What is NDC 68001-388?

68001-388 is the product NDC for Triamterene and Hydrochlorothiazide, Triamterene 75 mg/1; Hydrochlorothiazide 50 mg/1 tablet, listed with the FDA by BluePoint Laboratories. It has 2 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Triamterene, Hydrochlorothiazide.

BluePoint Laboratories, NDC labeler code 68001. 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 68001-388

NDC codes

FDA NDC Directory

Product NDC (as listed)68001-388Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68001-0388Add 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
68001-388-00	6800103880068001038800	100 TABLET in 1 BOTTLE, PLASTIC (68001-388-00)Marketed from Jun 18, 2019
68001-388-03	6800103880368001038803	500 TABLET in 1 BOTTLE, PLASTIC (68001-388-03)Marketed from Jun 18, 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 — 75 mg/1Hydrochlorothiazide — 50 mg/1
Dosage form: Tablet
Route: Oral
Labeler: BluePoint LaboratoriesNDC labeler code 68001
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 071851
Marketing start: Jun 18, 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 68001-388_14ca7c10-0f45-bfdf-e063-6294a90ad956SPL ID 14ca7c10-0f45-bfdf-e063-6294a90ad956SPL set ID b8a55c23-b509-4790-88fa-9dc9bacd4bbeRxCUI 310812, 310818UNII 0J48LPH2TH, WS821Z52LQUPC 0368001387002, 0368001388009
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

N468001038800 followed by a unit qualifier and the quantity

Package 68001-0388-00. 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 Mar 29, 2024.

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 tablets 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 may be used alo…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68001-388

What is NDC 68001-388?: 68001-388 is the product NDC for Triamterene and Hydrochlorothiazide, Triamterene 75 mg/1; Hydrochlorothiazide 50 mg/1 tablet, listed with the FDA by BluePoint Laboratories. It has 2 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?: BluePoint Laboratories, NDC labeler code 68001. 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 071851

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

FDA NDC Directory listings under ANDA 071851
Product	Strength	Form · route	Labeler	Product NDC
Triamterene and Hydrochlorothiazide	Triamterene 75 mg/1; Hydrochlorothiazide 50 mg/1	TabletOral	A-S Medication Solutions	50090-1834
Triamterene and Hydrochlorothiazide	Triamterene 75 mg/1; Hydrochlorothiazide 50 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	55289-488
Triamterene and Hydrochlorothiazide	Triamterene 75 mg/1; Hydrochlorothiazide 50 mg/1	TabletOral	Bryant Ranch Prepack	63629-2585
Triamterene and Hydrochlorothiazide	Triamterene 75 mg/1; Hydrochlorothiazide 50 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-4687