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 LimitedNDC labeler code 65841
- 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 .
About NDC 65841-804
- What is NDC 65841-804?
- 65841-804 is the product NDC for telmisartan, Telmisartan 20 mg/1 tablet, listed with the FDA by Zydus Lifesciences Limited. It has 6 package NDCs, 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?
- Zydus Lifesciences Limited, NDC labeler code 65841. 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 20 mg/1 | TabletOral | Lifestar Pharma LLC | 70756-312 | 70756-0312-3070756-0312-99 |
| Telmisartan | Telmisartan 40 mg/1 | TabletOral | Lifestar Pharma LLC | 70756-313 | 70756-0313-3070756-0313-80 |
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 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 |
| telmisartan | Telmisartan 40 mg/1 | TabletOral | Zydus Lifesciences Limited | 65841-805 |
| telmisartan | Telmisartan 80 mg/1 | TabletOral | Zydus Lifesciences Limited | 65841-806 |