Arsenic trioxide
- Product NDC
- 49315-007
- 11-digit product format
- 493150007
- Labeler code
- 49315
- Product ID
- 49315-007_e80b0973-e6e5-4914-b5f0-4528d7fa7285
- 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
- 2019-09-03
- 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 |
|---|
| 49315-007-01 | Arsenic trioxide | 6 mL in 1 VIAL | INJECTION, SOLUTION | 6 | | 3 |
| 49315-007-10 | 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 |
|---|
| 49315-007 | ARSENIC TRIOXIDE INJECTION, SOLUTION [ZYDUS LIFESCIENCES LIMITED] | 3 | Current NDC, Legacy NDC, 2 package rows | 20221108_2ad7bb19-6152-4158-a179-2388e86a981f.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 |
|---|
| 49315-007-01 | 49315000701 | 6 mL in 1 VIAL | 6 ml | | | | | Historical |
| 49315-007-10 | 49315000710 | 10 VIAL in 1 CARTON (49315-007-10) / 6 mL in 1 VIAL (49315-007-01) | 10 vial | 2019-09-03 | 0000-00-00 | No | No | Current |