Prescription drug · ANDA
Triamterene and Hydrochlorothiazide NDC 63187-905
Triamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1 · Capsule · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-905-30 | 63187090530 | 30 CAPSULE in 1 BOTTLE (63187-905-30)Marketed from Sep 1, 2017 | |
| 63187-905-60 | 63187090560 | 60 CAPSULE in 1 BOTTLE (63187-905-60)Marketed from Sep 1, 2017 | |
| 63187-905-90 | 63187090590 | 90 CAPSULE in 1 BOTTLE (63187-905-90)Marketed from Sep 1, 2017 |
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
- Capsule
- Route
- Oral
- Labeler
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201407
- 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 63187-905_bfe1a860-0657-4f48-9b82-31f9483838c4SPL ID bfe1a860-0657-4f48-9b82-31f9483838c4SPL set ID 189ad040-07e9-42a5-854c-67633367da74RxCUI 198316UNII WS821Z52LQ, 0J48LPH2THUPC 0363187905903
- 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
N463187090530followed by a unit qualifier and the quantityPackage 63187-0905-30. 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 capsules, USP are indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone. Triamterene and hydrochlorothiazide capsules, USP are also indicated for those patients who require a thiazide diuretic and in whom the development of hypokalemia cannot be risked. Triamterene and hydrochlorothiazide capsules, USP may be used alone or as an adjunct to other antihypertensive drugs, such as beta-blockers. Since tria…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 201407
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 | A-S Medication Solutions | 50090-2028 |
| Triamterene and Hydrochlorothiazide | Triamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-0504 |
| Triamterene and Hydrochlorothiazide | Triamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-1084 |
| Triamterene And Hydrochlorothiazide | Triamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1 | CapsuleOral | Chartwell RX, LLC | 62135-529 |