Prescription drug · ANDA
Triamterene and Hydrochlorothiazide NDC 50090-7438
Triamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1 · Capsule · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-7438-0 | 5009074380050090743800 | 90 CAPSULE in 1 BOTTLE (50090-7438-0)Marketed from Nov 6, 2024 |
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
- Capsule
- Route
- Oral
- Labeler
- A-S Medication SolutionsNDC labeler code 50090
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208358
- 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 50090-7438_fc1dbc28-7b21-4dbd-82fd-454aaf13dd33SPL ID fc1dbc28-7b21-4dbd-82fd-454aaf13dd33SPL set ID d9fe1367-e725-4527-b515-95851d270b18RxCUI 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
N450090743800followed by a unit qualifier and the quantityPackage 50090-7438-00. 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 capsules are indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone. Triamterene and hydrochlorothiazide capsules 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 may be used alone or as an adjunct to other antihypertensive drugs, such as beta-blockers. Since triamterene and hyd…
Excerpt only. Read the full label for complete information.
About NDC 50090-7438
- What is NDC 50090-7438?
- 50090-7438 is the product NDC for Triamterene and Hydrochlorothiazide, Triamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1 capsule, listed with the FDA by A-S Medication Solutions. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Triamterene and Hydrochlorothiazide.
- What is the active ingredient?
- Triamterene, Hydrochlorothiazide.
- Who is the labeler?
- A-S Medication Solutions, NDC labeler code 50090. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Triamterene and Hydrochlorothiazide?
- 68 other product NDCs are listed under this name. See all Triamterene and Hydrochlorothiazide NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Triamterene and Hydrochlorothiazide products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Triamterene and Hydrochlorothiazide | Triamterene 75 mg/1; Hydrochlorothiazide 50 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4351 | 70518-4351-00 |
| Triamterene and Hydrochlorothiazide | Triamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1 | CapsuleOral | Macleods Pharmaceuticals Limited | 33342-467 | 33342-0467-1133342-0467-44 |
| Triamterene and Hydrochlorothiazide | Triamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4270 | 70518-4270-00 |
| Triamterene and Hydrochlorothiazide | Triamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-8700 | 68788-8700-0168788-8700-0368788-8700-06+1 more |
| Triamterene and Hydrochlorothiazide | Triamterene 75 mg/1; Hydrochlorothiazide 50 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8624 | 68788-8624-0168788-8624-0368788-8624-06+1 more |
| Triamterene and Hydrochlorothiazide | Triamterene 75 mg/1; Hydrochlorothiazide 50 mg/1 | TabletOral | Northwind Health Company, LLC | 82868-032 | 82868-0032-3082868-0032-90 |
| Triamterene and Hydrochlorothiazide | Triamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1 | CapsuleOral | Northwind Health Company, LLC | 82868-022 | 82868-0022-30 |
| Triamterene and Hydrochlorothiazide | Triamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | Northwind Health Company, LLC | 82868-006 | 82868-0006-3082868-0006-90 |
| Triamterene and Hydrochlorothiazide | Triamterene 75 mg/1; Hydrochlorothiazide 50 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-582 | 51655-0582-2651655-0582-52 |
| Triamterene and Hydrochlorothiazide | Triamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1 | CapsuleOral | St. Mary's Medical Park Pharmacy | 60760-783 | 60760-0783-90 |
Other NDCs under ANDA 208358
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 | 50090-7437 |
| Triamterene and Hydrochlorothiazide | Triamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1 | CapsuleOral | St. Mary's Medical Park Pharmacy | 60760-783 |
| Triamterene and Hydrochlorothiazide | Triamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-2533 |
| Triamterene and Hydrochlorothiazide | Triamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1 | CapsuleOral | Zydus Pharmaceuticals (USA) Inc. | 68382-855 |
| Triamterene and Hydrochlorothiazide | Triamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-8700 |
| Triamterene and Hydrochlorothiazide | Triamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4270 |
| Triamterene and Hydrochlorothiazide | Triamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1 | CapsuleOral | Zydus Lifesciences Limited | 70771-1474 |
| Triamterene and Hydrochlorothiazide | Triamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2034 |
| Triamterene and Hydrochlorothiazide | Triamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1 | CapsuleOral | Viona Pharmaceuticals Inc | 72578-090 |
| Triamterene and Hydrochlorothiazide | Triamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1 | CapsuleOral | Proficient Rx LP | 82804-308 |
| Triamterene and Hydrochlorothiazide | Triamterene 37.5 mg/1; Hydrochlorothiazide 25 mg/1 | CapsuleOral | Northwind Health Company, LLC | 82868-022 |