Telmisartan NDC 65162-293

NDC codes

FDA NDC Directory

Product NDC (as listed)65162-293Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65162-0293Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
65162-293-03	65162029303	30 TABLET in 1 BOTTLE (65162-293-03)Marketed from May 31, 2013
65162-293-09	65162029309	90 TABLET in 1 BOTTLE (65162-293-09)Marketed from May 31, 2013
65162-293-11	65162029311	1000 TABLET in 1 BOTTLE (65162-293-11)Marketed from May 31, 2013
65162-293-50	65162029350	500 TABLET in 1 BOTTLE (65162-293-50)Marketed from May 31, 2013
65162-293-63	65162029363	3 BLISTER PACK in 1 CARTON (65162-293-63) / 10 TABLET in 1 BLISTER PACKMarketed from May 31, 2013

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: Amneal Pharmaceuticals LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204415
Marketing start: May 31, 2013
Listing expires: Dec 31, 2026
Other FDA classes: Angiotensin 2 Receptor Antagonists (Mechanism)
Identifiers: Product ID 65162-293_1a0e1325-40d8-4dde-8655-54f6bd962a4fSPL ID 1a0e1325-40d8-4dde-8655-54f6bd962a4fSPL set ID 20a60231-64f0-4751-aa81-6c0e64334179RxCUI 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

N465162029303 followed by a unit qualifier and the quantity

Package 65162-0293-03. 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 Sep 30, 2023. 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) 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 pha…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 204415

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 204415
Product	Strength	Form · route	Labeler	Product NDC
Telmisartan	Telmisartan 40 mg/1	TabletOral	Amneal Pharmaceuticals of New York LLC	53746-292
Telmisartan	Telmisartan 20 mg/1	TabletOral	Amneal Pharmaceuticals of New York LLC	53746-291
Telmisartan	Telmisartan 80 mg/1	TabletOral	Amneal Pharmaceuticals of New York LLC	53746-293
Telmisartan	Telmisartan 40 mg/1	TabletOral	AvKARE	42291-791
Telmisartan	Telmisartan 20 mg/1	TabletOral	AvKARE	42291-790
Telmisartan	Telmisartan 80 mg/1	TabletOral	AvKARE	42291-792
Telmisartan	Telmisartan 20 mg/1	TabletOral	Amneal Pharmaceuticals LLC	65162-291
Telmisartan	Telmisartan 40 mg/1	TabletOral	Amneal Pharmaceuticals LLC	65162-292