Gloperba
- Product NDC
- 69557-222
- 11-digit product format
- 695570222
- Labeler code
- 69557
- Product ID
- 69557-222_25e07ab6-c140-6aae-e063-6394a90ac06e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Colchicine
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Scilex Pharmaceuticals Inc.
- Application
- NDA210942
- Marketing category
- NDA
- Marketing start
- 2024-01-31
- Substance
- COLCHICINE
- Active strength
- .6 mg/5mL
- 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
- Gloperba
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| COLCHICINE | .6 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | SML2Y3J35T |
| Rxcui | 2118892, 2180558 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69557-222-01 | Gloperba | 150 mL in 1 BOTTLE | SOLUTION | 150 | | 3 |
| 69557-222-01 | Gloperba | 1 in 1 CARTON | SOLUTION | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69557-222 | GLOPERBA (COLCHICINE) SOLUTION [SCILEX PHARMACEUTICALS INC.] | 3 | Current NDC, 2 package rows | 20241105_467cd83f-d695-4040-9434-10e80b4271da.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 |
|---|
| 69557-222-01 | 69557022201 | 1 BOTTLE in 1 CARTON (69557-222-01) / 150 mL in 1 BOTTLE | 1 bottle | 2024-01-31 | No | No | Historical |