What is NDC 0555-0483?

0555-0483 is the product NDC for Amiloride Hydrochloride and Hydrochlorothiazide, Amiloride hydrochloride 5 mg/1; Hydrochlorothiazide 50 mg/1 tablet, listed with the FDA by Teva Pharmaceuticals USA, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Amiloride hydrochloride, Hydrochlorothiazide.

Teva Pharmaceuticals USA, Inc., NDC labeler code 0555. 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 and Hydrochlorothiazide?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

NDC 0555-0483

NDC codes

FDA NDC Directory

Product NDC (as listed)0555-0483Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00555-0483Add 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
0555-0483-02	0055504830200555048302	100 TABLET in 1 BOTTLE (0555-0483-02)Marketed from Dec 1, 1989
0555-0483-05	0055504830500555048305	1000 TABLET in 1 BOTTLE (0555-0483-05)Marketed from Dec 1, 1989

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 and Hydrochlorothiazide
Generic name (nonproprietary): amiloride hydrochloride and hydrochlorothiazide
Active ingredients: Amiloride hydrochloride — 5 mg/1Hydrochlorothiazide — 50 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Teva Pharmaceuticals USA, Inc.NDC labeler code 0555
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 071111
Marketing start: Dec 1, 1989
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Renal K+ Excretion (Physiologic effect)Increased Diuresis (Physiologic effect)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
Identifiers: Product ID 0555-0483_3c6d3a11-6d0b-4109-89cd-658827847feaSPL ID 3c6d3a11-6d0b-4109-89cd-658827847feaSPL set ID 8b2c581a-f955-4a8e-bf85-e768e903fd10RxCUI 977883UNII FZJ37245UC, 0J48LPH2TH
Pharmacologic class: Potassium-sparing Diuretic; Thiazide 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

N400555048302 followed by a unit qualifier and the quantity

Package 00555-0483-02. 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 Dec 27, 2022. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Amiloride hydrochloride and hydrochlorothiazide tablets are indicated in those patients with hypertension or with congestive heart failure who develop hypokalemia when thiazides or other kaliuretic diuretics are used alone, or in whom maintenance of normal serum potassium levels is considered to be clinically important, 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 hydrochloride and hydrochlorothiazide tablets may be used alone or as an adjunct to other antihy…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0555-0483

What is NDC 0555-0483?: 0555-0483 is the product NDC for Amiloride Hydrochloride and Hydrochlorothiazide, Amiloride hydrochloride 5 mg/1; Hydrochlorothiazide 50 mg/1 tablet, listed with the FDA by Teva Pharmaceuticals USA, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Amiloride Hydrochloride and Hydrochlorothiazide.
What is the active ingredient?: Amiloride hydrochloride, Hydrochlorothiazide.
Who is the labeler?: Teva Pharmaceuticals USA, Inc., NDC labeler code 0555. 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 and Hydrochlorothiazide?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Amiloride Hydrochloride and Hydrochlorothiazide NDC 0555-0483