Prescription drug · ANDA
Aspirin and Extended-Release Dipyridamole NDC 65162-596
Aspirin 25 mg/1; Dipyridamole 200 mg/1 · Capsule · Oral · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65162-596-06 | 6516205960665162059606 | 60 CAPSULE in 1 BOTTLE (65162-596-06)Marketed from Mar 28, 2016 |
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)
- Aspirin and Extended-Release Dipyridamole
- Generic name (nonproprietary)
- aspirin and extended-release dipyridamole
- Active ingredients
- Aspirin — 25 mg/1Dipyridamole — 200 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals LLCNDC labeler code 65162
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206392
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Platelet Aggregation (Physiologic effect)Decreased Platelet Aggregation (Physiologic effect)Decreased Prostaglandin Production (Physiologic effect)
- Identifiers
- Product ID 65162-596_bf81f508-2def-4916-a2f1-0f73f473be3fSPL ID bf81f508-2def-4916-a2f1-0f73f473be3fSPL set ID 369cb8a3-e1e4-4150-859d-4f788436ddcaRxCUI 259081UNII R16CO5Y76E, 64ALC7F90CUPC 0365162596069
- Pharmacologic class
- Nonsteroidal Anti-inflammatory Drug; Platelet Aggregation 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
N465162059606followed by a unit qualifier and the quantityPackage 65162-0596-06. 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 .
Indications (excerpt from the label)
Aspirin and extended-release dipyridamole capsules are indicated to reduce the risk of stroke in patients who have had transient ischemia of the brain or completed ischemic stroke due to thrombosis. Aspirin and extended-release dipyridamole capsules are a combination of aspirin and dipyridamole, antiplatelet agents, indicated to reduce the risk of stroke in patients who have had transient ischemia of the brain or completed ischemic stroke due to thrombosis. (1)
Excerpt only. Read the full label for complete information.
About NDC 65162-596
- What is NDC 65162-596?
- 65162-596 is the product NDC for Aspirin and Extended-Release Dipyridamole, Aspirin 25 mg/1; Dipyridamole 200 mg/1 capsule, listed with the FDA by Amneal Pharmaceuticals LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Aspirin and Extended-Release Dipyridamole.
- What is the active ingredient?
- Aspirin, Dipyridamole.
- Who is the labeler?
- Amneal Pharmaceuticals LLC, NDC labeler code 65162. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Aspirin and Extended-Release Dipyridamole?
- 3 other product NDCs are listed under this name. See all Aspirin and Extended-Release Dipyridamole NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Aspirin and Extended-Release Dipyridamole products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Aspirin And Extended-Release Dipyridamole | Aspirin 25 mg/1; Dipyridamole 200 mg/1 | Capsule, Extended releaseOral | Micro Labs Limited | 42571-274 | 42571-0274-60 |
| Aspirin And Extended-Release Dipyridamole | Aspirin 25 mg/1; Dipyridamole 200 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 63629-5045 | 63629-5045-01 |
| Aspirin and Extended-Release Dipyridamole | Aspirin 25 mg/1; Dipyridamole 200 mg/1 | CapsuleOral | AvKARE | 42291-116 | 42291-0116-60 |
Other NDCs under ANDA 206392
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 |
|---|---|---|---|---|
| Aspirin and Extended-Release Dipyridamole | Aspirin 25 mg/1; Dipyridamole 200 mg/1 | CapsuleOral | AvKARE | 42291-116 |