Prescription drug · ANDA
Clopidogrel Bisulfate NDC 43063-371
Clopidogrel bisulfate 75 mg/1 · Tablet, Film coated · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43063-371-30 | 4306303713043063037130 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-371-30)Marketed from Jul 23, 2012 | |
| 43063-371-60 | 4306303716043063037160 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-371-60)Marketed from Jul 23, 2012 | |
| 43063-371-90 | 4306303719043063037190 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-371-90)Marketed from Jul 23, 2012 |
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
- PD-Rx Pharmaceuticals, Inc.NDC labeler code 43063
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090844
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C8 Inhibitors (Mechanism)Decreased Platelet Aggregation (Physiologic effect)P2Y12 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 43063-371_2f2711fd-44b7-517f-e063-6294a90a0982SPL ID 2f2711fd-44b7-517f-e063-6294a90a0982SPL set ID 03bec9ad-cd22-44d3-9b82-2796157de1d1RxCUI 309362UNII 08I79HTP27UPC 0343063371909
- 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
N443063037130followed by a unit qualifier and the quantityPackage 43063-0371-30. 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 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 rat…
Excerpt only. Read the full label for complete information.
About NDC 43063-371
- What is NDC 43063-371?
- 43063-371 is the product NDC for Clopidogrel Bisulfate, Clopidogrel bisulfate 75 mg/1 tablet, film coated, listed with the FDA by PD-Rx Pharmaceuticals, Inc.. It has 3 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?
- PD-Rx Pharmaceuticals, Inc., NDC labeler code 43063. 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 090844
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 | Tablet, Film coatedOral | Torrent Pharmaceuticals Limited | 13668-141 |