NDC codes

FDA NDC Directory
Product NDC (as listed)63629-8003Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63629-8003Add 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 NDC11-digit (billing)PackageCopy
63629-8003-16362980030130 TABLET in 1 BOTTLE (63629-8003-1)Marketed from May 2, 2019
63629-8003-26362980030290 TABLET in 1 BOTTLE (63629-8003-2)Marketed from Feb 9, 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)
Trandolapril
Generic name (nonproprietary)
trandolapril
Active ingredients
Trandolapril — 2 mg/1
Dosage form
Tablet
Route
Oral
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 63629-8003_6393820e-daaa-41b2-b2cb-5fe6c433a854SPL ID 6393820e-daaa-41b2-b2cb-5fe6c433a854SPL set ID 514f53e6-ff6b-4d02-9db9-2575b15aa5f0RxCUI 199351UNII 1T0N3G9CRC

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

N463629800301 followed by a unit qualifier and the quantity

Package 63629-8003-01. 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 077522

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

FDA NDC Directory listings under ANDA 077522
ProductStrengthForm · routeLabelerProduct NDC
TrandolaprilTrandolapril 1 mg/1TabletOralLupin Pharmaceuticals, Inc.68180-566
TrandolaprilTrandolapril 2 mg/1TabletOralLupin Pharmaceuticals, Inc.68180-567
TrandolaprilTrandolapril 4 mg/1TabletOralLupin Pharmaceuticals, Inc.68180-568

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in