Zycubo
- Product NDC
- 42358-329
- 11-digit product format
- 423580329
- Labeler code
- 42358
- Product ID
- 42358-329_bfd40890-37a6-4847-9b2d-6e6966b6af01
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- copper histidinate
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Sentynl Therapeutics, Inc.
- Application
- NDA211241
- Marketing category
- NDA
- Marketing start
- 2026-01-12
- Substance
- COPPER HISTIDINATE
- Active strength
- 2.9 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Zycubo
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| COPPER HISTIDINATE | 2.9 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9078K3MO9U |
| Rxcui | 2732219, 2732224 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42358-329-01 | Zycubo | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 2 |
| 42358-329-01 | Zycubo | 1 in 1 VIAL, GLASS | INJECTION, POWDER, LYOPHILIZED, | 1 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 42358-329-01 | 42358032901 | 1 VIAL, GLASS in 1 CARTON (42358-329-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS | 2026-01-26 | No | No | Historical |