Prescription drug · ANDA
Dipyridamole NDC 68382-189
Dipyridamole 75 mg/1 · Tablet, Film coated · Oral · Zydus Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68382-189-01 | 68382018901 | 100 TABLET, FILM COATED in 1 BOTTLE (68382-189-01)Marketed from May 22, 2008 | |
| 68382-189-05 | 68382018905 | 500 TABLET, FILM COATED in 1 BOTTLE (68382-189-05)Marketed from May 22, 2008 | |
| 68382-189-10 | 68382018910 | 1000 TABLET, FILM COATED in 1 BOTTLE (68382-189-10)Marketed from May 22, 2008 | |
| 68382-189-77 | 68382018977 | 10 BLISTER PACK in 1 CARTON (68382-189-77) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from May 22, 2008 |
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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040874
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Platelet Aggregation (Physiologic effect)
- Identifiers
- Product ID 68382-189_8b638b19-214a-4a58-a336-656d690130e3SPL ID 8b638b19-214a-4a58-a336-656d690130e3SPL set ID 004bada0-dbf7-4a94-8792-6833d7eeda2bRxCUI 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
N468382018901followed by a unit qualifier and the quantityPackage 68382-0189-01. 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 .
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 040874
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 50 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4650 |
| Dipyridamole | Dipyridamole 50 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 65841-663 |
| Dipyridamole | Dipyridamole 25 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 65841-662 |
| Dipyridamole | Dipyridamole 75 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 65841-664 |
| Dipyridamole | Dipyridamole 25 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals USA Inc. | 68382-187 |
| Dipyridamole | Dipyridamole 50 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals USA Inc. | 68382-188 |