Colchicine
- Product NDC
- 16714-039
- 11-digit product format
- 167140039
- Labeler code
- 16714
- Product ID
- 16714-039_b510d002-4c8e-4b5e-bc76-c49552e79d45
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Colchicine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Northstar Rx LLC.
- Application
- ANDA211519
- Marketing category
- ANDA
- Marketing start
- 2020-11-10
- Substance
- COLCHICEINE
- Active strength
- .6 mg/1
- 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 |
|---|
| COLCHICEINE | .6 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | HJ30158L57 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 16714-039-01 | Colchicine | 1 in 1 CARTON | TABLET | 1 | | 2 |
| 16714-039-01 | Colchicine | 30 in 1 BOTTLE | TABLET | 30 | | 2 |
| 16714-039-02 | Colchicine | 1 in 1 CARTON | TABLET | 1 | | 2 |
| 16714-039-02 | Colchicine | 100 in 1 BOTTLE | TABLET | 100 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16714-039 | COLCHICINE TABLET [NORTHSTAR RX LLC.] | 2 | Current NDC, Legacy NDC, 4 package rows | 20221211_94bee24f-d846-4344-bc42-b2eae6b433ba.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 16714-039-01 | 16714003901 | 1 BOTTLE in 1 CARTON (16714-039-01) / 30 TABLET in 1 BOTTLE | 1 bottle | 2020-11-10 | 0000-00-00 | No | No | Current |
| 16714-039-02 | 16714003902 | 1 BOTTLE in 1 CARTON (16714-039-02) / 100 TABLET in 1 BOTTLE | 1 bottle | 2020-11-10 | 0000-00-00 | No | No | Current |