Colchicine
- Product NDC
- 0254-0460
- 11-digit product format
- 002540460
- Labeler code
- 0254
- Product ID
- 0254-0460_976af5c9-3fa5-4a35-b849-6cc69b892c1f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Colchicine
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Par Health USA, LLC
- Application
- ANDA208678
- Marketing category
- ANDA
- Marketing start
- 2023-11-01
- Substance
- COLCHICINE
- Active strength
- .6 mg/1
- Pharmacologic classes
- Alkaloid [EPC], Alkaloids [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Colchicine
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| COLCHICINE | .6 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | SML2Y3J35T |
| Rxcui | 1550940 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0254-0460-01 | Colchicine | 100 in 1 BOTTLE | CAPSULE | 100 | | 23 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0254-0460 | COLCHICINE CAPSULE [ENDO USA, INC.] | 19 | Current NDC, 1 package rows | 20250112_eb509994-6ecc-4599-b87a-98495fef6129.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0254-0460-01 | 00254046001 | 100 CAPSULE in 1 BOTTLE (0254-0460-01) | 100 capsule | 2023-11-01 | No | No | Historical |