Prescription drug · ANDA
Telmisartan NDC 50090-5490
Telmisartan 40 mg/1 · Tablet · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-5490-0 | 50090549000 | 90 TABLET in 1 BOTTLE, PLASTIC (50090-5490-0)Marketed from Mar 16, 2021 |
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)
- Telmisartan
- Generic name (nonproprietary)
- telmisartan
- Active ingredients
- Telmisartan — 40 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- A-S Medication Solutions
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202397
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 50090-5490_34322a88-3ab2-42a0-a13a-4ad31d5f0509SPL ID 34322a88-3ab2-42a0-a13a-4ad31d5f0509SPL set ID eaed12cd-5bfe-4c98-9afc-025ed86a294fRxCUI 205304UNII U5SYW473RQ
- 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
N450090549000followed by a unit qualifier and the quantityPackage 50090-5490-00. 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)
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…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 202397
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 | Mylan Pharmaceuticals Inc. | 0378-2920 |
| Telmisartan | Telmisartan 80 mg/1 | TabletOral | A-S Medication Solutions | 50090-5492 |
| Telmisartan | Telmisartan 40 mg/1 | TabletOral | Mylan Pharmaceuticals Inc. | 0378-2921 |
| Telmisartan | Telmisartan 80 mg/1 | TabletOral | Mylan Pharmaceuticals Inc. | 0378-2922 |