Prescription drug · ANDA
Triamterene and Hydrochlorothiazide NDC 68084-750
Triamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1 · Tablet · Oral · American Health Packaging
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68084-750-25 | 68084075025 | 30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-750-25) / 1 TABLET in 1 BLISTER PACK (68084-750-95)Marketed from Mar 21, 2016 |
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
- American Health Packaging
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 071251
- 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 68084-750_2b33a7d8-dfd0-3f8c-e063-6294a90abae3SPL ID 2b33a7d8-dfd0-3f8c-e063-6294a90abae3SPL set ID ba764ce4-36fe-4aa4-96a4-d0479b875b4fRxCUI 310812UNII 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
N468084075025followed by a unit qualifier and the quantityPackage 68084-0750-25. 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 .
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.
Other NDCs under ANDA 071251
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| 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 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 |
| Triamterene and Hydrochlorothiazide | Triamterene 75 mg/1; Hydrochlorothiazide 50 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-431 |
- openFDA data updated
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