Prescription drug · ANDA
Clopidogrel NDC 31722-758
Clopidogrel 75 mg/1 · Tablet · Oral · Camber Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-758-05 | 31722075805 | 500 TABLET in 1 BOTTLE (31722-758-05)Marketed from Aug 4, 2023 | |
| 31722-758-30 | 31722075830 | 30 TABLET in 1 BOTTLE (31722-758-30)Marketed from Aug 4, 2023 | |
| 31722-758-90 | 31722075890 | 90 TABLET in 1 BOTTLE (31722-758-90)Marketed from Aug 4, 2023 |
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 — 75 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Camber Pharmaceuticals, Inc.NDC labeler code 31722
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205345
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C8 Inhibitors (Mechanism)Decreased Platelet Aggregation (Physiologic effect)P2Y12 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 31722-758_04d99965-cea0-8e7d-e063-6394a90ab281SPL ID 04d99965-cea0-8e7d-e063-6394a90ab281SPL set ID b573aefa-e337-478f-97e4-eb8472a7e497RxCUI 309362, 749196UNII A74586SNO7UPC 0331722759304, 0331722758307
- 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
N431722075805followed by a unit qualifier and the quantityPackage 31722-0758-05. 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 tablets are 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 …
Excerpt only. Read the full label for complete information.
About NDC 31722-758
- What is NDC 31722-758?
- 31722-758 is the product NDC for Clopidogrel, Clopidogrel 75 mg/1 tablet, listed with the FDA by Camber Pharmaceuticals, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Clopidogrel.
- What is the active ingredient?
- Clopidogrel.
- Who is the labeler?
- Camber Pharmaceuticals, Inc., NDC labeler code 31722. 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?
- 42 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 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 |
| Clopidogrel | Clopidogrel bisulfate 75 mg/1 | TabletOral | NorthStar RxLLC | 16714-052 | 16714-0052-0116714-0052-0216714-0052-03+3 more |
Other NDCs under ANDA 205345
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 300 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-759 |