pentoxifylline

Generic: pentoxifylline

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pentoxifylline
Generic Name pentoxifylline
Labeler major pharmaceuticals
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

pentoxifylline 400 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-5448
Product ID 0904-5448_e41391a6-e956-41ab-8169-45f6e48d4fa2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075191
Listing Expiration 2026-12-31
Marketing Start 1999-06-10

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 09045448
Hyphenated Format 0904-5448

Supplemental Identifiers

RxCUI
312301
UNII
SD6QCT3TSU
NUI
N0000175895 N0000009065

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 ANDA075191 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (0904-5448-61) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (1)

0904-5448-61 100 BLISTER PACK in 1 CARTON (0904-5448-61) / 1 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": "e41391a6-e956-41ab-8169-45f6e48d4fa2", "openfda": {"nui": ["N0000175895", "N0000009065"], "unii": ["SD6QCT3TSU"], "rxcui": ["312301"], "spl_set_id": ["59c9a583-1f93-480f-879c-457a574374da"], "pharm_class_pe": ["Hematologic Activity Alteration [PE]"], "pharm_class_epc": ["Blood Viscosity Reducer [EPC]"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0904-5448-61)  / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "0904-5448-61", "marketing_start_date": "19990610"}], "brand_name": "PENTOXIFYLLINE", "product_id": "0904-5448_e41391a6-e956-41ab-8169-45f6e48d4fa2", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Blood Viscosity Reducer [EPC]", "Hematologic Activity Alteration [PE]"], "product_ndc": "0904-5448", "generic_name": "PENTOXIFYLLINE", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PENTOXIFYLLINE", "active_ingredients": [{"name": "PENTOXIFYLLINE", "strength": "400 mg/1"}], "application_number": "ANDA075191", "marketing_category": "ANDA", "marketing_start_date": "19990610", "listing_expiration_date": "20261231"}