Prescription drug · ANDA
Telmisartan and Hydrochlorothiazide NDC 68180-193
Hydrochlorothiazide 12.5 mg/1; Telmisartan 40 mg/1 · Tablet · Oral · Lupin Pharmaceuticals, Inc.
NDC codes
FDA NDC DirectoryProduct information
- Brand name (proprietary)
- Telmisartan and Hydrochlorothiazide
- Generic name (nonproprietary)
- telmisartan and hydrochlorothiazide
- Active ingredients
- Hydrochlorothiazide — 12.5 mg/1Telmisartan — 40 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Lupin Pharmaceuticals, Inc.NDC labeler code 68180
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091351
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
- Identifiers
- Product ID 68180-193_92888a3c-daab-4cd1-b883-6ecbe682faa9SPL ID 92888a3c-daab-4cd1-b883-6ecbe682faa9SPL set ID b88054b3-fafa-4b4e-acf5-5294e5555720RxCUI 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.
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Telmisartan and hydrochlorothiazide tablets are combination of an angiotensin II receptor blocker (ARB) and a thiazide diuretic indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions ( 1 ) Telmisartan and hydrochlorothiazide tablets are not indicated for initial therapy ( 1 ) 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 myocar…
Excerpt only. Read the full label for complete information.
About NDC 68180-193
- What is NDC 68180-193?
- 68180-193 is the product NDC for Telmisartan and Hydrochlorothiazide, Hydrochlorothiazide 12.5 mg/1; Telmisartan 40 mg/1 tablet, listed with the FDA by Lupin Pharmaceuticals, Inc..
- What drug is associated with this NDC?
- Telmisartan and Hydrochlorothiazide.
- What is the active ingredient?
- Hydrochlorothiazide, Telmisartan.
- Who is the labeler?
- Lupin Pharmaceuticals, Inc., NDC labeler code 68180. 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 and Hydrochlorothiazide?
- 22 other product NDCs are listed under this name. See all Telmisartan and Hydrochlorothiazide NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Telmisartan and Hydrochlorothiazide products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| telmisartan and hydrochlorothiazide | Telmisartan 40 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | Lifestar Pharma LLC | 70756-315 | 70756-0315-3070756-0315-3170756-0315-99 |
| telmisartan and hydrochlorothiazide | Telmisartan 80 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | Lifestar Pharma LLC | 70756-316 | 70756-0316-3070756-0316-3170756-0316-99 |
| telmisartan and hydrochlorothiazide | Telmisartan 80 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | Lifestar Pharma LLC | 70756-317 | 70756-0317-3070756-0317-3170756-0317-99 |
| Telmisartan and Hydrochlorothiazide | Telmisartan 40 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | AvKARE | 42291-462 | 42291-0462-30 |
| Telmisartan and Hydrochlorothiazide | Telmisartan 80 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | AvKARE | 42291-463 | 42291-0463-30 |
| Telmisartan and Hydrochlorothiazide | Telmisartan 80 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | AvKARE | 42291-464 | 42291-0464-30 |
| Telmisartan and Hydrochlorothiazide | Telmisartan 40 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | Glenmark Pharmaceuticals Inc., USA | 68462-840 | 68462-0840-13 |
| Telmisartan and Hydrochlorothiazide | Telmisartan 80 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | Glenmark Pharmaceuticals Inc., USA | 68462-841 | 68462-0841-13 |
| Telmisartan and Hydrochlorothiazide | Telmisartan 80 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | Glenmark Pharmaceuticals Inc., USA | 68462-842 | 68462-0842-13 |
| Telmisartan And Hydrochlorothiazide | Telmisartan 40 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | Solco Healthcare LLC | 43547-441 | 43547-0441-0343547-0441-09 |
Other NDCs under ANDA 091351
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 | Hydrochlorothiazide 12.5 mg/1; Telmisartan 80 mg/1 | TabletOral | Lupin Pharmaceuticals, Inc. | 68180-194 |
| Telmisartan and Hydrochlorothiazide | Hydrochlorothiazide 25 mg/1; Telmisartan 80 mg/1 | TabletOral | Lupin Pharmaceuticals, Inc. | 68180-195 |