Prescription drug · ANDA
Aspirin and Extended-Release Dipyridamole NDC 42291-116
Aspirin 25 mg/1; Dipyridamole 200 mg/1 · Capsule · Oral · AvKARE
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42291-116-60 | 4229101166042291011660 | 60 CAPSULE in 1 BOTTLE (42291-116-60)Marketed from Apr 27, 2017 |
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
- AvKARENDC labeler code 42291
- 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 42291-116_485b7e08-a8d8-f491-e063-6294a90aa415SPL ID 485b7e08-a8d8-f491-e063-6294a90aa415SPL set ID c9a73ec9-e468-46a5-b2c1-99f1f1536585RxCUI 259081UNII R16CO5Y76E, 64ALC7F90CUPC 0342291116603
- 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
N442291011660followed by a unit qualifier and the quantityPackage 42291-0116-60. 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 capsulesis a combination antiplatelet agent 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 42291-116
- What is NDC 42291-116?
- 42291-116 is the product NDC for Aspirin and Extended-Release Dipyridamole, Aspirin 25 mg/1; Dipyridamole 200 mg/1 capsule, listed with the FDA by AvKARE. 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?
- AvKARE, NDC labeler code 42291. 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 | Amneal Pharmaceuticals LLC | 65162-596 | 65162-0596-06 |
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 | Amneal Pharmaceuticals LLC | 65162-596 |