NDC codes

FDA NDC Directory
Product NDC (as listed)43547-285Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43547-0285Add 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
43547-285-03435470285034354702850330 TABLET in 1 BOTTLE (43547-285-03)Marketed from Aug 20, 2017
43547-285-09435470285094354702850990 TABLET in 1 BOTTLE (43547-285-09)Marketed from Aug 20, 2017
43547-285-504354702855043547028550500 TABLET in 1 BOTTLE (43547-285-50)Marketed from Aug 20, 2017

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
Solco Healthcare US, LLCNDC labeler code 43547
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 207882
Marketing start
Listing expires
Other FDA classes
Angiotensin 2 Receptor Antagonists (Mechanism)
Identifiers
Product ID 43547-285_98f95e17-f88b-4f47-b4bb-5db8f93793f7SPL ID 98f95e17-f88b-4f47-b4bb-5db8f93793f7SPL set ID 77442f0b-b522-4b19-ac1f-f0ce8576f0beRxCUI 205304, 205305, 282755UNII U5SYW473RQUPC 0343547285036, 0343547284039, 0343547283032

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

N443547028503 followed by a unit qualifier and the quantity

Package 43547-0285-03. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

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 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 pharm…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 43547-285

What is NDC 43547-285?
43547-285 is the product NDC for Telmisartan, Telmisartan 80 mg/1 tablet, listed with the FDA by Solco Healthcare US, LLC. It has 3 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?
Solco Healthcare US, LLC, NDC labeler code 43547. 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 40 mg/1TabletOralMacleods Pharmaceuticals Limited33342-11933342-0119-0733342-0119-10
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

All 80 Telmisartan NDCs

Other NDCs under ANDA 207882

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

FDA NDC Directory listings under ANDA 207882
ProductStrengthForm · routeLabelerProduct NDC
TelmisartanTelmisartan 20 mg/1TabletOralSolco Healthcare US, LLC43547-283
TelmisartanTelmisartan 40 mg/1TabletOralSolco Healthcare US, LLC43547-284
TelmisartanTelmisartan 80 mg/1TabletOralNuCare Pharmaceuticals, Inc.68071-3892
TelmisartanTelmisartan 40 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-8665
TelmisartanTelmisartan 80 mg/1TabletOralREMEDYREPACK INC.70518-3556
TelmisartanTelmisartan 40 mg/1TabletOralBryant Ranch Prepack71335-2173
TelmisartanTelmisartan 80 mg/1TabletOralBryant Ranch Prepack71335-2191

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