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NDC 62559-0860-15 Purified Cortrophin Gel 80 [USP'U]/mL Details
Purified Cortrophin Gel 80 [USP'U]/mL
Purified Cortrophin Gel is a INTRAMUSCULAR; SUBCUTANEOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by ANI Pharmaceuticals, Inc.. The primary component is CORTICOTROPIN.
MedlinePlus Drug Summary
Corticotropin repository injection is used to treat the following conditions: infantile spasms (seizures that usually begin during the first year of life and may be followed by developmental delays) in infants and children younger than 2 years of age; episodes of symptoms in people who have multiple sclerosis (MS; a disease in which the nerves do not function properly and people may experience weakness, numbness, loss of muscle coordination, and problems with vision, speech, and bladder control); episodes of symptoms in people who have rheumatoid arthritis (a condition in which the body attacks its own joints, causing pain, swelling, and loss of function); episodes of symptoms in people who have psoriatic arthritis (a condition that causes joint pain and swelling and scales on the skin); episodes of symptoms in people who have ankylosing spondylitis (a condition in which the body attacks the joints of the spine and other areas, causing pain and joint damage); lupus (a condition in which the body attacks many of its own organs); systemic dermatomyositis (condition that causes muscle weakness and skin rash) or polymyositis (condition that causes muscle weakness but not skin rash); serious allergic reactions that affect the skin including Stevens-Johnson syndrome (a severe allergic reaction that may cause the top layer of skin to blister and shed); serum sickness (a serious allergic reaction that occurs several days after taking certain medications and causes skin rash, fever, joint pain, and other symptoms); allergic reactions or other conditions that cause swelling of the eyes and the area around them; sarcoidosis (condition in which small clumps of immune cells form in various organs such as the lungs, eyes, skin, and heart and interfere with the function of these organs); nephrotic syndrome (a group of symptoms including protein in the urine; low levels of protein in the blood; high levels of certain fats in the blood; and swelling of the arms, hands, feet, and legs). Corticotropin repository injection is in a class of medications called hormones. It treats many conditions by decreasing the activity of the immune system so that it will not cause damage to the organs. There is not enough information to tell how corticotropin repository injection works to treat infantile spasms.
Related Packages: 62559-0860-15Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Corticotropin, Repository Injection
Product Information
NDC | 62559-0860 |
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Product ID | 62559-860_bd6ee278-5424-4ea8-8d6c-bf7207ad16e5 |
Associated GPIs | 30300010004010 |
GCN Sequence Number | 006597 |
GCN Sequence Number Description | corticotropin VIAL 80 UNIT/ML INJECTION |
HIC3 | P1E |
HIC3 Description | ADRENOCORTICOTROPHIC HORMONES |
GCN | 26016 |
HICL Sequence Number | 002830 |
HICL Sequence Number Description | CORTICOTROPIN |
Brand/Generic | Brand |
Proprietary Name | Purified Cortrophin Gel |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Repository Corticotropin |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | INJECTION |
Route | INTRAMUSCULAR; SUBCUTANEOUS |
Active Ingredient Strength | 80 |
Active Ingredient Units | [USP'U]/mL |
Substance Name | CORTICOTROPIN |
Labeler Name | ANI Pharmaceuticals, Inc. |
Pharmaceutical Class | Adrenocorticotropic Hormone [CS], Adrenocorticotropic Hormone [EPC] |
DEA Schedule | n/a |
Marketing Category | NDA |
Application Number | NDA008975 |
Listing Certified Through | 2024-12-31 |
Package
NDC 62559-0860-15 (62559086015)
NDC Package Code | 62559-860-15 |
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Billing NDC | 62559086015 |
Package | 1 VIAL, MULTI-DOSE in 1 CARTON (62559-860-15) / 5 mL in 1 VIAL, MULTI-DOSE |
Marketing Start Date | 2021-10-29 |
NDC Exclude Flag | N |
Pricing Information | N/A |