Prescription drug · ANDA
Telmisartan NDC 71209-050
Telmisartan 40 mg/1 · Tablet · Oral · Cadila Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71209-050-01 | 71209005001 | 30 TABLET in 1 BOTTLE (71209-050-01)Marketed from Dec 22, 2022 | |
| 71209-050-04 | 71209005004 | 90 TABLET in 1 BOTTLE (71209-050-04)Marketed from Dec 22, 2022 | |
| 71209-050-05 | 71209005005 | 100 TABLET in 1 BOTTLE (71209-050-05)Marketed from Dec 22, 2022 | |
| 71209-050-10 | 71209005010 | 500 TABLET in 1 BOTTLE (71209-050-10)Marketed from Dec 22, 2022 | |
| 71209-050-11 | 71209005011 | 1000 TABLET in 1 BOTTLE (71209-050-11)Marketed from Dec 22, 2022 | |
| 71209-050-16 | 71209005016 | 30 BLISTER PACK in 1 CARTON (71209-050-16) / 10 TABLET in 1 BLISTER PACKMarketed from Feb 5, 2015 | |
| 71209-050-18 | 71209005018 | 30 BLISTER PACK in 1 CARTON (71209-050-18) / 10 TABLET in 1 BLISTER PACKMarketed from Feb 5, 2015 |
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 — 40 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208605
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 71209-050_a19404d0-fd12-42ab-b469-b8c7d1d5e7ebSPL ID a19404d0-fd12-42ab-b469-b8c7d1d5e7ebSPL set ID 353fcb30-2fa7-4ff1-8a18-26f3ec279d00RxCUI 205304, 205305, 282755UNII U5SYW473RQUPC 0371209051118, 0371209049054, 0371209051101, 0371209050012, 0371209049115, 0371209050104, 0371209049016, 0371209049108, 0371209050043, 0371209051040, 0371209050111
- 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
N471209005001followed by a unit qualifier and the quantityPackage 71209-0050-01. 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)
SECTION 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, USP 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 208605
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 | Bryant Ranch Prepack | 72162-2439 |
| Telmisartan | Telmisartan 80 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2440 |
| Telmisartan | Telmisartan 80 mg/1 | TabletOral | Modavar Pharmaceuticals LLC | 72241-017 |
| Telmisartan | Telmisartan 20 mg/1 | TabletOral | Modavar Pharmaceuticals LLC | 72241-015 |
| Telmisartan | Telmisartan 40 mg/1 | TabletOral | Modavar Pharmaceuticals LLC | 72241-016 |
| Telmisartan | Telmisartan 80 mg/1 | TabletOral | Cadila Pharmaceuticals Limited | 71209-051 |
| Telmisartan | Telmisartan 20 mg/1 | TabletOral | Cadila Pharmaceuticals Limited | 71209-049 |
| Telmisartan | Telmisartan 20 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2438 |