Prescription drug · ANDA
Telmisartan NDC 53746-293
Telmisartan 80 mg/1 · Tablet · Oral · Amneal Pharmaceuticals of New York LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53746-293-30 | 53746029330 | 30 TABLET in 1 BOTTLE (53746-293-30)Marketed from Sep 25, 2016 |
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)
- Telmisartan
- Generic name (nonproprietary)
- telmisartan
- Active ingredients
- Telmisartan — 80 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204415
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 53746-293_77cf7b02-2f68-41ff-be0d-8ad569613822SPL ID 77cf7b02-2f68-41ff-be0d-8ad569613822SPL set ID bf2dca37-ce9c-40e4-8ad6-b8186aa7fed1RxCUI 205304, 205305, 282755UNII U5SYW473RQUPC 0353746291301, 0353746293305, 0353746292308
- Pharmacologic class
- Angiotensin 2 Receptor Blocker
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
N453746029330followed by a unit qualifier and the quantityPackage 53746-0293-30. 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)
Telmisartan tablets are an angiotensin II receptor blocker (ARB) indicated for: Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1) Cardiovascular (CV) risk reduction in patients unable to take ACE inhibitors. (1.2) 1.1 Hypertension Telmisartan tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pha…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 204415
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 |
|---|---|---|---|---|
| Telmisartan | Telmisartan 20 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 53746-291 |
| Telmisartan | Telmisartan 40 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 53746-292 |
| Telmisartan | Telmisartan 80 mg/1 | TabletOral | AvKARE | 42291-792 |
| Telmisartan | Telmisartan 20 mg/1 | TabletOral | AvKARE | 42291-790 |
| Telmisartan | Telmisartan 40 mg/1 | TabletOral | AvKARE | 42291-791 |
| Telmisartan | Telmisartan 20 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-291 |
| Telmisartan | Telmisartan 40 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-292 |
| Telmisartan | Telmisartan 80 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-293 |