Arsenic trioxide
- Product NDC
- 68382-997
- 11-digit product format
- 683820997
- Labeler code
- 68382
- Product ID
- 68382-997_22594609-5946-439a-9cf5-5bf6f83037a1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Arsenic trioxide
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Zydus Pharmaceuticals USA Inc.
- 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 |
|---|
| 68382-997-01 | Arsenic trioxide | 10 mL in 1 VIAL | INJECTION, SOLUTION | 10 | | 8 |
| 68382-997-10 | Arsenic trioxide | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68382-997 | ARSENIC TRIOXIDE INJECTION, SOLUTION [ZYDUS PHARMACEUTICALS USA INC.] | 8 | Current NDC, Legacy NDC, 2 package rows | 20250226_e9d27f88-de82-4379-b143-4b94b3dd8bbe.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 |
|---|
| 68382-997-01 | 68382099701 | 10 mL in 1 VIAL | 10 ml | | | | | Historical |
| 68382-997-10 | 68382099710 | 10 VIAL in 1 CARTON (68382-997-10) / 10 mL in 1 VIAL (68382-997-01) | 10 vial | 2018-11-14 | 0000-00-00 | No | No | Current |