571-856-01", "marketing_start_date": "20240611"}, {"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (16571-856-50)", "package_ndc": "16571-856-50", "marketing_start_date": "20240611"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (16571-856-90)  / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "16571-856-90", "marketing_start_date": "20240611"}], "brand_name": "Pentoxifylline", "product_id": "16571-856_06c53ec5-f3d9-47e2-943e-631ed695adcc", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Blood Viscosity Reducer [EPC]", "Hematologic Activity Alteration [PE]"], "product_ndc": "16571-856", "generic_name": "Pentoxifylline", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pentoxifylline", "active_ingredients": [{"name": "PENTOXIFYLLINE", "strength": "400 mg/1"}], "application_number": "ANDA074425", "marketing_category": "ANDA", "marketing_start_date": "20240611", "listing_expiration_date": "20261231"}