Prescription drug · NDA
Dyrenium (Triamterene) NDC 59212-003
Triamterene 100 mg/1 · Capsule · Oral · Advanz Pharma (US) Corp.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59212-003-01 | 5921200030159212000301 | 100 CAPSULE in 1 BOTTLE (59212-003-01)Marketed from Jan 1, 1999 |
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)
- Dyrenium
- Generic name (nonproprietary)
- triamterene
- Active ingredients
- Triamterene — 100 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Advanz Pharma (US) Corp.NDC labeler code 59212
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 013174
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Renal K+ Excretion (Physiologic effect)Increased Diuresis (Physiologic effect)
- Identifiers
- Product ID 59212-003_a617b947-1315-4f6e-8fd2-9697906de9acSPL ID a617b947-1315-4f6e-8fd2-9697906de9acSPL set ID ebb177c0-d45d-4443-a85a-e76bd9931a42RxCUI 198312, 198313, 208674, 208675UNII WS821Z52LQUPC 0359212002013, 0359212003010
- Pharmacologic class
- Potassium-sparing 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
N459212000301followed by a unit qualifier and the quantityPackage 59212-0003-01. 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 Dyrenium (triamterene) is indicated in the treatment of edema associated with congestive heart failure, cirrhosis of the liver and the nephrotic syndrome; steroid-induced edema, idiopathic edema and edema due to secondary hyperaldosteronism. Dyrenium may be used alone or with other diuretics, either for its added diuretic effect or its potassium-sparing potential. It also promotes increased diuresis when patients prove resistant or only partially responsive to thiazides or other diuretics because of secondary hyperaldosteronism. Usage in Pregnancy . The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary ha…
Excerpt only. Read the full label for complete information.
About NDC 59212-003
- What is NDC 59212-003?
- 59212-003 is the product NDC for Dyrenium (triamterene), Triamterene 100 mg/1 capsule, listed with the FDA by Advanz Pharma (US) Corp.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dyrenium (Triamterene).
- What is the active ingredient?
- Triamterene.
- Who is the labeler?
- Advanz Pharma (US) Corp., NDC labeler code 59212. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Dyrenium?
- 1 other product NDC are listed under this name. See all Dyrenium NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Dyrenium products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Dyreniumtriamterene | Triamterene 50 mg/1 | CapsuleOral | Advanz Pharma (US) Corp. | 59212-002 | 59212-0002-01 |
Other NDCs under NDA 013174
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 |
|---|---|---|---|---|
| Dyreniumtriamterene | Triamterene 50 mg/1 | CapsuleOral | Advanz Pharma (US) Corp. | 59212-002 |
| triamterene | Triamterene 50 mg/1 | CapsuleOral | Prasco Laboratories | 66993-831 |
| Triamterene | Triamterene 100 mg/1 | CapsuleOral | Prasco Laboratories | 66993-832 |