Prescription drug · ANDA
Trandolapril NDC 65862-165
Trandolapril 2 mg/1 · Tablet · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65862-165-01 | 6586201650165862016501 | 100 TABLET in 1 BOTTLE (65862-165-01)Marketed from Jun 12, 2007 | |
| 65862-165-99 | 6586201659965862016599 | 1000 TABLET in 1 BOTTLE (65862-165-99)Marketed from Jun 12, 2007 |
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
- Generic name (nonproprietary)
- trandolapril
- Active ingredients
- Trandolapril — 2 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Aurobindo Pharma LimitedNDC labeler code 65862
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078438
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin-converting Enzyme Inhibitors (Mechanism)
- Identifiers
- Product ID 65862-165_004262f3-c8d0-43c9-a760-641c22748858SPL ID 004262f3-c8d0-43c9-a760-641c22748858SPL set ID 6f25ed16-e5e9-4170-b4b4-3b460887779eRxCUI 199351, 199352, 199353UNII 1T0N3G9CRC
- Pharmacologic class
- Angiotensin Converting Enzyme Inhibitor
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
N465862016501followed by a unit qualifier and the quantityPackage 65862-0165-01. 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 Hypertension Trandolapril tablets USP are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive medication such as hydrochlorothiazide. Heart Failure Post Myocardial Infarction or Left-Ventricular Dysfunction Post Myocardial Infarction Trandolapril tablets USP are indicated in stable patients who have evidence of left-ventricular systolic dysfunction (identified by wall motion abnormalities) or who are symptomatic from congestive heart failure within the first few days after sustaining acute myocardial infarction. Administration of trandolapril to Caucasian patients has been shown to decrease the risk of death …
Excerpt only. Read the full label for complete information.
About NDC 65862-165
- What is NDC 65862-165?
- 65862-165 is the product NDC for Trandolapril, Trandolapril 2 mg/1 tablet, listed with the FDA by Aurobindo Pharma Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Trandolapril.
- What is the active ingredient?
- Trandolapril.
- Who is the labeler?
- Aurobindo Pharma Limited, NDC labeler code 65862. 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?
- 12 other product NDCs are listed under this name. See all Trandolapril NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Trandolapril products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Trandolapriltrandolapril tablets | Trandolapril 1 mg/1 | TabletOral | Epic Pharma, LLC | 42806-052 | 42806-0052-0142806-0052-10 |
| Trandolapriltrandolapril tablets | Trandolapril 2 mg/1 | TabletOral | Epic Pharma, LLC | 42806-053 | 42806-0053-0142806-0053-10 |
| Trandolapriltrandolapril tablets | Trandolapril 4 mg/1 | TabletOral | Epic Pharma, LLC | 42806-054 | 42806-0054-0142806-0054-10 |
| Trandolapril | Trandolapril 1 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 57237-089 | 57237-0089-01 |
| Trandolapril | Trandolapril 2 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 57237-090 | 57237-0090-01 |
| Trandolapril | Trandolapril 4 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 57237-091 | 57237-0091-01 |
| Trandolapril | Trandolapril 1 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-164 | 65862-0164-0165862-0164-99 |
| Trandolapril | Trandolapril 2 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1431 | 71335-1431-0171335-1431-02 |
| Trandolapril | Trandolapril 2 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8003 | 63629-8003-0163629-8003-02 |
| Trandolapril | Trandolapril 1 mg/1 | TabletOral | Lupin Pharmaceuticals, Inc. | 68180-566 | 68180-0566-01 |
Other NDCs under ANDA 078438
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 | Trandolapril 1 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 57237-089 |
| Trandolapril | Trandolapril 2 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 57237-090 |
| Trandolapril | Trandolapril 4 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 57237-091 |
| Trandolapril | Trandolapril 1 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-164 |
| Trandolapril | Trandolapril 2 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1431 |