ARSENIC TRIOXIDE
- Product NDC
- 55150-366
- 11-digit product format
- 551500366
- Labeler code
- 55150
- Product ID
- 55150-366_28fe0658-5c6d-4176-95cc-1b74cf1d8a37
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ARSENIC TRIOXIDE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Eugia US LLC
- Application
- ANDA214011
- Marketing category
- ANDA
- Marketing start
- 2021-10-15
- Substance
- ARSENIC TRIOXIDE
- Active strength
- 2 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 | 2 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | S7V92P67HO |
| Rxcui | 1992545 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55150-366-01 | ARSENIC TRIOXIDE | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 3 |
| 55150-366-01 | ARSENIC TRIOXIDE | 6 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 6 | | 3 |
| 55150-366-10 | ARSENIC TRIOXIDE | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55150-366 | ARSENIC TRIOXIDE INJECTION, SOLUTION [EUGIA US LLC] | 2 | Current NDC, Legacy NDC, 3 package rows | 20241109_2a999752-f350-4eff-97e7-e7106dfa85b5.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 |
|---|
| 55150-366-01 | 55150036601 | 1 in 1 CARTON | | | | | | Historical |
| 55150-366-10 | 55150036610 | 10 CARTON in 1 CARTON (55150-366-10) / 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-366-01) / 6 mL in 1 VIAL, SINGLE-DOSE | 10 carton | 2021-10-15 | 0000-00-00 | No | No | Current |