Prescription drug · ANDA
Telmisartan NDC 71335-2191
Telmisartan 80 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-2191-1 | 7133521910171335219101 | 90 TABLET in 1 BOTTLE (71335-2191-1)Marketed from Dec 1, 2022 | |
| 71335-2191-2 | 7133521910271335219102 | 30 TABLET in 1 BOTTLE (71335-2191-2)Marketed from Dec 1, 2022 | |
| 71335-2191-3 | 7133521910371335219103 | 180 TABLET in 1 BOTTLE (71335-2191-3)Marketed from Dec 1, 2022 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 80 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 71335
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207882
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 71335-2191_80eb0c2f-4281-43e4-af6f-366ab65b72f5SPL ID 80eb0c2f-4281-43e4-af6f-366ab65b72f5SPL set ID 830741dd-3f3c-4f8e-88c6-dc112166f477RxCUI 205305UNII 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
N471335219101followed by a unit qualifier and the quantityPackage 71335-2191-01. 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 is 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 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 class to which this drug principally belongs. Control of…
Excerpt only. Read the full label for complete information.
About NDC 71335-2191
- What is NDC 71335-2191?
- 71335-2191 is the product NDC for Telmisartan, Telmisartan 80 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 3 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?
- Bryant Ranch Prepack, NDC labeler code 71335. 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 | Redpharm Drug | 67296-2284 | 67296-2284-09 |
| Telmisartan | Telmisartan 40 mg/1 | TabletOral | NorthStar RxLLC | 72603-832 | 72603-0832-01 |
| Telmisartan | Telmisartan 20 mg/1 | TabletOral | NorthStar RxLLC | 72603-831 | 72603-0831-01 |
| Telmisartan | Telmisartan 80 mg/1 | TabletOral | NorthStar RxLLC | 72603-833 | 72603-0833-01 |
| Telmisartan | Telmisartan 40 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4034 | 68788-4034-03 |
| 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 80 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-120 | 33342-0120-0733342-0120-10 |
| Telmisartan | Telmisartan 80 mg/1 | TabletOral | Lifestar Pharma LLC | 70756-314 | 70756-0314-3070756-0314-80 |
| Telmisartan | Telmisartan 20 mg/1 | TabletOral | Lifestar Pharma LLC | 70756-312 | 70756-0312-3070756-0312-99 |
Other NDCs under ANDA 207882
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 | Solco Healthcare US, LLC | 43547-283 |
| Telmisartan | Telmisartan 40 mg/1 | TabletOral | Solco Healthcare US, LLC | 43547-284 |
| Telmisartan | Telmisartan 80 mg/1 | TabletOral | Solco Healthcare US, LLC | 43547-285 |
| Telmisartan | Telmisartan 80 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3892 |
| Telmisartan | Telmisartan 40 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8665 |
| Telmisartan | Telmisartan 80 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3556 |
| Telmisartan | Telmisartan 40 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2173 |