Telmisartan And Hydrochlorothiazide NDC 43547-441

NDC codes

FDA NDC Directory

Product NDC (as listed)43547-441Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43547-0441Add 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	Copy
43547-441-03	43547044103	30 TABLET in 1 BOTTLE (43547-441-03)Marketed from Feb 5, 2018
43547-441-09	43547044109	90 TABLET in 1 BOTTLE (43547-441-09)Marketed from Feb 5, 2018

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 And Hydrochlorothiazide
Generic name (nonproprietary): telmisartan and hydrochlorothiazide
Active ingredients: Telmisartan — 40 mg/1Hydrochlorothiazide — 12.5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Solco Healthcare LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209028
Marketing start: Feb 5, 2018
Listing expires: Dec 31, 2026
Other FDA classes: Angiotensin 2 Receptor Antagonists (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
Identifiers: Product ID 43547-441_a7294951-f71f-442b-9f8e-2551963db085SPL ID a7294951-f71f-442b-9f8e-2551963db085SPL set ID 47c8eee0-f0b7-4bd8-97e9-0029aa1b37dbRxCUI 283316, 283317, 477130UNII 0J48LPH2TH, U5SYW473RQUPC 0343547442095, 0343547441098, 0343547443092
Pharmacologic class: Angiotensin 2 Receptor Blocker; Thiazide Diuretic

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

N443547044103 followed by a unit qualifier and the quantity

Package 43547-0441-03. 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 Jun 30, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Telmisartan and hydrochlorothiazide 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 pharmacologic classes including the classes to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with telmisartan and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 209028

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

FDA NDC Directory listings under ANDA 209028
Product	Strength	Form · route	Labeler	Product NDC
Telmisartan And Hydrochlorothiazide	Telmisartan 80 mg/1; Hydrochlorothiazide 12.5 mg/1	TabletOral	Solco Healthcare LLC	43547-442
Telmisartan And Hydrochlorothiazide	Telmisartan 80 mg/1; Hydrochlorothiazide 25 mg/1	TabletOral	Solco Healthcare LLC	43547-443