NDC codes

FDA NDC Directory
Product NDC (as listed)70771-1361Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70771-1361Add 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 NDC11-digit (billing)PackageCopy
70771-1361-070771136100707711361001000 TABLET in 1 BOTTLE (70771-1361-0)Marketed from Sep 4, 2018
70771-1361-17077113610170771136101100 TABLET in 1 BOTTLE (70771-1361-1)Marketed from Sep 4, 2018
70771-1361-4707711361047077113610410 BLISTER PACK in 1 CARTON (70771-1361-4) / 10 TABLET in 1 BLISTER PACKMarketed from Sep 4, 2018
70771-1361-57077113610570771136105500 TABLET in 1 BOTTLE (70771-1361-5)Marketed from Sep 4, 2018

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 Lifesciences LimitedNDC labeler code 70771
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 208360
Marketing start
Listing expires
Other FDA classes
Decreased Renal K+ Excretion (Physiologic effect)Increased Diuresis (Physiologic effect)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
Identifiers
Product ID 70771-1361_1b1be913-613c-469c-8665-13858922d5bfSPL ID 1b1be913-613c-469c-8665-13858922d5bfSPL set ID 1af80800-e7a5-42e5-aa6c-3f61aff4a77bRxCUI 310812, 310818UNII 0J48LPH2TH, WS821Z52LQ
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

N470771136100 followed by a unit qualifier and the quantity

Package 70771-1361-00. 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 . 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)

About NDC 70771-1361

What is NDC 70771-1361?
70771-1361 is the product NDC for triamterene and hydrochlorothiazide, Triamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1 tablet, listed with the FDA by Zydus Lifesciences Limited. 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 Lifesciences Limited, NDC labeler code 70771. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Triamterene and HydrochlorothiazideTriamterene 75 mg/1; Hydrochlorothiazide 50 mg/1TabletOralREMEDYREPACK INC.70518-435170518-4351-00
Triamterene and HydrochlorothiazideTriamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1CapsuleOralMacleods Pharmaceuticals Limited33342-46733342-0467-1133342-0467-44
Triamterene and HydrochlorothiazideTriamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1CapsuleOralREMEDYREPACK INC.70518-427070518-4270-00
Triamterene and HydrochlorothiazideTriamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1CapsuleOralPreferred Pharmaceuticals Inc.68788-870068788-8700-0168788-8700-0368788-8700-06+1 more
Triamterene and HydrochlorothiazideTriamterene 75 mg/1; Hydrochlorothiazide 50 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-862468788-8624-0168788-8624-0368788-8624-06+1 more
Triamterene and HydrochlorothiazideTriamterene 75 mg/1; Hydrochlorothiazide 50 mg/1TabletOralNorthwind Health Company, LLC82868-03282868-0032-3082868-0032-90
Triamterene and HydrochlorothiazideTriamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1CapsuleOralNorthwind Health Company, LLC82868-02282868-0022-30
Triamterene and HydrochlorothiazideTriamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1TabletOralNorthwind Health Company, LLC82868-00682868-0006-3082868-0006-90
Triamterene and HydrochlorothiazideTriamterene 75 mg/1; Hydrochlorothiazide 50 mg/1TabletOralNorthwind Health Company, LLC51655-58251655-0582-2651655-0582-52
Triamterene and HydrochlorothiazideTriamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1CapsuleOralSt. Mary's Medical Park Pharmacy60760-78360760-0783-90

All 69 triamterene and hydrochlorothiazide NDCs

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
ProductStrengthForm · routeLabelerProduct NDC
triamterene and hydrochlorothiazideTriamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1TabletOralA-S Medication Solutions50090-5801
triamterene and hydrochlorothiazideTriamterene 75 mg/1; Hydrochlorothiazide 50 mg/1TabletOralA-S Medication Solutions50090-6736
triamterene and hydrochlorothiazideTriamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1TabletOralZydus Pharmaceuticals (USA) Inc.68382-856
triamterene and hydrochlorothiazideTriamterene 75 mg/1; Hydrochlorothiazide 50 mg/1TabletOralZydus Pharmaceuticals (USA) Inc.68382-857
triamterene and hydrochlorothiazideTriamterene 75 mg/1; Hydrochlorothiazide 50 mg/1TabletOralZydus Lifesciences Limited70771-1362
triamterene and hydrochlorothiazideTriamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-602

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