Prescription drug · ANDA
Clopidogrel bisulfate NDC 50228-124
Clopidogrel bisulfate 75 mg/1 · Tablet, Film coated · Oral · ScieGen Pharmaceuticals Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50228-124-05 | 5022801240550228012405 | 500 TABLET, FILM COATED in 1 BOTTLE (50228-124-05)Marketed from Sep 15, 2015 | |
| 50228-124-10 | 5022801241050228012410 | 1000 TABLET, FILM COATED in 1 BOTTLE (50228-124-10)Marketed from Sep 15, 2015 | |
| 50228-124-30 | 5022801243050228012430 | 30 TABLET, FILM COATED in 1 BOTTLE (50228-124-30)Marketed from Sep 15, 2015 | |
| 50228-124-90 | 5022801249050228012490 | 90 TABLET, FILM COATED in 1 BOTTLE (50228-124-90)Marketed from Sep 15, 2015 |
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 bisulfate
- Generic name (nonproprietary)
- clopidogrel bisulfate
- Active ingredients
- Clopidogrel bisulfate — 75 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- ScieGen Pharmaceuticals IncNDC labeler code 50228
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204165
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C8 Inhibitors (Mechanism)Decreased Platelet Aggregation (Physiologic effect)P2Y12 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 50228-124_0789c766-42ac-6467-e063-6294a90a2c6aSPL ID 0789c766-42ac-6467-e063-6294a90a2c6aSPL set ID d03cfc18-c9e4-41f8-b54d-6a7564c32afbRxCUI 309362, 749196UNII 08I79HTP27UPC 0350228121057, 0350228121309, 0350228124058, 0350228124904, 0350228124102, 0350228124300
- 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
N450228012405followed by a unit qualifier and the quantityPackage 50228-0124-05. 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 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 in pat…
Excerpt only. Read the full label for complete information.
About NDC 50228-124
- What is NDC 50228-124?
- 50228-124 is the product NDC for Clopidogrel bisulfate, Clopidogrel bisulfate 75 mg/1 tablet, film coated, listed with the FDA by ScieGen Pharmaceuticals Inc. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Clopidogrel bisulfate.
- What is the active ingredient?
- Clopidogrel bisulfate.
- Who is the labeler?
- ScieGen Pharmaceuticals Inc, NDC labeler code 50228. 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 bisulfate?
- 21 other product NDCs are listed under this name. See all Clopidogrel bisulfate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Clopidogrel bisulfate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Clopidogrel Bisulfate | Clopidogrel bisulfate 75 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 64980-713 | 64980-0713-0364980-0713-0964980-0713-50 |
| Clopidogrel bisulfate | Clopidogrel bisulfate 75 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4680 | 70518-4680-00 |
| Clopidogrel bisulfate | Clopidogrel bisulfate 75 mg/1 | Tablet, Film coatedOral | Quallent Pharmaceuticals Health LLC | 82009-182 | 82009-0182-05 |
| Clopidogrel bisulfate | Clopidogrel bisulfate 75 mg/1 | Tablet, Film coatedOral | Dr.Reddy's Laboratories Inc | 43598-121 | 43598-0121-0543598-0121-1043598-0121-30+1 more |
| Clopidogrel bisulfate | Clopidogrel bisulfate 300 mg/1 | Tablet, Film coatedOral | Dr.Reddy's Laboratories Inc | 43598-122 | 43598-0122-0543598-0122-3043598-0122-59 |
| Clopidogrel bisulfate | Clopidogrel bisulfate 75 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4110 | 70518-4110-0070518-4110-0170518-4110-02+2 more |
| Clopidogrel bisulfate | Clopidogrel bisulfate 300 mg/1 | Tablet, Film coatedOral | RADHA PHARMACEUTICALS, INC. | 77771-121 | 77771-0121-0577771-0121-3077771-0121-90 |
| Clopidogrel bisulfate | Clopidogrel bisulfate 75 mg/1 | Tablet, Film coatedOral | RADHA PHARMACEUTICALS, INC. | 77771-124 | 77771-0124-1077771-0124-3077771-0124-90 |
| Clopidogrel bisulfate | Clopidogrel bisulfate 75 mg/1 | Tablet, Film coatedOral | Quallent Pharmaceuticals Health LLC | 82009-021 | 82009-0021-05 |
| Clopidogrel bisulfate | Clopidogrel bisulfate 300 mg/1 | Tablet, Film coatedOral | McKesson Corporation dba SKY Packaging | 63739-178 | 63739-0178-30 |
Other NDCs under ANDA 204165
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 | Vensun Pharmaceuticals, Inc. | 42543-713 |
| Clopidogrel | Clopidogrel bisulfate 300 mg/1 | TabletOral | Vensun Pharmaceuticals, Inc. | 42543-714 |
| Clopidogrelclopidogrel bisulfate | Clopidogrel bisulfate 300 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-184 |
| Clopidogrelclopidogrel bisulfate | Clopidogrel bisulfate 300 mg/1 | Tablet, Film coatedOral | Westminster Pharmaceuticals, LLC | 69367-194 |
| Clopidogrelclopidogrel bisulfate | Clopidogrel bisulfate 75 mg/1 | Tablet, Film coatedOral | Westminster Pharmaceuticals, LLC | 69367-200 |
| Clopidogrelclopidogrel bisulfate | Clopidogrel bisulfate 300 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 82804-986 |
| Clopidogrel bisulfate | Clopidogrel bisulfate 75 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8625 |
| Clopidogrel bisulfate | Clopidogrel bisulfate 300 mg/1 | Tablet, Film coatedOral | ScieGen Pharmaceuticals Inc | 50228-121 |
| Clopidogrel bisulfate | Clopidogrel bisulfate 75 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-639 |
| Clopidogrel bisulfate | Clopidogrel bisulfate 75 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-5277 |
| Clopidogrel bisulfate | Clopidogrel bisulfate 75 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals, Inc. | 68788-7700 |
| Clopidogrel bisulfate | Clopidogrel bisulfate 75 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4110 |
| Clopidogrel bisulfate | Clopidogrel bisulfate 75 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1646 |
| Clopidogrel bisulfate | Clopidogrel bisulfate 75 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2212 |
| Clopidogrel bisulfate | Clopidogrel bisulfate 300 mg/1 | Tablet, Film coatedOral | RADHA PHARMACEUTICALS, INC. | 77771-121 |
| Clopidogrel bisulfate | Clopidogrel bisulfate 75 mg/1 | Tablet, Film coatedOral | RADHA PHARMACEUTICALS, INC. | 77771-124 |