NDC 0378-0357

Pentoxifylline

Pentoxifylline

Pentoxifylline is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc. The primary component is Pentoxifylline.

• Product ID: 0378-0357_b0efface-fec0-46a1-8735-46dec6290e68
• NDC: 0378-0357
• Product Type: Human Prescription Drug
• Proprietary Name: Pentoxifylline
• Generic Name: Pentoxifylline
• Dosage Form: Tablet, Film Coated, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 1997-07-08
• Marketing End Date: 2019-05-31
• Marketing Category: ANDA / ANDA
• Application Number: ANDA074425
• Labeler Name: Mylan Pharmaceuticals Inc
• Substance Name: PENTOXIFYLLINE
• Active Ingredient Strength: 400 mg/1
• Pharm Classes: Blood Viscosity
• NDC Exclude Flag: N

Packaging

NDC 0378-0357-01

100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0378-0357-01)

• Marketing Start Date: 1997-07-08
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0378-0357-01 [00378035701]

Pentoxifylline TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA074425
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1997-07-08
• Marketing End Date: 2019-05-31

NDC 0378-0357-05 [00378035705]

Pentoxifylline TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA074425
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1997-07-08
• Marketing End Date: 2019-05-31

Drug Details

Active Ingredients

Ingredient	Strength
PENTOXIFYLLINE	400 mg/1

OpenFDA Data

• SPL SET ID: 0ea37402-987c-4964-a810-e8989e0e5358
• Manufacturer:
  • Mylan Pharmaceuticals Inc.
• UNII:
  • SD6QCT3TSU
• RxNorm Concept Unique ID - RxCUI:
  • 312301

Pharmacological Class

• Blood Viscosity Reducer [EPC]
• Hematologic Activity Alteration [PE]

NDC Crossover Matching brand name "Pentoxifylline" or generic name "Pentoxifylline"

NDC	Brand Name	Generic Name
0378-0357	Pentoxifylline	Pentoxifylline
0615-4523	Pentoxifylline	Pentoxifylline
0615-8305	PENTOXIFYLLINE	PENTOXIFYLLINE
0904-5448	PENTOXIFYLLINE	PENTOXIFYLLINE
33261-992	PENTOXIFYLLINE	PENTOXIFYLLINE
43353-123	Pentoxifylline	Pentoxifylline
51079-889	Pentoxifylline	Pentoxifylline
53808-0516	Pentoxifylline	Pentoxifylline
53808-0757	Pentoxifylline	PENTOXIFYLLINE
53808-0758	Pentoxifylline	Pentoxifylline
60429-703	PENTOXIFYLLINE	PENTOXIFYLLINE
60505-0033	PENTOXIFYLLINE	PENTOXIFYLLINE
63629-2910	PENTOXIFYLLINE	PENTOXIFYLLINE
66267-710	PENTOXIFYLLINE	PENTOXIFYLLINE
67544-252	PENTOXIFYLLINE	PENTOXIFYLLINE
68071-4532	Pentoxifylline	Pentoxifylline
68682-101	Pentoxifylline	Pentoxifylline
68788-9742	PENTOXIFYLLINE	PENTOXIFYLLINE
70518-1285	PENTOXIFYLLINE	PENTOXIFYLLINE
72189-025	PENTOXIFYLLINE	PENTOXIFYLLINE