Prescription drug · ANDA
Clopidogrel NDC 50090-5781
Clopidogrel bisulfate 75 mg/1 · Tablet · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-5781-0 | 50090578100 | 30 TABLET in 1 BOTTLE (50090-5781-0)Marketed from Oct 8, 2021 | |
| 50090-5781-1 | 50090578101 | 90 TABLET in 1 BOTTLE (50090-5781-1)Marketed from Oct 8, 2021 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Clopidogrel
- Generic name (nonproprietary)
- clopidogrel
- Active ingredients
- Clopidogrel bisulfate — 75 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- A-S Medication Solutions
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202928
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C8 Inhibitors (Mechanism)Decreased Platelet Aggregation (Physiologic effect)P2Y12 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 50090-5781_4a4c0017-ff4f-4475-8257-c0994ad0e332SPL ID 4a4c0017-ff4f-4475-8257-c0994ad0e332SPL set ID 02f0eaf8-0fc2-425d-8259-cef00156e25dRxCUI 309362UNII 08I79HTP27
- Pharmacologic class
- P2Y12 Platelet 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
N450090578100followed by a unit qualifier and the quantityPackage 50090-5781-00. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Clopidogrel is a P2Y 12 platelet inhibitor indicated for: • Acute coronary syndrome -For patients with non-ST-segment elevation ACS (unstable angina [UA]/non-ST-elevation myocardial infarction [NSTEMI]), clopidogrel has been shown to reduce the rate of myocardial infarction (MI) and stroke. ( 1.1 ) - For patients with ST-elevation myocardial infarction (STEMI), clopidogrel has been shown to reduce the rate of MI and stroke. ( 1.1 ) • Recent MI, recent stroke, or established peripheral arterial disease. Clopidogrel has been shown to reduce the rate of MI and stroke. ( 1.2 ) 1.1 Acute Coronary Syndrome (ACS) • Clopidogrel is indicated to reduce the rate of myocardial infarction (MI) and stroke…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 202928
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 |
|---|---|---|---|---|
| Clopidogrel | Clopidogrel bisulfate 75 mg/1 | TabletOral | NorthStar RxLLC | 16714-052 |
| Clopidogrel | Clopidogrel bisulfate 75 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0581 |
| Clopidogrel | Clopidogrel bisulfate 75 mg/1 | TabletOral | Redpharm Drug | 67296-2266 |
| Clopidogrel | Clopidogrel bisulfate 75 mg/1 | TabletOral | A-S Medication Solutions | 50090-6568 |
| Clopidogrel | Clopidogrel bisulfate 75 mg/1 | TabletOral | A-S Medication Solutions | 50090-6567 |
| Clopidogrel | Clopidogrel bisulfate 75 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-060 |