Prescription drug · ANDA
Clopidogrel NDC 65162-414
Clopidogrel bisulfate 75 mg/1 · Tablet · Oral · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65162-414-03 | 6516204140365162041403 | 30 TABLET in 1 BOTTLE (65162-414-03)Marketed from Sep 30, 2013 | |
| 65162-414-09 | 6516204140965162041409 | 90 TABLET in 1 BOTTLE (65162-414-09)Marketed from Sep 30, 2013 | |
| 65162-414-11 | 6516204141165162041411 | 1000 TABLET in 1 BOTTLE (65162-414-11)Marketed from Sep 30, 2013 | |
| 65162-414-50 | 6516204145065162041450 | 500 TABLET in 1 BOTTLE (65162-414-50)Marketed from Sep 30, 2013 |
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)
- Clopidogrel
- Generic name (nonproprietary)
- clopidogrel
- Active ingredients
- Clopidogrel bisulfate — 75 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals LLCNDC labeler code 65162
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203751
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C8 Inhibitors (Mechanism)Decreased Platelet Aggregation (Physiologic effect)P2Y12 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 65162-414_360ed8dd-4f92-46fc-b31b-abe0d75e9bb3SPL ID 360ed8dd-4f92-46fc-b31b-abe0d75e9bb3SPL set ID 0d010775-1160-4b2e-a928-563a02edd191RxCUI 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
N465162041403followed by a unit qualifier and the quantityPackage 65162-0414-03. 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 tablets have been shown to reduce the rate of myocardial infarction (MI) and stroke. (1.1) For patients with ST-elevation myocardial infarction (STEMI), clopidogrel tablets have been shown to reduce the rate of MI and stroke. (1.1) Recent MI, recent stroke, or established peripheral arterial disease. Clopidogrel tablets have been shown to reduce the rate of MI and stroke. (1.2) 1.1 Acute Coronary Syndrome (ACS) Clopidogrel tablets are indicated to reduce the rate of myocardial infar…
Excerpt only. Read the full label for complete information.
About NDC 65162-414
- What is NDC 65162-414?
- 65162-414 is the product NDC for Clopidogrel, Clopidogrel bisulfate 75 mg/1 tablet, listed with the FDA by Amneal Pharmaceuticals LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Clopidogrel.
- What is the active ingredient?
- Clopidogrel bisulfate.
- Who is the labeler?
- Amneal Pharmaceuticals LLC, NDC labeler code 65162. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Clopidogrel?
- 41 other product NDCs are listed under this name. See all Clopidogrel NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Clopidogrel products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Clopidogrelclopidogrel bisulfate | Clopidogrel bisulfate 75 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-4173 | 68788-4173-0368788-4173-0668788-4173-09 |
| Clopidogrelclopidogrel bisulfate | Clopidogrel bisulfate 75 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-2149 | 55154-2149-00 |
| Clopidogrelclopidogrel bisulfate | Clopidogrel bisulfate 75 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4373 | 70518-4373-00 |
| Clopidogrelclopidogrel bisulfate | Clopidogrel bisulfate 75 mg/1 | Tablet, Film coatedOral | Novadoz Pharmaceuticals LLC | 72205-199 | 72205-0199-0172205-0199-0572205-0199-06+2 more |
| Clopidogrelclopidogrel bisulfate | Clopidogrel bisulfate 75 mg/1 | TabletOral | A-S Medication Solutions | 50090-7466 | 50090-7466-0050090-7466-01 |
| Clopidogrelclopidogrel bisulfate | Clopidogrel bisulfate 75 mg/1 | TabletOral | A-S Medication Solutions | 50090-7467 | 50090-7467-00 |
| Clopidogrelclopidogrel bisulfate | Clopidogrel bisulfate 75 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-276 | 67877-0276-0567877-0276-3067877-0276-90 |
| Clopidogrel | Clopidogrel 75 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-758 | 31722-0758-0531722-0758-3031722-0758-90 |
| Clopidogrel | Clopidogrel 300 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-759 | 31722-0759-0531722-0759-30 |
| Clopidogrelclopidogrel bisulfate | Clopidogrel bisulfate 75 mg/1 | Tablet, Film coatedOral | Westminster Pharmaceuticals, LLC | 69367-200 | 69367-0200-05 |