Prescription drug · ANDA
Telmisartan and Hydrochlorothiazide NDC 42291-464
Telmisartan 80 mg/1; Hydrochlorothiazide 25 mg/1 · Tablet · Oral · AvKARE
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42291-464-30 | 42291046430 | 3 BLISTER PACK in 1 BOX (42291-464-30) / 10 TABLET in 1 BLISTER PACK (42291-464-11)Marketed from Jun 18, 2024 |
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 — 80 mg/1Hydrochlorothiazide — 25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- AvKARE
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202544
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
- Identifiers
- Product ID 42291-464_5afb1a80-6024-d7fa-e063-6394a90a7ca2SPL ID 5afb1a80-6024-d7fa-e063-6394a90a7ca2SPL set ID 1b303136-dccd-178b-e063-6394a90a35f8RxCUI 283316, 283317, 477130UNII 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
N442291046430followed by a unit qualifier and the quantityPackage 42291-0464-30. 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 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.
Other NDCs under ANDA 202544
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 |
|---|---|---|---|---|
| Telmisartan and Hydrochlorothiazide | Telmisartan 40 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | AvKARE | 42291-462 |
| Telmisartan and Hydrochlorothiazide | Telmisartan 80 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | AvKARE | 42291-463 |
| Telmisartan and Hydrochlorothiazide | Telmisartan 80 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | Glenmark Pharmaceuticals Inc., USA | 68462-842 |
| Telmisartan and Hydrochlorothiazide | Telmisartan 40 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | Glenmark Pharmaceuticals Inc., USA | 68462-840 |
| Telmisartan and Hydrochlorothiazide | Telmisartan 80 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | Glenmark Pharmaceuticals Inc., USA | 68462-841 |