Prescription drug · ANDA
Telmisartan NDC 46708-609
Telmisartan 40 mg/1 · Tablet · Oral · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-609-30 | 46708060930 | 30 TABLET in 1 BOTTLE (46708-609-30)Marketed from Jun 25, 2016 | |
| 46708-609-91 | 46708060991 | 1000 TABLET in 1 BOTTLE (46708-609-91)Marketed from Jun 25, 2016 |
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
- Generic name (nonproprietary)
- telmisartan
- Active ingredients
- Telmisartan — 40 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 202130
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 46708-609_9d5f0653-75d0-4c6d-81e9-d34f2e62a714SPL ID 9d5f0653-75d0-4c6d-81e9-d34f2e62a714SPL set ID 4be6575f-ea8d-4cd8-a49d-3d1c93f2621aRxCUI 205304, 205305, 282755UNII U5SYW473RQ
- Pharmacologic class
- Angiotensin 2 Receptor Blocker
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
N446708060930followed by a unit qualifier and the quantityPackage 46708-0609-30. 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)
Telmisartanis an angiotensin II receptor blocker (ARB) indicated for: Treatment of hypertension to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions(1.1) 1.1 Hypertension Telmisartan 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 class to which this drug principally belongs. Control of high blood press…
Excerpt only. Read the full label for complete information.
About NDC 46708-609
- What is NDC 46708-609?
- 46708-609 is the product NDC for Telmisartan, Telmisartan 40 mg/1 tablet, listed with the FDA by Alembic Pharmaceuticals Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Telmisartan.
- What is the active ingredient?
- Telmisartan.
- 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?
- 79 other product NDCs are listed under this name. See all Telmisartan NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Telmisartan 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 | Telmisartan 20 mg/1 | TabletOral | NorthStar RxLLC | 72603-831 | 72603-0831-01 |
| Telmisartan | Telmisartan 40 mg/1 | TabletOral | NorthStar RxLLC | 72603-832 | 72603-0832-01 |
| Telmisartan | Telmisartan 80 mg/1 | TabletOral | NorthStar RxLLC | 72603-833 | 72603-0833-01 |
| Telmisartan | Telmisartan 20 mg/1 | TabletOral | Redpharm Drug | 67296-2284 | 67296-2284-09 |
| Telmisartan | Telmisartan 40 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4034 | 68788-4034-03 |
| Telmisartan | Telmisartan 80 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-120 | 33342-0120-0733342-0120-10 |
| Telmisartan | Telmisartan 20 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-118 | 33342-0118-0733342-0118-10 |
| Telmisartan | Telmisartan 40 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-119 | 33342-0119-0733342-0119-10 |
| Telmisartan | Telmisartan 20 mg/1 | TabletOral | Lifestar Pharma LLC | 70756-312 | 70756-0312-3070756-0312-99 |
| Telmisartan | Telmisartan 40 mg/1 | TabletOral | Lifestar Pharma LLC | 70756-313 | 70756-0313-3070756-0313-80 |
Other NDCs under ANDA 202130
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 | Telmisartan 20 mg/1 | TabletOral | Alembic Pharmaceuticals Inc. | 62332-087 |
| Telmisartan | Telmisartan 40 mg/1 | TabletOral | Alembic Pharmaceuticals Inc. | 62332-088 |
| Telmisartan | Telmisartan 80 mg/1 | TabletOral | Alembic Pharmaceuticals Inc. | 62332-089 |
| Telmisartan | Telmisartan 20 mg/1 | TabletOral | Alembic Pharmaceuticals Limited | 46708-608 |
| Telmisartan | Telmisartan 80 mg/1 | TabletOral | Alembic Pharmaceuticals Limited | 46708-610 |