Prescription drug · ANDA

Warfarin Sodium (warfarin) NDC 65162-761

Warfarin sodium 1 mg/1 · Tablet · Oral · Amneal Pharmaceuticals LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)65162-761Labeler and product segments. Claims need a package NDC.
Product NDC at billing width65162-0761Add 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
65162-761-1065162076110100 TABLET in 1 BOTTLE (65162-761-10)Marketed from Aug 16, 2010
65162-761-11651620761111000 TABLET in 1 BOTTLE (65162-761-11)Marketed from Aug 16, 2010
65162-761-5065162076150500 TABLET in 1 BOTTLE (65162-761-50)Marketed from Aug 16, 2010

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)
Warfarin Sodium
Generic name (nonproprietary)
warfarin
Active ingredients
Warfarin sodium — 1 mg/1
Dosage form
Tablet
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 202202
Marketing start
Listing expires
Other FDA classes
Vitamin K Inhibitors (Mechanism)
Identifiers
Product ID 65162-761_caa13d7d-5a78-412c-8e5e-e03a51164e96SPL ID caa13d7d-5a78-412c-8e5e-e03a51164e96SPL set ID 558b7a0d-5490-4c1b-802e-3ab3f1efe760RxCUI 855288, 855296, 855302, 855312, 855318, 855324, 855332, 855338, 855344UNII 6153CWM0CLUPC 0365162764109, 0365162769104, 0365162762105, 0365162767100, 0365162763102, 0365162765106
Pharmacologic class
Vitamin K Antagonist

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

N465162076110 followed by a unit qualifier and the quantity

Package 65162-0761-10. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

Warfarin sodium tablets are indicated for: Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE). Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement. Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction. Limitations of Use Warfarin sodium tablets have no direct effect on an established thrombus, nor does it reverse ischemic tissue damage. Once a thrombus has occurred, however, the goals of anticoagulant treatment are to prevent further extension of the formed clot and…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 202202

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

FDA NDC Directory listings under ANDA 202202
ProductStrengthForm · routeLabelerProduct NDC
Warfarin SodiumwarfarinWarfarin sodium 2.5 mg/1TabletOralBryant Ranch Prepack71335-1824
Warfarin SodiumwarfarinWarfarin sodium 4 mg/1TabletOralCoupler LLC67046-1463
Warfarin SodiumwarfarinWarfarin sodium 1 mg/1TabletOralCoupler LLC67046-2072
Warfarin SodiumwarfarinWarfarin sodium 3 mg/1TabletOralBryant Ranch Prepack71335-1786
Warfarin SodiumWarfarin sodium 4 mg/1TabletOralDirect_Rx72189-405
Warfarin SodiumwarfarinWarfarin sodium 7.5 mg/1TabletOralCoupler LLC67046-1525
Warfarin SodiumwarfarinWarfarin sodium 2 mg/1TabletOralAmneal Pharmaceuticals LLC65162-762
Warfarin SodiumwarfarinWarfarin sodium 5 mg/1TabletOralAmneal Pharmaceuticals LLC65162-766
Warfarin SodiumwarfarinWarfarin sodium 2.5 mg/1TabletOralAmneal Pharmaceuticals LLC65162-763
Warfarin SodiumwarfarinWarfarin sodium 3 mg/1TabletOralAmneal Pharmaceuticals LLC65162-764
Warfarin SodiumwarfarinWarfarin sodium 4 mg/1TabletOralAmneal Pharmaceuticals LLC65162-765
Warfarin SodiumwarfarinWarfarin sodium 6 mg/1TabletOralAmneal Pharmaceuticals LLC65162-767
Warfarin SodiumwarfarinWarfarin sodium 7.5 mg/1TabletOralAmneal Pharmaceuticals LLC65162-768
Warfarin SodiumwarfarinWarfarin sodium 10 mg/1TabletOralAmneal Pharmaceuticals LLC65162-769
Warfarin SodiumwarfarinWarfarin sodium 3 mg/1TabletOralREMEDYREPACK INC.70518-2380
Warfarin SodiumwarfarinWarfarin sodium 2 mg/1TabletOralREMEDYREPACK INC.70518-2381
Warfarin SodiumwarfarinWarfarin sodium 5 mg/1TabletOralREMEDYREPACK INC.70518-2382
Warfarin SodiumwarfarinWarfarin sodium 1 mg/1TabletOralREMEDYREPACK INC.70518-2383
Warfarin SodiumwarfarinWarfarin sodium 6 mg/1TabletOralREMEDYREPACK INC.70518-2394
Warfarin SodiumwarfarinWarfarin sodium 4 mg/1TabletOralREMEDYREPACK INC.70518-2395

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Warfarin Sodium (warfarin) NDC 65162-761 | Med-Code