Colcrys
- Product NDC
- 43353-854
- 11-digit product format
- 433530854
- Labeler code
- 43353
- Product ID
- 43353-854_9d38ee67-c179-48c6-8280-075fd7919069
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Colchicine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- NDA022352
- Marketing category
- NDA
- Marketing start
- 2009-09-01
- Marketing end
- 0000-00-00
- Substance
- COLCHICINE
- Active strength
- 1 mg/1
- Pharmacologic classes
- Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43353-854-09 | Colcrys | 9000 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 9000 | | 2 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Colchicine | ACTIVE INGREDIENT | SML2Y3J35T | COLCRYS (COLCHICINE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| Colchicine | ACTIVE MOIETY | SML2Y3J35T | COLCRYS (COLCHICINE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| carnauba wax | INACTIVE INGREDIENT | R12CBM0EIZ | COLCRYS (COLCHICINE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| cellulose, microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | COLCRYS (COLCHICINE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| FD&C blue no. 2 | INACTIVE INGREDIENT | L06K8R7DQK | COLCRYS (COLCHICINE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| FD&C red no. 40 | INACTIVE INGREDIENT | WZB9127XOA | COLCRYS (COLCHICINE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | COLCRYS (COLCHICINE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| lactose monohydrate | INACTIVE INGREDIENT | EWQ57Q8I5X | COLCRYS (COLCHICINE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | COLCRYS (COLCHICINE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| polydextrose | INACTIVE INGREDIENT | VH2XOU12IE | COLCRYS (COLCHICINE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| polyethylene glycols | INACTIVE INGREDIENT | 3WJQ0SDW1A | COLCRYS (COLCHICINE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| sodium starch glycolate type A potato | INACTIVE INGREDIENT | 5856J3G2A2 | COLCRYS (COLCHICINE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| starch, corn | INACTIVE INGREDIENT | O8232NY3SJ | COLCRYS (COLCHICINE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | COLCRYS (COLCHICINE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| triacetin | INACTIVE INGREDIENT | XHX3C3X673 | COLCRYS (COLCHICINE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43353-854 | COLCRYS (COLCHICINE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | Legacy NDC, 1 package rows | 20191231_a80036fe-3016-4541-aa42-6c06cf37ae55.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 |
|---|
| 43353-854-09 | 43353085409 | 9000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-854-09) | 2013-07-02 | 0000-00-00 | No | No | Current |