Prescription drug · ANDA
Ramipril NDC 0054-0106
Ramipril 1.25 mg/1 · Capsule · Oral · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0054-0106-25 | 00054010625 | 100 CAPSULE in 1 BOTTLE (0054-0106-25)Marketed from Jun 18, 2008 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Ramipril
- Generic name (nonproprietary)
- ramipril
- Active ingredients
- Ramipril — 1.25 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077900
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin-converting Enzyme Inhibitors (Mechanism)
- Identifiers
- Product ID 0054-0106_8a7f6a6e-70a7-43ce-9f85-e60e237246baSPL ID 8a7f6a6e-70a7-43ce-9f85-e60e237246baSPL set ID 7e9e84f7-ff47-463d-bf47-7a9745960aaeRxCUI 198188, 198189, 261962, 845488UNII L35JN3I7SJUPC 0300540109257, 0300540106256, 0300540108250, 0300540107253
- 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
N400054010625followed by a unit qualifier and the quantityPackage 00054-0106-25. 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)
Ramipril is an angiotensin converting enzyme (ACE) inhibitor indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. It may be used alone or in combination with thiazide diuretics ( 1.1 ). In patients 55 years or older at high risk of developing a major cardiovascular event, ramipril is indicated to reduce the risk of myocardial infarction, stroke, or death from cardiovascular causes ( 1.2 ). Ramipril is indicated in stable patients who have demonstrated clinical signs of congestive heart failure post-myocardial infarction ( 1.3 ). 1.1 Hypertension…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 077900
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 |
|---|---|---|---|---|
| Ramipril | Ramipril 5 mg/1 | CapsuleOral | Hikma Pharmaceuticals USA Inc. | 0054-0108 |
| Ramipril | Ramipril 10 mg/1 | CapsuleOral | Hikma Pharmaceuticals USA Inc. | 0054-0109 |
| Ramipril | Ramipril 1.25 mg/1 | CapsuleOral | Exelan Pharmaceuticals, Inc. | 76282-670 |
| Ramipril | Ramipril 10 mg/1 | CapsuleOral | Exelan Pharmaceuticals, Inc. | 76282-673 |
| Ramipril | Ramipril 2.5 mg/1 | CapsuleOral | Exelan Pharmaceuticals, Inc. | 76282-671 |
| Ramipril | Ramipril 5 mg/1 | CapsuleOral | Exelan Pharmaceuticals, Inc. | 76282-672 |
| Ramipril | Ramipril 2.5 mg/1 | CapsuleOral | Hikma Pharmaceuticals USA Inc. | 0054-0107 |