Prescription drug · ANDA
Trandolapril NDC 63629-8003
Trandolapril 2 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-8003-1 | 6362980030163629800301 | 30 TABLET in 1 BOTTLE (63629-8003-1)Marketed from May 2, 2019 | |
| 63629-8003-2 | 6362980030263629800302 | 90 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
- Labeler
- Bryant Ranch PrepackNDC labeler code 63629
- 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
- 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
N463629800301followed by a unit qualifier and the quantityPackage 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.
About NDC 63629-8003
- What is NDC 63629-8003?
- 63629-8003 is the product NDC for Trandolapril, Trandolapril 2 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. 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?
- Bryant Ranch Prepack, NDC labeler code 63629. 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 | Aurobindo Pharma Limited | 65862-165 | 65862-0165-0165862-0165-99 |
| Trandolapril | Trandolapril 2 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1431 | 71335-1431-0171335-1431-02 |
| Trandolapril | Trandolapril 1 mg/1 | TabletOral | Lupin Pharmaceuticals, Inc. | 68180-566 | 68180-0566-01 |
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 1 mg/1 | TabletOral | Lupin Pharmaceuticals, Inc. | 68180-566 |
| Trandolapril | Trandolapril 2 mg/1 | TabletOral | Lupin Pharmaceuticals, Inc. | 68180-567 |
| Trandolapril | Trandolapril 4 mg/1 | TabletOral | Lupin Pharmaceuticals, Inc. | 68180-568 |