Arsenic trioxide
- Product NDC
- 49315-005
- 11-digit product format
- 493150005
- Labeler code
- 49315
- Product ID
- 49315-005_a8f76ffc-24cf-4d5b-9bd2-1ace0c66eec5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Arsenic trioxide
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Zydus Lifesciences Limited
- Application
- ANDA206228
- Marketing category
- ANDA
- Marketing start
- 2018-11-14
- 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 |
|---|
| 49315-005-01 | Arsenic trioxide | 10 mL in 1 VIAL | INJECTION, SOLUTION | 10 | | 3 |
| 49315-005-10 | 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 |
|---|
| 49315-005 | ARSENIC TRIOXIDE INJECTION, SOLUTION [ZYDUS LIFESCIENCES LIMITED] | 3 | Current NDC, Legacy NDC, 2 package rows | 20221108_25e8295c-b5d9-4322-a093-d907ab1d1d35.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 |
|---|
| 49315-005-01 | 49315000501 | 10 mL in 1 VIAL | 10 ml | | | | | Historical |
| 49315-005-10 | 49315000510 | 10 VIAL in 1 CARTON (49315-005-10) / 10 mL in 1 VIAL (49315-005-01) | 10 vial | 2018-11-14 | 0000-00-00 | No | No | Current |