Prescription drug · ANDA
Triamterene and Hydrochlorothiazide NDC 63629-2585
Triamterene 75 mg/1; Hydrochlorothiazide 50 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-2585-1 | 63629258501 | 30 TABLET in 1 BOTTLE (63629-2585-1)Marketed from Jan 7, 2005 | |
| 63629-2585-2 | 63629258502 | 15 TABLET in 1 BOTTLE (63629-2585-2)Marketed from Sep 23, 2010 | |
| 63629-2585-3 | 63629258503 | 90 TABLET in 1 BOTTLE (63629-2585-3)Marketed from Jul 31, 2015 | |
| 63629-2585-4 | 63629258504 | 100 TABLET in 1 BOTTLE (63629-2585-4)Marketed from Dec 22, 2021 | |
| 63629-2585-5 | 63629258505 | 7 TABLET in 1 BOTTLE (63629-2585-5)Marketed from Sep 25, 2019 |
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 — 75 mg/1Hydrochlorothiazide — 50 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 071851
- 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 63629-2585_b5846d98-0f70-4df4-8f9a-13780b09f96aSPL ID b5846d98-0f70-4df4-8f9a-13780b09f96aSPL set ID 4c74bc01-1065-79f0-f9c4-044ead38a55dRxCUI 310818UNII 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
N463629258501followed by a unit qualifier and the quantityPackage 63629-2585-01. 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 .
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.
Other NDCs under ANDA 071851
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 75 mg/1; Hydrochlorothiazide 50 mg/1 | TabletOral | BluePoint Laboratories | 68001-388 |
| 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 | Actavis Pharma, Inc. | 0591-0348 |
| Triamterene and Hydrochlorothiazide | Triamterene 75 mg/1; Hydrochlorothiazide 50 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-4687 |
| Triamterene and Hydrochlorothiazide | Triamterene 75 mg/1; Hydrochlorothiazide 50 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 55289-488 |