NDC codes

FDA NDC Directory
Product NDC (as listed)0574-0292Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00574-0292Add 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
0574-0292-0100574029201100 TABLET in 1 BOTTLE (0574-0292-01)Marketed from Apr 6, 2009

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)
amiloride hydrochloride
Generic name (nonproprietary)
amiloride hydrochloride
Active ingredients
Amiloride hydrochloride — 5 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Padagis US LLCNDC labeler code 0574
Product type
Prescription drug
Marketing category
NDA authorized genericApplication NDA 018200
Marketing start
Listing expires
Other FDA classes
Decreased Renal K+ Excretion (Physiologic effect)Increased Diuresis (Physiologic effect)
Identifiers
Product ID 0574-0292_416c3aaf-7390-40cf-995a-31258156b4f2SPL ID 416c3aaf-7390-40cf-995a-31258156b4f2SPL set ID 2b70cf0c-45be-428f-b396-5001ed4e30fcRxCUI 977880UNII FZJ37245UC
Pharmacologic class
Potassium-sparing 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

N400574029201 followed by a unit qualifier and the quantity

Package 00574-0292-01. 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)

INDICATIONS AND USAGE Amiloride HCl is indicated as adjunctive treatment with thiazide diuretics or other kaliuretic-diuretic agents in congestive heart failure or hypertension to: a. help restore normal serum potassium levels in patients who develop hypokalemia on the kaliuretic diuretic b. prevent development of hypokalemia in patients who would be exposed to particular risk if hypokalemia were to develop, e.g., digitalized patients or patients with significant cardiac arrhythmias. The use of potassium-conserving agents is often unnecessary in patients receiving diuretics for uncomplicated essential hypertension when such patients have a normal diet. Amiloride HCl has little additive diure…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0574-0292

What is NDC 0574-0292?
0574-0292 is the product NDC for amiloride hydrochloride, Amiloride hydrochloride 5 mg/1 tablet, listed with the FDA by Padagis US LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
amiloride hydrochloride.
What is the active ingredient?
Amiloride hydrochloride.
Who is the labeler?
Padagis US LLC, NDC labeler code 0574. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for amiloride hydrochloride?
2 other product NDCs are listed under this name. See all amiloride hydrochloride 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 amiloride hydrochloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Amiloride HydrochlorideAmiloride hydrochloride anhydrous 5 mg/1TabletOralSigmapharm Laboratories, LLC42794-00542794-0005-02
Amiloride HydrochlorideAmiloride hydrochloride anhydrous 5 mg/1TabletOralPar Health USA, LLC49884-11749884-0117-0149884-0117-10

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