What is NDC 68382-855?

68382-855 is the product NDC for Triamterene and Hydrochlorothiazide, Triamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1 capsule, listed with the FDA by Zydus Pharmaceuticals (USA) Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Triamterene, Hydrochlorothiazide.

Zydus Pharmaceuticals (USA) Inc., NDC labeler code 68382. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Triamterene and Hydrochlorothiazide?

68 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Triamterene and Hydrochlorothiazide NDC 68382-855

NDC codes

FDA NDC Directory

Product NDC (as listed)68382-855Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68382-0855Add 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
68382-855-01	6838208550168382085501	100 CAPSULE in 1 BOTTLE (68382-855-01)Marketed from Mar 31, 2019
68382-855-05	6838208550568382085505	500 CAPSULE in 1 BOTTLE (68382-855-05)Marketed from Mar 31, 2019
68382-855-10	6838208551068382085510	1000 CAPSULE in 1 BOTTLE (68382-855-10)Marketed from Mar 31, 2019
68382-855-77	6838208557768382085577	10 BLISTER PACK in 1 CARTON (68382-855-77) / 10 CAPSULE in 1 BLISTER PACK (68382-855-30)Marketed from Mar 31, 2019

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: Capsule
Route: Oral
Labeler: Zydus Pharmaceuticals (USA) Inc.NDC labeler code 68382
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208358
Marketing start: Mar 31, 2019
Listing expires: Dec 31, 2027
Other FDA classes: Decreased Renal K+ Excretion (Physiologic effect)Increased Diuresis (Physiologic effect)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
Identifiers: Product ID 68382-855_062dc3f3-09ea-4f21-9435-025c4e9d460bSPL ID 062dc3f3-09ea-4f21-9435-025c4e9d460bSPL set ID ee11db7b-91bd-4231-8783-889d98e4fa32RxCUI 198316UNII 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

N468382085501 followed by a unit qualifier and the quantity

Package 68382-0855-01. 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 Feb 23, 2019. 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 capsules, USP are indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone. Triamterene and hydrochlorothiazide capsules, USP are also indicated for those patients who require a thiazide diuretic and in whom the development of hypokalemia cannot be risked. Triamterene and hydrochlorothiazide capsules, USP may be used alone or as an adjunct to other antihypertensive drugs, such as beta-blockers. Since tria…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68382-855

What is NDC 68382-855?: 68382-855 is the product NDC for Triamterene and Hydrochlorothiazide, Triamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1 capsule, listed with the FDA by Zydus Pharmaceuticals (USA) Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Triamterene and Hydrochlorothiazide.
What is the active ingredient?: Triamterene, Hydrochlorothiazide.
Who is the labeler?: Zydus Pharmaceuticals (USA) Inc., NDC labeler code 68382. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Triamterene and Hydrochlorothiazide?: 68 other product NDCs are listed under this name. See all Triamterene and Hydrochlorothiazide 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 Triamterene and Hydrochlorothiazide NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Triamterene and Hydrochlorothiazide	Triamterene 75 mg/1; Hydrochlorothiazide 50 mg/1	TabletOral	REMEDYREPACK INC.	70518-4351	70518-4351-00
Triamterene and Hydrochlorothiazide	Triamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1	CapsuleOral	Macleods Pharmaceuticals Limited	33342-467	33342-0467-1133342-0467-44
Triamterene and Hydrochlorothiazide	Triamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-4270	70518-4270-00
Triamterene and Hydrochlorothiazide	Triamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1	CapsuleOral	Preferred Pharmaceuticals Inc.	68788-8700	68788-8700-0168788-8700-0368788-8700-06+1 more
Triamterene and Hydrochlorothiazide	Triamterene 75 mg/1; Hydrochlorothiazide 50 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-8624	68788-8624-0168788-8624-0368788-8624-06+1 more
Triamterene and Hydrochlorothiazide	Triamterene 75 mg/1; Hydrochlorothiazide 50 mg/1	TabletOral	Northwind Health Company, LLC	82868-032	82868-0032-3082868-0032-90
Triamterene and Hydrochlorothiazide	Triamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1	CapsuleOral	Northwind Health Company, LLC	82868-022	82868-0022-30
Triamterene and Hydrochlorothiazide	Triamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1	TabletOral	Northwind Health Company, LLC	82868-006	82868-0006-3082868-0006-90
Triamterene and Hydrochlorothiazide	Triamterene 75 mg/1; Hydrochlorothiazide 50 mg/1	TabletOral	Northwind Health Company, LLC	51655-582	51655-0582-2651655-0582-52
Triamterene and Hydrochlorothiazide	Triamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1	CapsuleOral	St. Mary's Medical Park Pharmacy	60760-783	60760-0783-90

All 69 Triamterene and Hydrochlorothiazide NDCs

Other NDCs under ANDA 208358

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

FDA NDC Directory listings under ANDA 208358
Product	Strength	Form · route	Labeler	Product NDC
Triamterene and Hydrochlorothiazide	Triamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1	CapsuleOral	A-S Medication Solutions	50090-7437
Triamterene and Hydrochlorothiazide	Triamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1	CapsuleOral	A-S Medication Solutions	50090-7438
Triamterene and Hydrochlorothiazide	Triamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1	CapsuleOral	St. Mary's Medical Park Pharmacy	60760-783
Triamterene and Hydrochlorothiazide	Triamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1	CapsuleOral	NuCare Pharmaceuticals,Inc.	68071-2533
Triamterene and Hydrochlorothiazide	Triamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1	CapsuleOral	Preferred Pharmaceuticals Inc.	68788-8700
Triamterene and Hydrochlorothiazide	Triamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-4270
Triamterene and Hydrochlorothiazide	Triamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1	CapsuleOral	Zydus Lifesciences Limited	70771-1474
Triamterene and Hydrochlorothiazide	Triamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-2034
Triamterene and Hydrochlorothiazide	Triamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1	CapsuleOral	Viona Pharmaceuticals Inc	72578-090
Triamterene and Hydrochlorothiazide	Triamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1	CapsuleOral	Proficient Rx LP	82804-308
Triamterene and Hydrochlorothiazide	Triamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1	CapsuleOral	Northwind Health Company, LLC	82868-022