What is NDC 42794-005?

42794-005 is the product NDC for Amiloride Hydrochloride, Amiloride hydrochloride anhydrous 5 mg/1 tablet, listed with the FDA by Sigmapharm Laboratories, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

What is the active ingredient?

Amiloride hydrochloride anhydrous.

Sigmapharm Laboratories, LLC, NDC labeler code 42794. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Amiloride Hydrochloride NDC 42794-005 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)42794-005Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42794-0005Add 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 NDC	11-digit (billing)	Package	Copy
42794-005-02	42794000502	100 TABLET in 1 BOTTLE (42794-005-02)Marketed from Jun 14, 2021

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: Sigmapharm Laboratories, LLCNDC labeler code 42794
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 079133
Marketing start: Jun 14, 2021
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Renal K+ Excretion (Physiologic effect)Increased Diuresis (Physiologic effect)
Identifiers: Product ID 42794-005_f1f15fe7-63a8-4708-e053-2a95a90a7deaSPL ID f1f15fe7-63a8-4708-e053-2a95a90a7deaSPL set ID de12b6f3-3791-4d78-90e6-c487cf951738RxCUI 977880UNII 7M458Q65S3
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

N442794000502 followed by a unit qualifier and the quantity

Package 42794-0005-02. 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 Jan 10, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Amiloride HCl tablets are indicated as adjunctive treatment with thiazide diuretics or other kaliureticdiuretic 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 tablets have litt…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 42794-005

What is NDC 42794-005?: 42794-005 is the product NDC for Amiloride Hydrochloride, Amiloride hydrochloride anhydrous 5 mg/1 tablet, listed with the FDA by Sigmapharm Laboratories, 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 anhydrous.
Who is the labeler?: Sigmapharm Laboratories, LLC, NDC labeler code 42794. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
amiloride hydrochloride	Amiloride hydrochloride 5 mg/1	TabletOral	Padagis US LLC	0574-0292	00574-0292-01
Amiloride Hydrochloride	Amiloride hydrochloride anhydrous 5 mg/1	TabletOral	Par Health USA, LLC	49884-117	49884-0117-0149884-0117-10