Prescription drug · ANDA
Trandolapril and Verapamil Hydrochloride NDC 68462-296
Trandolapril 2 mg/1; Verapamil hydrochloride 240 mg/1 · Tablet, Film coated, Extended release · Oral · Glenmark Pharmaceuticals Inc., USA
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68462-296-01 | 6846202960168462029601 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-296-01)Marketed from Feb 25, 2015 | |
| 68462-296-10 | 6846202961068462029610 | 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-296-10)Marketed from Feb 25, 2015 | |
| 68462-296-90 | 6846202969068462029690 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-296-90)Marketed from Feb 25, 2015 |
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)
- Trandolapril and Verapamil Hydrochloride
- Generic name (nonproprietary)
- trandolapril and verapamil hydrochloride
- Active ingredients
- Trandolapril — 2 mg/1Verapamil hydrochloride — 240 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- Glenmark Pharmaceuticals Inc., USANDC labeler code 68462
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 079135
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin-converting Enzyme Inhibitors (Mechanism)Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
- Identifiers
- Product ID 68462-296_770b4914-a475-4841-83f8-79261f115effSPL ID 770b4914-a475-4841-83f8-79261f115effSPL set ID 39bad727-af4c-4d20-933b-7f287e88099aRxCUI 897781, 897783, 897844, 897853UNII V3888OEY5R, 1T0N3G9CRCUPC 0368462294017, 0368462329016
- Pharmacologic class
- Angiotensin Converting Enzyme Inhibitor; Calcium Channel 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
N468462029601followed by a unit qualifier and the quantityPackage 68462-0296-01. 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)
INDICATIONS AND USAGE Trandolapril and verapamil hydrochloride extended-release tablets are indicated for the treatment of hypertension. This fixed combination drug is not indicated for the initial therapy of hypertension (see DOSAGE AND ADMINISTRATION ). In using trandolapril and verapamil hydrochloride extended-release tablets, consideration should be given to the fact that an angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that trandolapril does not have similar risk (see WARNINGS - Neutropenia/Agranulocytosis ).
Excerpt only. Read the full label for complete information.
About NDC 68462-296
- What is NDC 68462-296?
- 68462-296 is the product NDC for Trandolapril and Verapamil Hydrochloride, Trandolapril 2 mg/1; Verapamil hydrochloride 240 mg/1 tablet, film coated, extended release, listed with the FDA by Glenmark Pharmaceuticals Inc., USA. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Trandolapril and Verapamil Hydrochloride.
- What is the active ingredient?
- Trandolapril, Verapamil hydrochloride.
- Who is the labeler?
- Glenmark Pharmaceuticals Inc., USA, NDC labeler code 68462. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Trandolapril and Verapamil Hydrochloride?
- 3 other product NDCs are listed under this name. See all Trandolapril and Verapamil Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Trandolapril and Verapamil Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Trandolapril and Verapamil Hydrochloride | Trandolapril 1 mg/1; Verapamil hydrochloride 240 mg/1 | Tablet, Film coated, Extended releaseOral | Glenmark Pharmaceuticals Inc., USA | 68462-294 | 68462-0294-0168462-0294-1068462-0294-90 |
| Trandolapril and Verapamil Hydrochloride | Trandolapril 2 mg/1; Verapamil hydrochloride 180 mg/1 | Tablet, Film coated, Extended releaseOral | Glenmark Pharmaceuticals Inc., USA | 68462-295 | 68462-0295-0168462-0295-1068462-0295-90 |
| Trandolapril and Verapamil Hydrochloride | Trandolapril 4 mg/1; Verapamil hydrochloride 240 mg/1 | Tablet, Film coated, Extended releaseOral | Glenmark Pharmaceuticals Inc., USA | 68462-329 | 68462-0329-0168462-0329-10 |
Other NDCs under ANDA 079135
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 |
|---|---|---|---|---|
| Trandolapril and Verapamil Hydrochloride | Trandolapril 1 mg/1; Verapamil hydrochloride 240 mg/1 | Tablet, Film coated, Extended releaseOral | Glenmark Pharmaceuticals Inc., USA | 68462-294 |
| Trandolapril and Verapamil Hydrochloride | Trandolapril 2 mg/1; Verapamil hydrochloride 180 mg/1 | Tablet, Film coated, Extended releaseOral | Glenmark Pharmaceuticals Inc., USA | 68462-295 |
| Trandolapril and Verapamil Hydrochloride | Trandolapril 4 mg/1; Verapamil hydrochloride 240 mg/1 | Tablet, Film coated, Extended releaseOral | Glenmark Pharmaceuticals Inc., USA | 68462-329 |