Triamterene and Hydrochlorothiazide NDC 71610-431

NDC codes

FDA NDC Directory

Product NDC (as listed)71610-431Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71610-0431Add 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
71610-431-45	71610043145	45 TABLET in 1 BOTTLE (71610-431-45)Marketed from Jun 3, 2020
71610-431-60	71610043160	90 TABLET in 1 BOTTLE (71610-431-60)Marketed from Oct 23, 2020

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): Triamterene and Hydrochlorothiazide
Generic name (nonproprietary): triamterene and hydrochlorothiazide
Active ingredients: Triamterene — 75 mg/1Hydrochlorothiazide — 50 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 071251
Marketing start: Sep 21, 2009
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 71610-431_c0313858-c1ee-40d9-9197-b6059869a430SPL ID c0313858-c1ee-40d9-9197-b6059869a430SPL set ID 191b9e48-7d44-4378-9f3f-b4a999080c8cRxCUI 310818UNII WS821Z52LQ, 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

N471610043145 followed by a unit qualifier and the quantity

Package 71610-0431-45. 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 Nov 12, 2020.

Indications (excerpt from the label)

INDICATIONS AND USAGE This fixed combination drug is not indicated for the initial therapy of edema or hypertension except in individuals in whom the development of hypokalemia cannot be risked. Triamterene and hydrochlorothiazide tablets are indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone. Triamterene and hydrochlorothiazide is also indicated for those patients who require a thiazide diuretic and in whom the development of hypokalemia cannot be risked (e.g., patients on concomitant digitalis preparations, or with a history of cardiac arryhthmias, etc.). Triamterene and hydrochlorothiazide may be used alone or in combinati…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 071251

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 071251
Product	Strength	Form · route	Labeler	Product NDC
Triamterene and Hydrochlorothiazide	Triamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1	TabletOral	Apotex Corp.	60505-2656
Triamterene and Hydrochlorothiazide	Triamterene 75 mg/1; Hydrochlorothiazide 50 mg/1	TabletOral	Apotex Corp.	60505-2657
Triamterene and Hydrochlorothiazide	Triamterene 75 mg/1; Hydrochlorothiazide 50 mg/1	TabletOral	Bryant Ranch Prepack	71335-0326
Triamterene and Hydrochlorothiazide	Triamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1	TabletOral	Bryant Ranch Prepack	71335-0356
Triamterene and Hydrochlorothiazide	Triamterene 75 mg/1; Hydrochlorothiazide 50 mg/1	TabletOral	Northwind Health Company, LLC	51655-582
Triamterene and Hydrochlorothiazide	Triamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1	TabletOral	Northwind Health Company, LLC	51655-630
Triamterene and Hydrochlorothiazide	Triamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-605
Triamterene and Hydrochlorothiazide	Triamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1	TabletOral	Golden State Medical Supply, Inc.	51407-286
Triamterene and Hydrochlorothiazide	Triamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1	TabletOral	American Health Packaging	68084-750
Triamterene and Hydrochlorothiazide	Triamterene 75 mg/1; Hydrochlorothiazide 50 mg/1	TabletOral	BluePoint Laboratories	68001-328
Triamterene and Hydrochlorothiazide	Triamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1	TabletOral	BluePoint Laboratories	68001-327
Triamterene and Hydrochlorothiazide	Triamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-684
Triamterene and Hydrochlorothiazide	Triamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	72789-183