Arsenic Trioxide
- Product NDC
- 63323-637
- 11-digit product format
- 633230637
- Labeler code
- 63323
- Product ID
- 63323-637_1ed1c170-ee7f-4f96-98dd-041657d3bdd8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Arsenic Trioxide
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA208231
- Marketing category
- ANDA
- Marketing start
- 2018-08-31
- 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 |
|---|
| 63323-637-03 | Arsenic Trioxide | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 10 | | 5 |
| 63323-637-10 | Arsenic Trioxide | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-637 | ARSENIC TRIOXIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC
] | 4 | Current NDC, Legacy NDC, 2 package rows | 20210618_a482eccd-8837-47ea-904d-2f2c294d10fa.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 |
|---|
| 63323-637-03 | 63323063703 | 10 mL in 1 VIAL, SINGLE-DOSE | 10 ml | | | | | Historical |
| 63323-637-10 | 63323063710 | 10 VIAL, SINGLE-DOSE in 1 CARTON (63323-637-10) / 10 mL in 1 VIAL, SINGLE-DOSE (63323-637-03) | | 2018-08-31 | 0000-00-00 | No | No | Current |