Prescription drug · ANDA
Triamterene and Hydrochlorothiazide NDC 55289-090
Triamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1 · Tablet · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55289-090-15 | 55289009015 | 15 TABLET in 1 BOTTLE, PLASTIC (55289-090-15)Marketed from Jan 20, 2017 | |
| 55289-090-30 | 55289009030 | 30 TABLET in 1 BOTTLE, PLASTIC (55289-090-30)Marketed from Feb 11, 2016 | |
| 55289-090-90 | 55289009090 | 90 TABLET in 1 BOTTLE, PLASTIC (55289-090-90)Marketed from Feb 16, 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
- PD-Rx Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 073449
- 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 55289-090_41999499-b90e-0afa-e063-6294a90aea28SPL ID 41999499-b90e-0afa-e063-6294a90aea28SPL set ID e505484d-b600-4d13-a4b9-278dc4a2e73aRxCUI 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
N455289009015followed by a unit qualifier and the quantityPackage 55289-0090-15. 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 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 alon…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 073449
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 | Bryant Ranch Prepack | 71335-0968 |
| Triamterene and Hydrochlorothiazide | Triamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | Preferred Pharmaceuticals, Inc. | 68788-7526 |
| Triamterene and Hydrochlorothiazide | Triamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2371 |
| Triamterene and Hydrochlorothiazide | Triamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | A-S Medication Solutions | 50090-1270 |
| Triamterene and Hydrochlorothiazide | Triamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-1662 |
| Triamterene and Hydrochlorothiazide | Triamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | BluePoint Laboratories | 68001-387 |
| Triamterene and Hydrochlorothiazide | Triamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | Actavis Pharma, Inc. | 0591-0424 |
| Triamterene and Hydrochlorothiazide | Triamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-1834 |