triamterene and hydrochlorothiazide NDC 68382-856

NDC codes

FDA NDC Directory

Product NDC (as listed)68382-856Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68382-0856Add 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
68382-856-01	68382085601	100 TABLET in 1 BOTTLE (68382-856-01)Marketed from Sep 4, 2018
68382-856-05	68382085605	500 TABLET in 1 BOTTLE (68382-856-05)Marketed from Sep 4, 2018
68382-856-10	68382085610	1000 TABLET in 1 BOTTLE (68382-856-10)Marketed from Sep 4, 2018
68382-856-77	68382085677	10 BLISTER PACK in 1 CARTON (68382-856-77) / 10 TABLET in 1 BLISTER PACK (68382-856-30)Marketed from Sep 4, 2018

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 — 37.5 mg/1Hydrochlorothiazide — 25 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Zydus Pharmaceuticals (USA) Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208360
Marketing start: Sep 4, 2018
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 68382-856_e0a51d55-991a-463a-a382-428f33488d77SPL ID e0a51d55-991a-463a-a382-428f33488d77SPL set ID fa69eeb8-ec82-4be1-8cb7-f64094ed957cRxCUI 310812, 310818UNII WS821Z52LQ, 0J48LPH2THUPC 0368382856012, 0368382857019
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

N468382085601 followed by a unit qualifier and the quantity

Package 68382-0856-01. 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 Aug 26, 2023. This label includes a boxed warning.

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, USP are indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone. Triamterene and hydrochlorothiazide tablets, USP are 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 arrhythmias, etc.). Triamterene and hydrochlorothiazide tablets, USP m…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 208360

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

FDA NDC Directory listings under ANDA 208360
Product	Strength	Form · route	Labeler	Product NDC
triamterene and hydrochlorothiazide	Triamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1	TabletOral	A-S Medication Solutions	50090-5801
triamterene and hydrochlorothiazide	Triamterene 75 mg/1; Hydrochlorothiazide 50 mg/1	TabletOral	A-S Medication Solutions	50090-6736
triamterene and hydrochlorothiazide	Triamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-602
triamterene and hydrochlorothiazide	Triamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1361
triamterene and hydrochlorothiazide	Triamterene 75 mg/1; Hydrochlorothiazide 50 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1362
triamterene and hydrochlorothiazide	Triamterene 75 mg/1; Hydrochlorothiazide 50 mg/1	TabletOral	Zydus Pharmaceuticals (USA) Inc.	68382-857