MITIGARE
- Product NDC
- 59467-318
- 11-digit product format
- 594670318
- Labeler code
- 59467
- Product ID
- 59467-318_14dc4aa3-a989-41f6-9dd4-86f5490dc152
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Colchicine
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Hikma Specialty USA Inc.
- Application
- NDA204820
- Marketing category
- NDA
- Marketing start
- 2014-10-01
- Substance
- COLCHICINE
- Active strength
- .6 mg/1
- Pharmacologic classes
- Alkaloid [EPC], Alkaloids [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- MITIGARE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| COLCHICINE | .6 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | SML2Y3J35T |
| Rxcui | 1550940, 1550946 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59467-318-01 | MITIGARE | 100 in 1 BOTTLE | CAPSULE | 100 | | 18 |
| 59467-318-10 | MITIGARE | 1000 in 1 BOTTLE | CAPSULE | 1000 | | 18 |
| 59467-318-30 | MITIGARE | 30 in 1 BOTTLE | CAPSULE | 30 | | 18 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59467-318 | MITIGARE (COLCHICINE) CAPSULE [HIKMA SPECIALTY USA INC.] | 18 | Current NDC, Legacy NDC, 3 package rows | 20240523_cb5f9d85-6b81-49f8-bcd6-17b7bfbc10f2.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 59467-318-01 | 59467031801 | 100 CAPSULE in 1 BOTTLE (59467-318-01) | 100 capsule | 2014-10-01 | 0000-00-00 | No | No | Current |
| 59467-318-10 | 59467031810 | 1000 CAPSULE in 1 BOTTLE (59467-318-10) | 1000 capsule | 2014-10-01 | 0000-00-00 | No | No | Current |
| 59467-318-30 | 59467031830 | 30 CAPSULE in 1 BOTTLE (59467-318-30) | 30 capsule | 2018-07-26 | 0000-00-00 | No | No | Current |