NDC 59467-318
MITIGARE
Colchicine
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.
| Product ID | 59467-318_7dfb5fc7-ded6-46d6-9b98-acffe9065fb4 |
| NDC | 59467-318 |
| Product Type | Human Prescription Drug |
| Proprietary Name | MITIGARE |
| Generic Name | Colchicine |
| Dosage Form | Capsule |
| Route of Administration | ORAL |
| Marketing Start Date | 2014-10-01 |
| Marketing Category | NDA / NDA |
| Application Number | NDA204820 |
| Labeler Name | Hikma Specialty USA Inc. |
| Substance Name | COLCHICINE |
| Active Ingredient Strength | 1 mg/1 |
| Pharm Classes | Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
Packaging
NDC 59467-318-01
100 CAPSULE in 1 BOTTLE (59467-318-01)
| Marketing Start Date | 2014-10-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 59467-318-30 [59467031830]
MITIGARE CAPSULE
| Marketing Category | NDA |
| Application Number | NDA204820 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2018-07-26 |
NDC 59467-318-10 [59467031810]
MITIGARE CAPSULE
| Marketing Category | NDA |
| Application Number | NDA204820 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2014-10-01 |
NDC 59467-318-01 [59467031801]
MITIGARE CAPSULE
| Marketing Category | NDA |
| Application Number | NDA204820 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2014-10-01 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| COLCHICINE | .6 mg/1 |
OpenFDA Data
| SPL SET ID: | cb5f9d85-6b81-49f8-bcd6-17b7bfbc10f2 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
Pharmacological Class
- Cytochrome P450 3A4 Inhibitors [MoA]
- P-Glycoprotein Interactions [MoA]
Medicade Reported Pricing
59467031830 MITIGARE 0.6 MG CAPSULE
Pricing Unit: EA | Drug Type:
59467031810 MITIGARE 0.6 MG CAPSULE
Pricing Unit: EA | Drug Type:
59467031801 MITIGARE 0.6 MG CAPSULE
Pricing Unit: EA | Drug Type:
NDC Crossover Matching brand name "MITIGARE" or generic name "Colchicine"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 59467-318 | MITIGARE | Colchicine |
| 0143-3018 | Colchicine | Colchicine |
| 0254-2008 | Colchicine | Colchicine |
| 0378-1086 | Colchicine | Colchicine |
| 0591-2562 | Colchicine | Colchicine |
| 0904-6732 | Colchicine | Colchicine |
| 0904-7120 | Colchicine | Colchicine |
| 16714-039 | Colchicine | Colchicine |
| 31722-899 | Colchicine | Colchicine |
| 42292-054 | Colchicine | Colchicine |
| 43598-372 | colchicine | colchicine |
| 49884-171 | Colchicine | colchicine |
| 50090-3465 | Colchicine | Colchicine |
| 50268-187 | Colchicine | Colchicine |
| 51407-082 | Colchicine | Colchicine |
| 59651-455 | Colchicine | Colchicine |
| 60687-358 | Colchicine | Colchicine |
| 60687-389 | Colchicine | Colchicine |
| 13310-119 | Colcrys | Colchicine |
| 43353-854 | Colcrys | Colchicine |
| 63187-292 | Colcrys | Colchicine |
Trademark Results [MITIGARE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MITIGARE 86224548 4761409 Live/Registered |
HIKMA PHARMACEUTICALS USA INC. 2014-03-18 |
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