NDC codes

FDA NDC Directory
Product NDC (as listed)33342-119Labeler and product segments. Claims need a package NDC.
Product NDC at billing width33342-0119Add 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 NDC11-digit (billing)PackageCopy
33342-119-07333420119073334201190730 TABLET in 1 CONTAINER (33342-119-07)Marketed from Jan 15, 2025
33342-119-10333420119103334201191090 TABLET in 1 CONTAINER (33342-119-10)Marketed from Jan 15, 2025

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
Labeler
Macleods Pharmaceuticals LimitedNDC labeler code 33342
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 203986
Marketing start
Listing expires
Other FDA classes
Angiotensin 2 Receptor Antagonists (Mechanism)
Identifiers
Product ID 33342-119_94abae59-69ec-482d-b4cf-285d502d82e7SPL ID 94abae59-69ec-482d-b4cf-285d502d82e7SPL set ID 671d5a85-4146-43b4-9d7d-ca53268eb2a6RxCUI 205304, 205305, 282755UNII U5SYW473RQUPC 0333342120106, 0333342119070, 0333342118073, 0333342119100, 0333342120076

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

N433342011907 followed by a unit qualifier and the quantity

Package 33342-0119-07. 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 tablets, 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 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 33342-119

What is NDC 33342-119?
33342-119 is the product NDC for Telmisartan, Telmisartan 40 mg/1 tablet, listed with the FDA by Macleods Pharmaceuticals Limited. It has 2 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?
Macleods Pharmaceuticals Limited, NDC labeler code 33342. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Telmisartan NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
TelmisartanTelmisartan 20 mg/1TabletOralRedpharm Drug67296-228467296-2284-09
TelmisartanTelmisartan 40 mg/1TabletOralNorthStar RxLLC72603-83272603-0832-01
TelmisartanTelmisartan 20 mg/1TabletOralNorthStar RxLLC72603-83172603-0831-01
TelmisartanTelmisartan 80 mg/1TabletOralNorthStar RxLLC72603-83372603-0833-01
TelmisartanTelmisartan 40 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-403468788-4034-03
TelmisartanTelmisartan 20 mg/1TabletOralMacleods Pharmaceuticals Limited33342-11833342-0118-0733342-0118-10
TelmisartanTelmisartan 80 mg/1TabletOralMacleods Pharmaceuticals Limited33342-12033342-0120-0733342-0120-10
TelmisartanTelmisartan 80 mg/1TabletOralLifestar Pharma LLC70756-31470756-0314-3070756-0314-80
TelmisartanTelmisartan 20 mg/1TabletOralLifestar Pharma LLC70756-31270756-0312-3070756-0312-99
TelmisartanTelmisartan 40 mg/1TabletOralLifestar Pharma LLC70756-31370756-0313-3070756-0313-80

All 80 Telmisartan NDCs

Other NDCs under ANDA 203986

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

FDA NDC Directory listings under ANDA 203986
ProductStrengthForm · routeLabelerProduct NDC
TelmisartanTelmisartan 20 mg/1TabletOralMacleods Pharmaceuticals Limited33342-118
TelmisartanTelmisartan 80 mg/1TabletOralMacleods Pharmaceuticals Limited33342-120
TelmisartanTelmisartan 20 mg/1TabletOralRedpharm Drug67296-2284
TelmisartanTelmisartan 20 mg/1TabletOralNorthStar RxLLC72603-831
TelmisartanTelmisartan 40 mg/1TabletOralNorthStar RxLLC72603-832
TelmisartanTelmisartan 80 mg/1TabletOralNorthStar RxLLC72603-833

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