Dactinomycin
- Product NDC
- 42658-008
- 11-digit product format
- 426580008
- Labeler code
- 42658
- Product ID
- 42658-008_1b25a447-d782-5889-e063-6294a90aebe5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- dactinomycin
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Hisun Pharmaceuticals USA, Inc.
- Application
- ANDA207232
- Marketing category
- ANDA
- Marketing start
- 2024-05-08
- Substance
- DACTINOMYCIN
- Active strength
- .5 mg/1
- 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/1 |
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 |
|---|
| 42658-008-01 | Dactinomycin | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 8 |
| 42658-008-01 | Dactinomycin | 1 in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 1 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42658-008 | DACTINOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HISUN PHARMACEUTICALS USA, INC.] | 8 | Current NDC, Legacy NDC, 2 package rows | 20240619_95d5c152-aa00-41e6-83e8-8df374a56447.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 42658-008-01 | 42658000801 | 1 VIAL in 1 CARTON (42658-008-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL | 1 vial | 2024-05-08 | 0000-00-00 | No | No | Current |