Colchicine
- Product NDC
- 64380-796
- 11-digit product format
- 643800796
- Labeler code
- 64380
- Product ID
- 64380-796_8de9440c-7d34-4837-8bdf-b31d84dff43a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Colchicine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Strides Pharma Science Limited
- Application
- ANDA209173
- Marketing category
- ANDA
- Marketing start
- 2022-09-19
- Substance
- COLCHICINE
- Active strength
- .6 mg/1
- Pharmacologic classes
- Alkaloid [EPC], Alkaloids [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Colchicine
- Listing expiration
- 2027-12-31
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 |
|---|
| 64380-796-04 | Colchicine | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 9 |
| 64380-796-06 | Colchicine | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64380-796 | COLCHICINE TABLET, FILM COATED [STRIDES PHARMA SCIENCE LIMITED] | 8 | Current NDC, Legacy NDC, 2 package rows | 20230219_50b9c910-49a3-4a57-80f5-dc36c09da4df.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 64380-796-04 | 64380079604 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64380-796-04) | 2022-09-19 | 0000-00-00 | No | No | Current |
| 64380-796-06 | 64380079606 | 100 TABLET, FILM COATED in 1 BOTTLE (64380-796-06) | 2022-09-19 | 0000-00-00 | No | No | Current |