Micardis HCT NDC 0597-0043

NDC codes

FDA NDC Directory

Product NDC (as listed)0597-0043Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00597-0043Add 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
0597-0043-37	00597004337	3 BLISTER PACK in 1 CARTON (0597-0043-37) / 10 TABLET in 1 BLISTER PACKMarketed from Dec 1, 2000

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): Micardis HCT
Generic name (nonproprietary): telmisartan and hydrochlorothiazide
Active ingredients: Telmisartan — 40 mg/1Hydrochlorothiazide — 12.5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Boehringer Ingelheim Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 021162
Marketing start: Dec 1, 2000
Listing expires: Dec 31, 2026
Other FDA classes: Angiotensin 2 Receptor Antagonists (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
Identifiers: Product ID 0597-0043_ea1ff12a-df9e-477b-9e91-f89381987c6dSPL ID ea1ff12a-df9e-477b-9e91-f89381987c6dSPL set ID b078dae2-664d-4144-847a-3b9d9b557402RxCUI 283316, 283317, 477130, 749833, 749837, 749841UNII 0J48LPH2TH, U5SYW473RQ
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

N400597004337 followed by a unit qualifier and the quantity

Package 00597-0043-37. 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 Dec 31, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

MICARDIS HCT (telmisartan and hydrochlorothiazide) is 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 MICARDIS HCT. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy,…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 021162

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

FDA NDC Directory listings under NDA 021162
Product	Strength	Form · route	Labeler	Product NDC
Micardis HCTtelmisartan and hydrochlorothiazide	Telmisartan 80 mg/1; Hydrochlorothiazide 12.5 mg/1	TabletOral	Boehringer Ingelheim Pharmaceuticals, Inc.	0597-0044
Micardis HCTtelmisartan and hydrochlorothiazide	Telmisartan 80 mg/1; Hydrochlorothiazide 25 mg/1	TabletOral	Boehringer Ingelheim Pharmaceuticals, Inc.	0597-0042