Prescription drug · ANDA
Amiloride Hydrochloride NDC 49884-117
Amiloride hydrochloride anhydrous 5 mg/1 · Tablet · Oral · Par Health USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49884-117-01 | 49884011701 | 100 TABLET in 1 BOTTLE (49884-117-01)Marketed from May 12, 1986 | |
| 49884-117-10 | 49884011710 | 1000 TABLET in 1 BOTTLE (49884-117-10)Marketed from May 12, 1986 |
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)
- Amiloride Hydrochloride
- Generic name (nonproprietary)
- amiloride hydrochloride
- Active ingredients
- Amiloride hydrochloride anhydrous — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Par Health USA, LLCNDC labeler code 49884
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 070346
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Renal K+ Excretion (Physiologic effect)Increased Diuresis (Physiologic effect)
- Identifiers
- Product ID 49884-117_51d2b75e-f9cc-4e26-996e-a07595e6f6e9SPL ID 51d2b75e-f9cc-4e26-996e-a07595e6f6e9SPL set ID e0cc2d44-436a-47e8-a890-589882fff4c4RxCUI 977880UNII 7M458Q65S3UPC 0349884117108, 0349884117016
- 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
N449884011701followed by a unit qualifier and the quantityPackage 49884-0117-01. 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 .
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 diur…
Excerpt only. Read the full label for complete information.
About NDC 49884-117
- What is NDC 49884-117?
- 49884-117 is the product NDC for Amiloride Hydrochloride, Amiloride hydrochloride anhydrous 5 mg/1 tablet, listed with the FDA by Par Health USA, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Amiloride Hydrochloride.
- What is the active ingredient?
- Amiloride hydrochloride anhydrous.
- Who is the labeler?
- Par Health USA, LLC, NDC labeler code 49884. 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 5 mg/1 | TabletOral | Padagis US LLC | 0574-0292 | 00574-0292-01 |