Colchicine
- Product NDC
- 62135-789
- 11-digit product format
- 621350789
- Labeler code
- 62135
- Product ID
- 62135-789_459c796b-4b43-354e-e063-6294a90a7dec
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Colchicine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Chartwell RX, LLC
- Application
- ANDA209173
- Marketing category
- ANDA
- Marketing start
- 2023-03-26
- 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 |
|---|
| 62135-789-30 | Colchicine | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 3 |
| 62135-789-90 | Colchicine | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62135-789 | COLCHICINE TABLET, FILM COATED [CHARTWELL RX, LLC] | 2 | Current NDC, 2 package rows | 20241012_16d8e0f4-567d-4de1-ac25-6e2527f1d58e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 62135-789-30 | 62135078930 | 30 TABLET, FILM COATED in 1 BOTTLE (62135-789-30) | 2023-10-27 | No | No | Historical |
| 62135-789-90 | 62135078990 | 90 TABLET, FILM COATED in 1 BOTTLE (62135-789-90) | 2023-10-27 | No | No | Historical |