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NDC 60505-4317-00 tolvaptan 15 mg/1 Details
tolvaptan 15 mg/1
tolvaptan is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Apotex Corp.. The primary component is TOLVAPTAN.
MedlinePlus Drug Summary
Tolvaptan (Jynarque) is used to slow the worsening of kidney function in certain patients with autosomal dominant polycystic kidney disease (ADPKD; a certain type of inherited kidney disease). Tolvaptan (Jynarque) is in a class of medications called vasopressin V2 receptor antagonists. It works by increasing the amount of water released from the body as urine and decreases the growth of cysts in the kidneys. Removing fluid from the body and slowing the growth of cysts helps to slow the worsening of kidney function. Tolvaptan is also available as a tablet (Samsca) to treat low blood levels of sodium in people who have heart failure or certain other conditions. This monograph only gives information about tolvaptan tablets (Jynarque) to slow the worsening of kidney function in patients with ADPKD. If you are using this medication to treat low levels of sodium in the blood, read the monograph entitled tolvaptan (low blood sodium).
Related Packages: 60505-4317-00Last Updated: 02/05/2023
MedLinePlus Full Drug Details: Tolvaptan (kidney disease)
Tolvaptan (Samsca) is used to treat hyponatremia (low levels of sodium in the blood) in people who have heart failure (condition in which the heart cannot pump enough blood to all parts of the body), syndrome of inappropriate antidiuretic hormone (SIADH; condition in which the body produces too much of a certain natural substance that causes the body to retain water) or other conditions. Tolvaptan is in a class of medications called vasopressin V2 receptor antagonists. It works by increasing the amount of water released from the body as urine. Removing fluid from the body helps to increase the level of sodium in the blood.
Related Packages: 60505-4317-00Last Updated: 02/05/2023
MedLinePlus Full Drug Details: Tolvaptan (low blood sodium)
Product Information
NDC | 60505-4317 |
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Product ID | 60505-4317_4c608abc-bf94-af08-1ad9-04d18d633ae2 |
Associated GPIs | |
GCN Sequence Number | 065227 |
GCN Sequence Number Description | tolvaptan TABLET 15 MG ORAL |
HIC3 | R1N |
HIC3 Description | ARGININE VASOPRESSIN (AVP) RECEPTOR ANTAGONISTS |
GCN | 24294 |
HICL Sequence Number | 036348 |
HICL Sequence Number Description | TOLVAPTAN |
Brand/Generic | Generic |
Proprietary Name | tolvaptan |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | tolvaptan |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | TABLET |
Route | ORAL |
Active Ingredient Strength | 15 |
Active Ingredient Units | mg/1 |
Substance Name | TOLVAPTAN |
Labeler Name | Apotex Corp. |
Pharmaceutical Class | Vasopressin V2 Receptor Antagonist [EPC], Vasopressin V2 Receptor Antagonists [MoA] |
DEA Schedule | n/a |
Marketing Category | ANDA |
Application Number | ANDA207605 |
Listing Certified Through | 2024-12-31 |
Package
NDC 60505-4317-00 (60505431700)
NDC Package Code | 60505-4317-0 |
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Billing NDC | 60505431700 |
Package | 1 BLISTER PACK in 1 CARTON (60505-4317-0) / 10 TABLET in 1 BLISTER PACK |
Marketing Start Date | 2022-12-14 |
NDC Exclude Flag | N |
Pricing Information | N/A |