Prescription drug · NDA AUTHORIZED GENERIC
amiloride hydrochloride NDC 0574-0292
Amiloride hydrochloride 5 mg/1 · Tablet · Oral · Padagis US LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0574-0292-01 | 00574029201 | 100 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
N400574029201followed by a unit qualifier and the quantityPackage 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.
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.
Related NDCs: other amiloride hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Amiloride Hydrochloride | Amiloride hydrochloride anhydrous 5 mg/1 | TabletOral | Sigmapharm Laboratories, LLC | 42794-005 | 42794-0005-02 |
| Amiloride Hydrochloride | Amiloride hydrochloride anhydrous 5 mg/1 | TabletOral | Par Health USA, LLC | 49884-117 | 49884-0117-0149884-0117-10 |