Trandolapril (trandolapril tablets) NDC 42806-053

NDC codes

FDA NDC Directory

Product NDC (as listed)42806-053Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42806-0053Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
42806-053-01	42806005301	100 TABLET in 1 BOTTLE (42806-053-01)Marketed from Mar 31, 2015
42806-053-10	42806005310	1000 TABLET in 1 BOTTLE (42806-053-10)Marketed from Mar 31, 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
Generic name (nonproprietary): trandolapril tablets
Active ingredients: Trandolapril — 2 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Epic Pharma, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078508
Marketing start: Mar 31, 2015
Listing expires: Dec 31, 2026
Other FDA classes: Angiotensin-converting Enzyme Inhibitors (Mechanism)
Identifiers: Product ID 42806-053_71e96bed-1a18-49d6-e053-2995a90a3014SPL ID 71e96bed-1a18-49d6-e053-2995a90a3014SPL set ID 10f25119-9970-46fe-bf36-6fec6064895bRxCUI 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

N442806005301 followed by a unit qualifier and the quantity

Package 42806-0053-01. 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 Jul 26, 2018. 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 078508

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 078508
Product	Strength	Form · route	Labeler	Product NDC
Trandolapriltrandolapril tablets	Trandolapril 1 mg/1	TabletOral	Epic Pharma, LLC	42806-052
Trandolapriltrandolapril tablets	Trandolapril 4 mg/1	TabletOral	Epic Pharma, LLC	42806-054