Dactinomycin
- Product NDC
- 71288-129
- 11-digit product format
- 712880129
- Labeler code
- 71288
- Product ID
- 71288-129_d9bb02eb-3f9e-4932-bdcd-53b5bd6392b6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dactinomycin
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Meitheal Pharmaceuticals Inc.
- Application
- ANDA213463
- Marketing category
- ANDA
- Marketing start
- 2020-11-13
- 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 |
|---|
| 71288-129-02 | Dactinomycin | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 1 | | 3 |
| 71288-129-02 | Dactinomycin | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71288-129 | DACTINOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20201119_2aaca42a-3b79-4151-a727-83253556a540.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 |
|---|
| 71288-129-02 | 71288012902 | 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-129-02) / 1 mL in 1 VIAL, SINGLE-DOSE | 2020-11-13 | 0000-00-00 | No | No | Current |