Colchicine
- Product NDC
- 71610-494
- 11-digit product format
- 716100494
- Labeler code
- 71610
- Product ID
- 71610-494_543ae21a-60f3-49e2-8bad-b9ee0f412235
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Colchicine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA210425
- Marketing category
- ANDA
- Marketing start
- 2020-02-05
- Substance
- COLCHICINE
- Active strength
- .6 mg/1
- Pharmacologic classes
- Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Interactions [MoA]
- 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 |
|---|
| 71610-494-03 | Colchicine | 9 in 1 BOTTLE | TABLET, FILM COATED | 9 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71610-494 | COLCHICINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | Current NDC, Legacy NDC, 1 package rows | 20201218_b310c57c-9192-4dc8-b76f-2c1982941caf.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 |
|---|
| 71610-494-03 | 71610049403 | 9 TABLET, FILM COATED in 1 BOTTLE (71610-494-03) | 2020-11-17 | 0000-00-00 | No | No | Current |