Prescription drug · NDA
Effient (Prasugrel hydrochloride) NDC 0713-0881
Prasugrel hydrochloride 5 mg/1 · Tablet, Coated · Oral · Cosette Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0713-0881-30 | 00713088130 | 30 TABLET, COATED in 1 BOTTLE (0713-0881-30)Marketed from Sep 1, 2022 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Effient
- Generic name (nonproprietary)
- prasugrel hydrochloride
- Active ingredients
- Prasugrel hydrochloride — 5 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- Cosette Pharmaceuticals, Inc.NDC labeler code 0713
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022307
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Platelet Aggregation (Physiologic effect)P2Y12 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 0713-0881_e8172297-af81-4c37-e053-2995a90ad4e5SPL ID e8172297-af81-4c37-e053-2995a90ad4e5SPL set ID 69ea2d58-5353-4222-b61f-cab976fa7e5eRxCUI 855812, 855816, 855818, 855820UNII G89JQ59I13UPC 0307130882309, 0307130881302
- 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
N400713088130followed by a unit qualifier and the quantityPackage 00713-0881-30. 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)
Effient is a P2Y 12 platelet inhibitor indicated for the reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndrome who are to be managed with percutaneous coronary intervention (PCI) as follows: Patients with unstable angina or non-ST-elevation myocardial infarction (NSTEMI) ( 1.1 ). Patients with ST-elevation myocardial infarction (STEMI) when managed with either primary or delayed PCI ( 1.1 ). 1.1 Acute Coronary Syndrome Effient ® is indicated to reduce the rate of thrombotic CV events (including stent thrombosis) in patients with acute coronary syndrome (ACS) who are to be managed with percutaneous coronary intervention (PCI) as fo…
Excerpt only. Read the full label for complete information.
About NDC 0713-0881
- What is NDC 0713-0881?
- 0713-0881 is the product NDC for Effient (prasugrel hydrochloride), Prasugrel hydrochloride 5 mg/1 tablet, coated, listed with the FDA by Cosette Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Effient (Prasugrel Hydrochloride).
- What is the active ingredient?
- Prasugrel hydrochloride.
- Who is the labeler?
- Cosette Pharmaceuticals, Inc., NDC labeler code 0713. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Effient?
- 1 other product NDC are listed under this name. See all Effient NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Effient products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Effientprasugrel hydrochloride | Prasugrel hydrochloride 10 mg/1 | Tablet, CoatedOral | Cosette Pharmaceuticals, Inc. | 0713-0882 | 00713-0882-30 |
Other NDCs under NDA 022307
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 |
|---|---|---|---|---|
| Effientprasugrel hydrochloride | Prasugrel hydrochloride 10 mg/1 | Tablet, CoatedOral | Cosette Pharmaceuticals, Inc. | 0713-0882 |