Prescription drug · ANDA
triamterene and hydrochlorothiazide NDC 50090-6736
Triamterene 75 mg/1; Hydrochlorothiazide 50 mg/1 · Tablet · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-6736-0 | 50090673600 | 30 TABLET in 1 BOTTLE (50090-6736-0)Marketed from Oct 12, 2023 | |
| 50090-6736-2 | 50090673602 | 100 TABLET in 1 BOTTLE (50090-6736-2)Marketed from Oct 20, 2023 | |
| 50090-6736-5 | 50090673605 | 90 TABLET in 1 BOTTLE (50090-6736-5)Marketed from Oct 20, 2023 |
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
- A-S Medication Solutions
- 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 50090-6736_33ee2725-84e2-49fa-a0b4-ac4fcd1ec16fSPL ID 33ee2725-84e2-49fa-a0b4-ac4fcd1ec16fSPL set ID 27b8f965-d73f-411c-aae6-bcae6e281113RxCUI 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
N450090673600followed by a unit qualifier and the quantityPackage 50090-6736-00. 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.
Other NDCs under ANDA 208360
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 | A-S Medication Solutions | 50090-5801 |
| triamterene and hydrochlorothiazide | Triamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-602 |
| triamterene and hydrochlorothiazide | Triamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1361 |
| triamterene and hydrochlorothiazide | Triamterene 75 mg/1; Hydrochlorothiazide 50 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1362 |
| triamterene and hydrochlorothiazide | Triamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | Zydus Pharmaceuticals (USA) Inc. | 68382-856 |
| triamterene and hydrochlorothiazide | Triamterene 75 mg/1; Hydrochlorothiazide 50 mg/1 | TabletOral | Zydus Pharmaceuticals (USA) Inc. | 68382-857 |