Cyanokit
- Product NDC
- 50633-310
- 11-digit product format
- 506330310
- Labeler code
- 50633
- Product ID
- 50633-310_9955075c-c059-4b63-b387-e98ef13e60dc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydroxocobalamin
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- BTG INTERNATIONAL INC.
- Application
- NDA022041
- Marketing category
- NDA
- Marketing start
- 2021-12-15
- Substance
- HYDROXOCOBALAMIN
- Active strength
- 5 g/250mL
- Pharmacologic classes
- Antidote [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cyanokit
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROXOCOBALAMIN | 5 g/250mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | Q40X8H422O |
| Rxcui | 700496, 700499 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50633-310-11 | Cyanokit | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 2 |
| 50633-310-11 | Cyanokit | 250 mL in 1 VIAL, GLASS | INJECTION, POWDER, LYOPHILIZED, | 250 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50633-310 | CYANOKIT (HYDROXOCOBALAMIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BTG INTERNATIONAL INC.] | 2 | Current NDC, Legacy NDC, 2 package rows | 20230504_d56fcc8d-bd64-46ab-b0c0-2124bd745a6b.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 |
|---|
| 50633-310-11 | 50633031011 | 1 VIAL, GLASS in 1 CARTON (50633-310-11) / 250 mL in 1 VIAL, GLASS | 2021-12-15 | 0000-00-00 | No | No | Current |