Prescription drug · ANDA
triamterene and hydrochlorothiazide NDC 70771-1361
Triamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1 · Tablet · Oral · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70771-1361-0 | 70771136100 | 1000 TABLET in 1 BOTTLE (70771-1361-0)Marketed from Sep 4, 2018 | |
| 70771-1361-1 | 70771136101 | 100 TABLET in 1 BOTTLE (70771-1361-1)Marketed from Sep 4, 2018 | |
| 70771-1361-4 | 70771136104 | 10 BLISTER PACK in 1 CARTON (70771-1361-4) / 10 TABLET in 1 BLISTER PACKMarketed from Sep 4, 2018 | |
| 70771-1361-5 | 70771136105 | 500 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 Limited
- 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 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
N470771136100followed by a unit qualifier and the quantityPackage 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
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 75 mg/1; Hydrochlorothiazide 50 mg/1 | TabletOral | A-S Medication Solutions | 50090-6736 |
| triamterene and hydrochlorothiazide | Triamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-602 |
| 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 |