NDC codes

FDA NDC Directory
Product NDC (as listed)43353-315Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43353-0315Add 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
43353-315-1643353031516433530315166000 TABLET in 1 BOTTLE, PLASTIC (43353-315-16)Marketed from May 3, 2017

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)
Torsemide
Generic name (nonproprietary)
torsemide
Active ingredients
Torsemide — 20 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 43353
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 076943
Marketing start
Listing expires
Other FDA classes
Increased Diuresis at Loop of Henle (Physiologic effect)
Identifiers
Product ID 43353-315_cd00a5cc-04b6-49cd-89d0-ae552b415f5dSPL ID cd00a5cc-04b6-49cd-89d0-ae552b415f5dSPL set ID b869bc45-1ebb-42fb-82c5-603f09835790RxCUI 198371UNII W31X2H97FB
Pharmacologic class
Loop Diuretic

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

N443353031516 followed by a unit qualifier and the quantity

Package 43353-0315-16. 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)

Torsemide is a loop diuretic indicated for: • the treatment of edema associated with heart failure, renal disease or hepatic disease. ( 1.1 ) • the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.2 ) 1.1 Edema Torsemide is indicated for the treatment of edema associated with heart failure, renal disease, or hepatic disease. 1.2 Hypertension Torsemide is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. Th…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 43353-315

What is NDC 43353-315?
43353-315 is the product NDC for Torsemide, Torsemide 20 mg/1 tablet, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Torsemide.
What is the active ingredient?
Torsemide.
Who is the labeler?
Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 43353. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Torsemide?
60 other product NDCs are listed under this name. See all Torsemide 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 Torsemide NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
TorsemideTorsemide 5 mg/1TabletOralXLCare Pharmaceuticals Inc.72865-25872865-0258-90
TorsemideTorsemide 10 mg/1TabletOralXLCare Pharmaceuticals Inc.72865-25972865-0259-0172865-0259-90
TorsemideTorsemide 20 mg/1TabletOralXLCare Pharmaceuticals Inc.72865-26072865-0260-0172865-0260-0572865-0260-90
TorsemideTorsemide 100 mg/1TabletOralXLCare Pharmaceuticals Inc.72865-26172865-0261-0172865-0261-90
TorsemideTorsemide 20 mg/1TabletOralREMEDYREPACK INC.70518-413970518-4139-00
TorsemideTorsemide 5 mg/1TabletOralHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.23155-87123155-0871-0123155-0871-0523155-0871-10
TorsemideTorsemide 10 mg/1TabletOralHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.23155-87223155-0872-0123155-0872-0523155-0872-10
TorsemideTorsemide 20 mg/1TabletOralHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.23155-87323155-0873-0123155-0873-0523155-0873-10
TorsemideTorsemide 100 mg/1TabletOralHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.23155-87423155-0874-0123155-0874-0523155-0874-10
TorsemideTorsemide 20 mg/1TabletOralBryant Ranch Prepack71335-266371335-2663-0171335-2663-02

All 61 Torsemide NDCs

Other NDCs under ANDA 076943

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

FDA NDC Directory listings under ANDA 076943
ProductStrengthForm · routeLabelerProduct NDC
TorsemideTorsemide 20 mg/1TabletOralHikma Pharmaceuticals USA Inc.0054-0077
TorsemideTorsemide 20 mg/1TabletOralGolden State Medical Supply, Inc.51407-362
TorsemideTorsemide 20 mg/1TabletOralREMEDYREPACK INC.70518-2195
TorsemideTorsemide 20 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-819

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