Prescription drug · ANDA
Triamterene and Hydrochlorothiazide NDC 0781-2074
Triamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1 · Capsule · Oral · Sandoz Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0781-2074-01 | 00781207401 | 100 CAPSULE in 1 BOTTLE (0781-2074-01)Marketed from Jun 5, 1997 | |
| 0781-2074-10 | 00781207410 | 1000 CAPSULE in 1 BOTTLE (0781-2074-10)Marketed from Jun 5, 1997 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Capsule
- Route
- Oral
- Labeler
- Sandoz Inc
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074821
- 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 0781-2074_f27ca7ea-9494-4119-a882-76103a96ba17SPL ID f27ca7ea-9494-4119-a882-76103a96ba17SPL set ID f824b6ba-bd1c-41a8-8f6f-ad507b48f3e0RxCUI 198316UNII 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
N400781207401followed by a unit qualifier and the quantityPackage 00781-2074-01. 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 . 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 is 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. Triamterene and hydrochlorothiazide may be used alone or as an adjunct to other antihypertensive drugs, such as beta-blockers. Since triamterene and hydrochlorothiazide may enhance …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 074821
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 | CapsuleOral | NuCare Pharmaceuticals, Inc. | 68071-3879 |
| Triamterene and Hydrochlorothiazide | Triamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1 | CapsuleOral | Northwind Health Company, LLC | 51655-722 |
| Triamterene and Hydrochlorothiazide | Triamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1 | CapsuleOral | Proficient Rx LP | 63187-465 |
| Triamterene and Hydrochlorothiazide | Triamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-8732 |
| Triamterene and Hydrochlorothiazide | Triamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-6944 |