Prescription drug · ANDA
Dipyridamole NDC 0641-2569
Dipyridamole 5 mg/mL · Injection · Intravenous · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0641-2569-44 | 0064125694400641256944 | 5 VIAL in 1 CARTON (0641-2569-44) / 10 mL in 1 VIAL (0641-2569-41)Marketed from Oct 18, 1996 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 5 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Hikma Pharmaceuticals USA Inc.NDC labeler code 0641
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074521
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Platelet Aggregation (Physiologic effect)
- Identifiers
- Product ID 0641-2569_4c31b09f-7015-4534-afd6-5cb042792109SPL ID 4c31b09f-7015-4534-afd6-5cb042792109SPL set ID 6093dcd9-82d2-414f-8507-eda22c14f626RxCUI 309953UNII 64ALC7F90CUPC 0306412569440
- 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N400641256944followed by a unit qualifier and the quantityPackage 00641-2569-44. 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 Injection is indicated as an alternative to exercise in thallium myocardial perfusion imaging for the evaluation of coronary artery disease in patients who cannot exercise adequately. In a study of about 1100 patients who underwent coronary arteriography and Dipyridamole Injection assisted thallium imaging, the results of both tests were interpreted blindly and the sensitivity and specificity of the dipyridamole thallium study in predicting the angiographic outcome were calculated. The sensitivity of the dipyridamole test (true positive dipyridamole divided by the total number of patients with positive angiography) was about 85%. The specificity (true negat…
Excerpt only. Read the full label for complete information.
About NDC 0641-2569
- What is NDC 0641-2569?
- 0641-2569 is the product NDC for Dipyridamole, Dipyridamole 5 mg/mL injection, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dipyridamole.
- What is the active ingredient?
- Dipyridamole.
- Who is the labeler?
- Hikma Pharmaceuticals USA Inc., NDC labeler code 0641. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Dipyridamole?
- 15 other product NDCs are listed under this name. See all Dipyridamole NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other 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) |
|---|---|---|---|---|---|
| Dipyridamole | Dipyridamole 50 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4650 | 70518-4650-00 |
| Dipyridamole | Dipyridamole 5 mg/mL | InjectionIntravenous | Henry Schein, Inc. | 0404-9852 | 00404-9852-10 |
| Dipyridamole | Dipyridamole 25 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 0115-1070 | 00115-1070-01 |
| Dipyridamole | Dipyridamole 50 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 0115-1071 | 00115-1071-01 |
| Dipyridamole | Dipyridamole 75 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 0115-1072 | 00115-1072-01 |
| Dipyridamole | Dipyridamole 25 mg/1 | Tablet, Film coatedOral | Oxford Pharmaceuticals, LLC | 69584-181 | 69584-0181-10 |
| Dipyridamole | Dipyridamole 50 mg/1 | Tablet, Film coatedOral | Oxford Pharmaceuticals, LLC | 69584-182 | 69584-0182-10 |
| Dipyridamole | Dipyridamole 75 mg/1 | Tablet, Film coatedOral | Oxford Pharmaceuticals, LLC | 69584-183 | 69584-0183-10 |
| Dipyridamole | Dipyridamole 5 mg/mL | InjectionIntravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1447 | 51662-1447-01 |
| Dipyridamole | Dipyridamole 25 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 65841-662 | 65841-0662-0165841-0662-0565841-0662-10+1 more |
Other NDCs under ANDA 074521
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 5 mg/mL | InjectionIntravenous | Henry Schein, Inc. | 0404-9852 |
| Dipyridamole | Dipyridamole 5 mg/mL | InjectionIntravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1447 |