Prescription drug · NDA
Micardis HCT (Telmisartan and hydrochlorothiazide) NDC 0597-0043
Telmisartan 40 mg/1; Hydrochlorothiazide 12.5 mg/1 · Tablet · Oral · Boehringer Ingelheim Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0597-0043-37 | 0059700433700597004337 | 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.NDC labeler code 0597
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021162
- Marketing start
- Listing expires
- 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
N400597004337followed by a unit qualifier and the quantityPackage 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 . 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.
About NDC 0597-0043
- What is NDC 0597-0043?
- 0597-0043 is the product NDC for Micardis HCT, Telmisartan 40 mg/1; Hydrochlorothiazide 12.5 mg/1 tablet, listed with the FDA by Boehringer Ingelheim Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Micardis HCT (Telmisartan and hydrochlorothiazide).
- What is the active ingredient?
- Telmisartan, Hydrochlorothiazide.
- Who is the labeler?
- Boehringer Ingelheim Pharmaceuticals, Inc., NDC labeler code 0597. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Micardis HCT?
- 2 other product NDCs are listed under this name. See all Micardis HCT NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Micardis HCT products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Micardis HCTtelmisartan and hydrochlorothiazide | Telmisartan 80 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0042 | 00597-0042-37 |
| Micardis HCTtelmisartan and hydrochlorothiazide | Telmisartan 80 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0044 | 00597-0044-37 |
Other NDCs under NDA 021162
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Micardis HCTtelmisartan and hydrochlorothiazide | Telmisartan 80 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0042 |
| Micardis HCTtelmisartan and hydrochlorothiazide | Telmisartan 80 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0044 |