Prescription drug · ANDA
telmisartan NDC 65841-804
Telmisartan 20 mg/1 · Tablet · Oral · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65841-804-01 | 65841080401 | 100 TABLET in 1 BOTTLE (65841-804-01)Marketed from Aug 27, 2014 | |
| 65841-804-05 | 65841080405 | 500 TABLET in 1 BOTTLE (65841-804-05)Marketed from Aug 27, 2014 | |
| 65841-804-06 | 65841080406 | 30 TABLET in 1 BOTTLE (65841-804-06)Marketed from Aug 27, 2014 | |
| 65841-804-10 | 65841080410 | 1000 TABLET in 1 BOTTLE (65841-804-10)Marketed from Aug 27, 2014 | |
| 65841-804-16 | 65841080416 | 90 TABLET in 1 BOTTLE (65841-804-16)Marketed from Aug 27, 2014 | |
| 65841-804-78 | 65841080478 | 30 BLISTER PACK in 1 CARTON (65841-804-78) / 1 TABLET in 1 BLISTER PACK (65841-804-30)Marketed from Aug 27, 2014 |
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
- Zydus Lifesciences Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203325
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 65841-804_9e0aa50a-1fac-4086-b7b6-811cec3f524bSPL ID 9e0aa50a-1fac-4086-b7b6-811cec3f524bSPL set ID 2e3cc412-fa44-4304-aabc-d6e412f81fbfRxCUI 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
N465841080401followed by a unit qualifier and the quantityPackage 65841-0804-01. 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 .
Other NDCs under ANDA 203325
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 | Zydus Lifesciences Limited | 65841-805 |
| telmisartan | Telmisartan 80 mg/1 | TabletOral | Zydus Lifesciences Limited | 65841-806 |
| telmisartan | Telmisartan 20 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 68382-471 |
| telmisartan | Telmisartan 40 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 68382-472 |
| telmisartan | Telmisartan 80 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 68382-473 |