Colchicine
- Product NDC
- 0378-1086
- 11-digit product format
- 003781086
- Labeler code
- 0378
- Product ID
- 0378-1086_9ba74921-d6b7-40a8-aa1e-d7431574a137
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Colchicine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA209470
- Marketing category
- ANDA
- Marketing start
- 2019-11-25
- 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
- Colchicine
- 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 | 197541 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0378-1086-01 | Colchicine | 100 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 100 | | 6 |
| 0378-1086-93 | Colchicine | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-1086 | COLCHICINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 6 | Current NDC, Legacy NDC, 2 package rows | 20240618_85acf34c-06c6-40ea-95f4-060d5de99277.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0378-1086-01 | 00378108601 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1086-01) | 2019-11-25 | 0000-00-00 | No | No | Current |
| 0378-1086-93 | 00378108693 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1086-93) | 2019-11-25 | 0000-00-00 | No | No | Current |