Prescription drug · ANDA
Trandolapril NDC 68180-566
Trandolapril 1 mg/1 · Tablet · Oral · Lupin Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68180-566-01 | 68180056601 | 100 TABLET in 1 BOTTLE (68180-566-01)Marketed from Jun 11, 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 — 1 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Lupin Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077522
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin-converting Enzyme Inhibitors (Mechanism)
- Identifiers
- Product ID 68180-566_97cefaf3-9c1f-43e3-a30c-e9631872a8e8SPL ID 97cefaf3-9c1f-43e3-a30c-e9631872a8e8SPL set ID 8143a6cf-dadc-4ef7-a8db-d16d7150ad34RxCUI 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
N468180056601followed by a unit qualifier and the quantityPackage 68180-0566-01. 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 are indicated for the treatment of hypertension. It 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 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 (principal…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 077522
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 2 mg/1 | TabletOral | Lupin Pharmaceuticals, Inc. | 68180-567 |
| Trandolapril | Trandolapril 4 mg/1 | TabletOral | Lupin Pharmaceuticals, Inc. | 68180-568 |
| Trandolapril | Trandolapril 2 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8003 |
- openFDA data updated
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Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.