Prescription drug · ANDA
Perindopril Erbumine NDC 65862-286
Perindopril erbumine 2 mg/1 · Tablet · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65862-286-01 | 65862028601 | 100 TABLET in 1 BOTTLE (65862-286-01)Marketed from Nov 10, 2009 |
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)
- Perindopril Erbumine
- Generic name (nonproprietary)
- perindopril erbumine
- Active ingredients
- Perindopril erbumine — 2 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Aurobindo Pharma LimitedNDC labeler code 65862
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 079070
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin-converting Enzyme Inhibitors (Mechanism)
- Identifiers
- Product ID 65862-286_46f1c769-2a77-4526-8303-0abc4a78d53eSPL ID 46f1c769-2a77-4526-8303-0abc4a78d53eSPL set ID 87768fbf-7c63-47da-8925-0316f343d6efRxCUI 854925, 854984, 854988UNII 1964X464OJ
- 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
N465862028601followed by a unit qualifier and the quantityPackage 65862-0286-01. 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)
Perindopril erbumine tablets are indicated for the treatment of patients with essential hypertension. (1.1) Perindopril erbumine tablets are indicated for treatment of patients with stable coronary artery disease to reduce the risk of cardiovascular mortality or nonfatal myocardial infarction. (1.2) 1.1 Hypertension Perindopril erbumine tablets are indicated for the treatment of patients with essential hypertension. Perindopril erbumine tablets may be used alone or given with other classes of antihypertensives, especially thiazide diuretics. 1.2 Stable Coronary Artery Disease Perindopril erbumine tablets are indicated for treatment of patients with stable coronary artery disease to reduce th…
Excerpt only. Read the full label for complete information.
About NDC 65862-286
- What is NDC 65862-286?
- 65862-286 is the product NDC for Perindopril Erbumine, Perindopril erbumine 2 mg/1 tablet, listed with the FDA by Aurobindo Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Perindopril Erbumine.
- What is the active ingredient?
- Perindopril erbumine.
- Who is the labeler?
- Aurobindo Pharma Limited, NDC labeler code 65862. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Perindopril Erbumine?
- 1 other product NDC are listed under this name. See all Perindopril Erbumine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Perindopril Erbumine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Perindopril Erbumine | Perindopril erbumine 4 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-287 | 65862-0287-01 |
Other NDCs under ANDA 079070
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 |
|---|---|---|---|---|
| Perindopril Erbumine | Perindopril erbumine 4 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-287 |
| Perindopril Erbumine | Perindopril erbumine 8 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-288 |