Prescription drug · ANDA
Telmisartan NDC 42291-790
Telmisartan 20 mg/1 · Tablet · Oral · AvKARE
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42291-790-30 | 4229107903042291079030 | 30 TABLET in 1 BOTTLE (42291-790-30)Marketed from Dec 20, 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)
- Telmisartan
- Generic name (nonproprietary)
- telmisartan
- Active ingredients
- Telmisartan — 20 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- AvKARENDC labeler code 42291
- 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 42291-790_4875af35-46c7-d9e6-e063-6394a90ab93dSPL ID 4875af35-46c7-d9e6-e063-6394a90ab93dSPL set ID 71902893-55da-4286-8b25-b528641489efRxCUI 205304, 205305, 282755UNII 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
N442291079030followed by a unit qualifier and the quantityPackage 42291-0790-30. 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) 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 pharmacologic classes including the class to which this drug principally belongs. Contr…
Excerpt only. Read the full label for complete information.
About NDC 42291-790
- What is NDC 42291-790?
- 42291-790 is the product NDC for Telmisartan, Telmisartan 20 mg/1 tablet, listed with the FDA by AvKARE. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Telmisartan.
- What is the active ingredient?
- Telmisartan.
- Who is the labeler?
- AvKARE, NDC labeler code 42291. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Telmisartan?
- 79 other product NDCs are listed under this name. See all Telmisartan NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Telmisartan products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Telmisartan | Telmisartan 20 mg/1 | TabletOral | Redpharm Drug | 67296-2284 | 67296-2284-09 |
| Telmisartan | Telmisartan 40 mg/1 | TabletOral | NorthStar RxLLC | 72603-832 | 72603-0832-01 |
| Telmisartan | Telmisartan 20 mg/1 | TabletOral | NorthStar RxLLC | 72603-831 | 72603-0831-01 |
| Telmisartan | Telmisartan 80 mg/1 | TabletOral | NorthStar RxLLC | 72603-833 | 72603-0833-01 |
| Telmisartan | Telmisartan 40 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4034 | 68788-4034-03 |
| Telmisartan | Telmisartan 20 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-118 | 33342-0118-0733342-0118-10 |
| Telmisartan | Telmisartan 40 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-119 | 33342-0119-0733342-0119-10 |
| Telmisartan | Telmisartan 80 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-120 | 33342-0120-0733342-0120-10 |
| Telmisartan | Telmisartan 80 mg/1 | TabletOral | Lifestar Pharma LLC | 70756-314 | 70756-0314-3070756-0314-80 |
| Telmisartan | Telmisartan 20 mg/1 | TabletOral | Lifestar Pharma LLC | 70756-312 | 70756-0312-3070756-0312-99 |
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 40 mg/1 | TabletOral | AvKARE | 42291-791 |
| Telmisartan | Telmisartan 80 mg/1 | TabletOral | AvKARE | 42291-792 |
| 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 | Amneal Pharmaceuticals of New York LLC | 53746-293 |
| 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 |