Prescription drug · ANDA
Dipyridamole NDC 69584-183
Dipyridamole 75 mg/1 · Tablet, Film coated · Oral · Oxford Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69584-183-10 | 69584018310 | 100 TABLET, FILM COATED in 1 BOTTLE (69584-183-10)Marketed from Apr 15, 2021 |
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)
- Dipyridamole
- Generic name (nonproprietary)
- dipyridamole
- Active ingredients
- Dipyridamole — 75 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Oxford Pharmaceuticals, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040542
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Platelet Aggregation (Physiologic effect)
- Identifiers
- Product ID 69584-183_6cf8d202-17fc-4c56-be33-4d74f6591077SPL ID 6cf8d202-17fc-4c56-be33-4d74f6591077SPL set ID f7ffd78a-e93a-40f4-8193-2d6ab4dafd00RxCUI 197622, 309952, 309955UNII 64ALC7F90C
- Pharmacologic class
- 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
N469584018310followed by a unit qualifier and the quantityPackage 69584-0183-10. 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)
INDICATIONS AND USAGE Dipyridamole tablets are indicated as an adjunct to coumarin anticoagulants in the prevention of postoperative thromboembolic complications of cardiac valve replacement.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 040542
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 |
|---|---|---|---|---|
| Dipyridamole | Dipyridamole 25 mg/1 | Tablet, Film coatedOral | Oxford Pharmaceuticals, LLC | 69584-181 |
| Dipyridamole | Dipyridamole 50 mg/1 | Tablet, Film coatedOral | Oxford Pharmaceuticals, LLC | 69584-182 |