DACTINOMYCIN
- Product NDC
- 55150-928
- 11-digit product format
- 551500928
- Labeler code
- 55150
- Product ID
- 55150-928_f7cacd7d-479f-4a00-8db6-f11ad039b314
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DACTINOMYCIN
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Eugia US LLC
- Application
- ANDA203385
- Marketing category
- ANDA
- Marketing start
- 2021-03-15
- Substance
- DACTINOMYCIN
- Active strength
- .5 mg/mL
- Pharmacologic classes
- Actinomycin [EPC], Nucleic Acid Synthesis Inhibitors [MoA], Protein Synthesis Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- DACTINOMYCIN
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DACTINOMYCIN | .5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1CC1JFE158 |
| Rxcui | 239179 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55150-928-02 | DACTINOMYCIN | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 1 | | 2 |
| 55150-928-02 | DACTINOMYCIN | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55150-928 | DACTINOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [EUGIA US LLC] | 2 | Current NDC, Legacy NDC, 2 package rows | 20240619_5da55538-2602-4704-a9da-603c9f7ff7dc.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 |
|---|
| 55150-928-02 | 55150092802 | 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-928-02) / 1 mL in 1 VIAL, SINGLE-DOSE | 2021-03-15 | 0000-00-00 | No | No | Current |