Prescription drug · ANDA
Telmisartan and Hydrochlorothiazide NDC 46708-209
Telmisartan 40 mg/1; Hydrochlorothiazide 12.5 mg/1 · Tablet · Oral · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-209-10 | 4670802091046708020910 | 100 TABLET in 1 CARTON (46708-209-10)Marketed from Mar 14, 2014 | |
| 46708-209-30 | 4670802093046708020930 | 30 TABLET in 1 BOTTLE (46708-209-30)Marketed from Mar 14, 2014 | |
| 46708-209-91 | 4670802099146708020991 | 1000 TABLET in 1 BOTTLE (46708-209-91)Marketed from Mar 14, 2014 |
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
- Alembic Pharmaceuticals LimitedNDC labeler code 46708
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203010
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
- Identifiers
- Product ID 46708-209_7c37a82a-77c2-4d49-84ee-ee4f70b4ec93SPL ID 7c37a82a-77c2-4d49-84ee-ee4f70b4ec93SPL set ID 5b476740-e3f0-4f68-b07c-cd9eb2fa27caRxCUI 283316, 283317, 477130UNII 0J48LPH2TH, U5SYW473RQUPC 0346708211301, 0346708209308, 0346708210304
- 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
N446708020910followed by a unit qualifier and the quantityPackage 46708-0209-10. 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.
About NDC 46708-209
- What is NDC 46708-209?
- 46708-209 is the product NDC for Telmisartan and Hydrochlorothiazide, Telmisartan 40 mg/1; Hydrochlorothiazide 12.5 mg/1 tablet, listed with the FDA by Alembic Pharmaceuticals Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Telmisartan and Hydrochlorothiazide.
- What is the active ingredient?
- Telmisartan, Hydrochlorothiazide.
- Who is the labeler?
- Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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 203010
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 80 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | Alembic Pharmaceuticals Limited | 46708-210 |
| Telmisartan and Hydrochlorothiazide | Telmisartan 80 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | Alembic Pharmaceuticals Limited | 46708-211 |
| Telmisartan and Hydrochlorothiazide | Telmisartan 40 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | Alembic Pharmaceuticals Inc. | 62332-209 |
| Telmisartan and Hydrochlorothiazide | Telmisartan 80 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | Alembic Pharmaceuticals Inc. | 62332-210 |
| Telmisartan and Hydrochlorothiazide | Telmisartan 80 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | Alembic Pharmaceuticals Inc. | 62332-211 |