NDC codes

FDA NDC Directory
Product NDC (as listed)0904-5448Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00904-5448Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
0904-5448-6100904544861100 BLISTER PACK in 1 CARTON (0904-5448-61) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jun 10, 1999

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
Major PharmaceuticalsNDC labeler code 0904
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 075191
Marketing start
Listing expires
Other FDA classes
Hematologic Activity Alteration (Physiologic effect)
Identifiers
Product ID 0904-5448_e41391a6-e956-41ab-8169-45f6e48d4fa2SPL ID e41391a6-e956-41ab-8169-45f6e48d4fa2SPL set ID 59c9a583-1f93-480f-879c-457a574374daRxCUI 312301UNII SD6QCT3TSU
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

N400904544861 followed by a unit qualifier and the quantity

Package 00904-5448-61. 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 AND 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 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.

Full label on DailyMed (opens in a new tab)

About NDC 0904-5448

What is NDC 0904-5448?
0904-5448 is the product NDC for Pentoxifylline, Pentoxifylline 400 mg/1 tablet, extended release, listed with the FDA by Major Pharmaceuticals. It has 1 package NDC, 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?
Major Pharmaceuticals, NDC labeler code 0904. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Pentoxifylline NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
PentoxifyllinePentoxifylline 400 mg/1TabletOralAdvagen Pharma Ltd.,72888-26872888-0268-0172888-0268-0272888-0268-03
PentoxifyllinePentoxifylline 400 mg/1Tablet, Extended releaseOralBryant Ranch Prepack71335-258671335-2586-0171335-2586-0271335-2586-03
PentoxifyllinePentoxifylline 400 mg/1Tablet, Extended releaseOralRising Pharma Holdings, Inc.16571-85616571-0856-0116571-0856-0516571-0856-11+2 more
PentoxifyllinePentoxifylline 400 mg/1Tablet, Extended releaseOralNCS HealthCare of KY, LLC dba Vangard Labs0615-851100615-8511-39
PentoxifyllinePentoxifylline 400 mg/1Tablet, Extended releaseOralANI Pharmaceuticals, Inc.70954-66870954-0668-1070954-0668-20
PentoxifyllinePentoxifylline 400 mg/1Tablet, Extended releaseOralApotex Corp.60505-003360505-0033-0660505-0033-07
PentoxifyllinePentoxifylline 400 mg/1Tablet, Extended releaseOralBryant Ranch Prepack63629-291063629-2910-0163629-2910-0263629-2910-03

Other NDCs under ANDA 075191

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 075191
ProductStrengthForm · routeLabelerProduct NDC
PentoxifyllinePentoxifylline 400 mg/1Tablet, Extended releaseOralApotex Corp.60505-0033
PentoxifyllinePentoxifylline 400 mg/1Tablet, Extended releaseOralBryant Ranch Prepack63629-2910

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