Colchicine
- Product NDC
- 59651-446
- 11-digit product format
- 596510446
- Labeler code
- 59651
- Product ID
- 59651-446_4ccdf563-ca5a-439d-acdd-35067133be31
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Colchicine
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA215463
- Marketing category
- ANDA
- Marketing start
- 2024-04-29
- 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 | 1550940 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59651-446-01 | Colchicine | 100 in 1 BOTTLE | CAPSULE | 100 | | 3 |
| 59651-446-30 | Colchicine | 30 in 1 BOTTLE | CAPSULE | 30 | | 3 |
| 59651-446-99 | Colchicine | 1000 in 1 BOTTLE | CAPSULE | 1000 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59651-446 | COLCHICINE CAPSULE [AUROBINDO PHARMA LIMITED] | 2 | Current NDC, 3 package rows | 20240706_a1ff526f-e89f-4dca-80b6-653d6bdfd895.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 |
|---|
| 59651-446-01 | 59651044601 | 100 CAPSULE in 1 BOTTLE (59651-446-01) | 100 capsule | 2024-04-29 | No | No | Current |
| 59651-446-30 | 59651044630 | 30 CAPSULE in 1 BOTTLE (59651-446-30) | 30 capsule | 2024-07-01 | No | No | Current |
| 59651-446-91 | 59651044691 | 100000 CAPSULE in 1 BAG (59651-446-91) | 100000 capsule | 29-APR-24 | | | Current |
| 59651-446-99 | 59651044699 | 1000 CAPSULE in 1 BOTTLE (59651-446-99) | 1000 capsule | 2024-04-29 | No | No | Current |