Prescription drug · ANDA
Telmisartan NDC 43547-285
Telmisartan 80 mg/1 · Tablet · Oral · Solco Healthcare US, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43547-285-03 | 43547028503 | 30 TABLET in 1 BOTTLE (43547-285-03)Marketed from Aug 20, 2017 | |
| 43547-285-09 | 43547028509 | 90 TABLET in 1 BOTTLE (43547-285-09)Marketed from Aug 20, 2017 | |
| 43547-285-50 | 43547028550 | 500 TABLET in 1 BOTTLE (43547-285-50)Marketed from Aug 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 — 80 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Solco Healthcare US, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207882
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 43547-285_98f95e17-f88b-4f47-b4bb-5db8f93793f7SPL ID 98f95e17-f88b-4f47-b4bb-5db8f93793f7SPL set ID 77442f0b-b522-4b19-ac1f-f0ce8576f0beRxCUI 205304, 205305, 282755UNII U5SYW473RQUPC 0343547285036, 0343547284039, 0343547283032
- 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
N443547028503followed by a unit qualifier and the quantityPackage 43547-0285-03. 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 is 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 pharm…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 207882
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 80 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3892 |
| Telmisartan | Telmisartan 40 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2173 |
| Telmisartan | Telmisartan 80 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2191 |
| Telmisartan | Telmisartan 20 mg/1 | TabletOral | Solco Healthcare US, LLC | 43547-283 |
| Telmisartan | Telmisartan 40 mg/1 | TabletOral | Solco Healthcare US, LLC | 43547-284 |
| Telmisartan | Telmisartan 40 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8665 |
| Telmisartan | Telmisartan 80 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3556 |