Prescription drug · ANDA
Pentoxifylline NDC 16571-856
Pentoxifylline 400 mg/1 · Tablet, Extended release · Oral · Rising Pharma Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16571-856-01 | 16571085601 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (16571-856-01)Marketed from Jun 5, 2026 | |
| 16571-856-05 | 16571085605 | 50 BLISTER PACK in 1 CARTON (16571-856-05) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jun 5, 2026 | |
| 16571-856-11 | 16571085611 | 10 BLISTER PACK in 1 CARTON (16571-856-11) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jun 5, 2026 | |
| 16571-856-50 | 16571085650 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (16571-856-50)Marketed from Jun 5, 2026 | |
| 16571-856-90 | 16571085690 | 1 BLISTER PACK in 1 CARTON (16571-856-90) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jun 5, 2026 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Pentoxifylline
- Generic name (nonproprietary)
- pentoxifylline
- Active ingredients
- Pentoxifylline — 400 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Rising Pharma Holdings, Inc.NDC labeler code 16571
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074425
- Marketing start
- Listing expires
- Other FDA classes
- Hematologic Activity Alteration (Physiologic effect)
- Identifiers
- Product ID 16571-856_465e591b-4af7-4b59-a076-73bc26758edaSPL ID 465e591b-4af7-4b59-a076-73bc26758edaSPL set ID cd840a2c-2a0e-4b2b-84ff-a0406bb6fa37RxCUI 312301UNII SD6QCT3TSUUPC 0316571856503
- Pharmacologic class
- Blood Viscosity Reducer
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N416571085601followed by a unit qualifier and the quantityPackage 16571-0856-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS & USAGE Pentoxifylline extended-release tablets are indicated for the treatment of patients with intermittent claudication on the basis of chronic occlusive arterial disease of the limbs. Pentoxifylline extended-release tablets can improve function and symptoms but is not intended to replace more definitive therapy, such as surgical bypass, or removal of arterial obstructions when treating peripheral vascular disease.
Excerpt only. Read the full label for complete information.
About NDC 16571-856
- What is NDC 16571-856?
- 16571-856 is the product NDC for Pentoxifylline, Pentoxifylline 400 mg/1 tablet, extended release, listed with the FDA by Rising Pharma Holdings, Inc.. It has 5 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Pentoxifylline.
- What is the active ingredient?
- Pentoxifylline.
- Who is the labeler?
- Rising Pharma Holdings, Inc., NDC labeler code 16571. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Pentoxifylline?
- 7 other product NDCs are listed under this name. See all Pentoxifylline NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Pentoxifylline products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Pentoxifylline | Pentoxifylline 400 mg/1 | TabletOral | Advagen Pharma Ltd., | 72888-268 | 72888-0268-0172888-0268-0272888-0268-03 |
| Pentoxifylline | Pentoxifylline 400 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-2586 | 71335-2586-0171335-2586-0271335-2586-03 |
| Pentoxifylline | Pentoxifylline 400 mg/1 | Tablet, Extended releaseOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8511 | 00615-8511-39 |
| Pentoxifylline | Pentoxifylline 400 mg/1 | Tablet, Extended releaseOral | ANI Pharmaceuticals, Inc. | 70954-668 | 70954-0668-1070954-0668-20 |
| Pentoxifylline | Pentoxifylline 400 mg/1 | Tablet, Extended releaseOral | Major Pharmaceuticals | 0904-5448 | 00904-5448-61 |
| Pentoxifylline | Pentoxifylline 400 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 63629-2910 | 63629-2910-0163629-2910-0263629-2910-03 |
| Pentoxifylline | Pentoxifylline 400 mg/1 | Tablet, Extended releaseOral | Apotex Corp. | 60505-0033 | 60505-0033-0660505-0033-07 |
Other NDCs under ANDA 074425
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Pentoxifylline | Pentoxifylline 400 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-2586 |