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NDC 59467-0318-01 MITIGARE 0.6 mg/1 Details
MITIGARE 0.6 mg/1
MITIGARE is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Hikma Specialty USA Inc.. The primary component is COLCHICINE.
MedlinePlus Drug Summary
Colchicine is used to prevent gout attacks (sudden, severe pain in one or more joints caused by abnormally high levels of a substance called uric acid in the blood) in adults. Colchicine (Colcrys) is also used to relieve the pain of gout attacks when they occur. Colchicine (Colcrys) is also used to treat familial Mediterranean fever (FMF; an inborn condition that causes episodes of fever, pain, and swelling of the stomach area, lungs, and joints) in adults and children 4 years of age and older. Colchicine is not a pain reliever and cannot be used to treat pain that is not caused by gout or FMF. Colchicine is in a class of medications called anti-gout agents. It works by stopping the natural processes that cause swelling and other symptoms of gout and FMF.
Related Packages: 59467-0318-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Colchicine
Product Information
| NDC | 59467-0318 |
|---|---|
| Product ID | 59467-318_8ee07c81-4fb0-40ed-9ea3-6de3b43fd1e1 |
| Associated GPIs | 68000020000120 |
| GCN Sequence Number | 072896 |
| GCN Sequence Number Description | colchicine CAPSULE 0.6 MG ORAL |
| HIC3 | S2A |
| HIC3 Description | COLCHICINE |
| GCN | 37202 |
| HICL Sequence Number | 003717 |
| HICL Sequence Number Description | COLCHICINE |
| Brand/Generic | Brand |
| Proprietary Name | MITIGARE |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Colchicine |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE |
| Route | ORAL |
| Active Ingredient Strength | 0.6 |
| Active Ingredient Units | mg/1 |
| Substance Name | COLCHICINE |
| Labeler Name | Hikma Specialty USA Inc. |
| Pharmaceutical Class | Alkaloid [EPC], Alkaloids [CS] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA204820 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 59467-0318-01 (59467031801)
| NDC Package Code | 59467-318-01 |
|---|---|
| Billing NDC | 59467031801 |
| Package | 100 CAPSULE in 1 BOTTLE (59467-318-01) |
| Marketing Start Date | 2014-10-01 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 6.04659 |
| Pricing Unit | EA |
| Effective Date | 2023-06-21 |
| NDC Description | MITIGARE 0.6 MG CAPSULE |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 2 |
| Classification for Rate Setting | B |
| As of Date | 2024-02-21 |