Prescription drug · ANDA

Warfarin Sodium (Warfarin) NDC 68788-8402

Warfarin sodium 2.5 mg/1 · Tablet · Oral · Preferred Pharmaceuticals Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)68788-8402Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68788-8402Add 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
68788-8402-16878884020168788840201100 TABLET in 1 BOTTLE (68788-8402-1)Marketed from Mar 21, 2023
68788-8402-3687888402036878884020330 TABLET in 1 BOTTLE (68788-8402-3)Marketed from Mar 21, 2023
68788-8402-6687888402066878884020660 TABLET in 1 BOTTLE (68788-8402-6)Marketed from Mar 21, 2023
68788-8402-9687888402096878884020990 TABLET in 1 BOTTLE (68788-8402-9)Marketed from Mar 21, 2023

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 2.5 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Preferred Pharmaceuticals Inc.NDC labeler code 68788
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 68788-8402_3687ceaf-725c-4aea-9708-af212aacf43eSPL ID 3687ceaf-725c-4aea-9708-af212aacf43eSPL set ID ac117f50-8e67-4203-8d97-e53dd0687c20RxCUI 855312UNII 6153CWM0CL
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

N468788840201 followed by a unit qualifier and the quantity

Package 68788-8402-01. 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 . 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 cl…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68788-8402

What is NDC 68788-8402?
68788-8402 is the product NDC for Warfarin Sodium (warfarin), Warfarin sodium 2.5 mg/1 tablet, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Warfarin Sodium (Warfarin).
What is the active ingredient?
Warfarin sodium.
Who is the labeler?
Preferred Pharmaceuticals Inc., NDC labeler code 68788. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Warfarin Sodium?
138 other product NDCs are listed under this name. See all Warfarin Sodium 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 Warfarin Sodium NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Warfarin SodiumwarfarinWarfarin sodium 2.5 mg/1TabletOralCoupler LLC67046-114567046-1145-03
Warfarin SodiumwarfarinWarfarin sodium 3 mg/1TabletOralCoupler LLC67046-118567046-1185-03
Warfarin SodiumWarfarin sodium 3 mg/1TabletOralREMEDYREPACK INC.70518-472270518-4722-00
Warfarin SodiumwarfarinWarfarin sodium 10 mg/1TabletOralREMEDYREPACK INC.70518-468470518-4684-00
Warfarin SodiumwarfarinWarfarin sodium 1 mg/1TabletOralCoupler LLC67046-207267046-2072-03
Warfarin SodiumwarfarinWarfarin sodium 2 mg/1TabletOralCoupler LLC67046-106767046-1067-03
Warfarin SodiumWarfarin sodium 2.5 mg/1TabletOralREMEDYREPACK INC.70518-463470518-4634-00
Warfarin SodiumWarfarin sodium 7.5 mg/1TabletOralREMEDYREPACK INC.70518-463570518-4635-00
Warfarin SodiumWarfarin sodium 10 mg/1TabletOralREMEDYREPACK INC.70518-463670518-4636-00
Warfarin SodiumWarfarin sodium 1 mg/1TabletOralREMEDYREPACK INC.70518-463770518-4637-00

All 139 Warfarin Sodium NDCs

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 7.5 mg/1TabletOralA-S Medication Solutions50090-2582
Warfarin SodiumwarfarinWarfarin sodium 2.5 mg/1TabletOralA-S Medication Solutions50090-2586
Warfarin SodiumwarfarinWarfarin sodium 3 mg/1TabletOralA-S Medication Solutions50090-2613
Warfarin SodiumwarfarinWarfarin sodium 6 mg/1TabletOralA-S Medication Solutions50090-2617
Warfarin SodiumwarfarinWarfarin sodium 4 mg/1TabletOralA-S Medication Solutions50090-2645
Warfarin SodiumwarfarinWarfarin sodium 1 mg/1TabletOralA-S Medication Solutions50090-2646
Warfarin SodiumwarfarinWarfarin sodium 5 mg/1TabletOralA-S Medication Solutions50090-2936
Warfarin SodiumwarfarinWarfarin sodium 1 mg/1TabletOralAmneal Pharmaceuticals LLC65162-761
Warfarin SodiumwarfarinWarfarin sodium 2 mg/1TabletOralAmneal Pharmaceuticals LLC65162-762
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 5 mg/1TabletOralAmneal Pharmaceuticals LLC65162-766
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 2 mg/1TabletOralCoupler LLC67046-1067
Warfarin SodiumwarfarinWarfarin sodium 2.5 mg/1TabletOralCoupler LLC67046-1145
Warfarin SodiumwarfarinWarfarin sodium 3 mg/1TabletOralCoupler LLC67046-1185
Warfarin SodiumwarfarinWarfarin sodium 4 mg/1TabletOralCoupler LLC67046-1463

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