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NDC 00078-0686-15 PROMACTA 50 mg/1 Details
PROMACTA 50 mg/1
PROMACTA is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is ELTROMBOPAG OLAMINE.
MedlinePlus Drug Summary
Eltrombopag is used to increase the number of platelets (cells that help the blood clot) to decrease the risk of bleeding in adults and children 1 year of age and older who have chronic immune thrombocytopenia (ITP; an ongoing condition that may cause unusual bruising or bleeding due to an abnormally low number of platelets in the blood) and who have not been helped or cannot be treated with other treatments, including medications or surgery to remove the spleen. Eltrombopag is also used to increase the number of platelets in people who have hepatitis C (a viral infection that may damage the liver) so that they can begin and continue treatment with interferon (Peginterferon, Pegintron, others) and ribavirin (Rebetol). Eltrombopag is also used in combination with other medications to treat aplastic anemia (condition in which the body does not make enough new blood cells) in adults and children 2 years of age and older. It is also used to treat aplastic anemia in adults who have not been helped with other medications. Eltrombopag is used to increase the number of platelets enough to decrease the risk of bleeding in people with ITP or aplastic anemia, or to allow treatment with interferon and ribavirin in people with hepatitis C. However it is not used to increase the number of platelets to a normal level. Eltrombopag should not be used to treat people who have low numbers of platelets due to conditions other than ITP, hepatitis C, or aplastic anemia. Eltrombopag is in a class of medications called thrombopoietin receptor agonists. It works by causing the cells in the bone marrow to produce more platelets.
Related Packages: 00078-0686-15Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Eltrombopag
Product Information
| NDC | 00078-0686 |
|---|---|
| Product ID | 0078-0686_ca81991b-b7af-4ee8-b1ca-fcc43c38550f |
| Associated GPIs | 82405030100330 |
| GCN Sequence Number | 064631 |
| GCN Sequence Number Description | eltrombopag olamine TABLET 50 MG ORAL |
| HIC3 | N1F |
| HIC3 Description | THROMBOPOIETIN RECEPTOR AGONISTS |
| GCN | 15995 |
| HICL Sequence Number | 035989 |
| HICL Sequence Number Description | ELTROMBOPAG OLAMINE |
| Brand/Generic | Brand |
| Proprietary Name | PROMACTA |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | eltrombopag olamine |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 50 |
| Active Ingredient Units | mg/1 |
| Substance Name | ELTROMBOPAG OLAMINE |
| Labeler Name | Novartis Pharmaceuticals Corporation |
| Pharmaceutical Class | Breast Cancer Resistance Protein Inhibitors [MoA], Increased Megakaryocyte Maturation [PE], Increased Platelet Production [PE], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Thrombopoietin Receptor Agonist [EPC], Thrombopoietin Receptor Ago |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA022291 |
| Listing Certified Through | 2025-12-31 |
Package
NDC 00078-0686-15 (00078068615)
| NDC Package Code | 0078-0686-15 |
|---|---|
| Billing NDC | 00078068615 |
| Package | 30 TABLET, FILM COATED in 1 BOTTLE (0078-0686-15) |
| Marketing Start Date | 2016-04-07 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |