ARSENIC TRIOXIDE
- Product NDC
- 50742-438
- 11-digit product format
- 507420438
- Labeler code
- 50742
- Product ID
- 50742-438_b3030683-7cb9-4143-abbd-d3894313e83d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- arsenic trioxide
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Ingenus Pharmaceuticals, LLC
- Application
- ANDA209315
- Marketing category
- ANDA
- Marketing start
- 2018-11-15
- Substance
- ARSENIC TRIOXIDE
- Active strength
- 1 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ARSENIC TRIOXIDE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ARSENIC TRIOXIDE | 1 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | S7V92P67HO |
| Rxcui | 829926 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50742-438-10 | ARSENIC TRIOXIDE | 1 in 1 CARTON | INJECTION | 1 | | 11 |
| 50742-438-10 | ARSENIC TRIOXIDE | 10 mL in 1 VIAL, GLASS | INJECTION | 10 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50742-438 | ARSENIC TRIOXIDE INJECTION [INGENUS PHARMACEUTICALS, LLC] | 10 | Current NDC, Legacy NDC, 2 package rows | 20221129_c99b01b4-67ff-4793-8375-fe3a21c6c9be.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 |
|---|
| 50742-438-10 | 50742043810 | 1 VIAL, GLASS in 1 CARTON (50742-438-10) / 10 mL in 1 VIAL, GLASS | 2018-11-15 | 0000-00-00 | No | No | Current |