Arsenic Trioxide
- Product NDC
- 68083-535
- 11-digit product format
- 680830535
- Labeler code
- 68083
- Product ID
- 68083-535_dbad2610-ef0d-4733-a28a-3428ff59f56a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Arsenic Trioxide
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA215059
- Marketing category
- ANDA
- Marketing start
- 2022-04-22
- 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, 1992545 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68083-535-10 | Arsenic Trioxide | 10 in 1 CARTON | INJECTION | 10 | | 8 |
| 68083-535-10 | Arsenic Trioxide | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 10 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-535 | ARSENIC TRIOXIDE INJECTION [GLAND PHARMA LIMITED] | 8 | Current NDC, Legacy NDC, 2 package rows | 20240913_2cb52683-1e74-4831-a771-55a78536cfe5.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68083-535-10 | 68083053510 | 10 VIAL, SINGLE-DOSE in 1 CARTON (68083-535-10) / 10 mL in 1 VIAL, SINGLE-DOSE | 2022-04-22 | 0000-00-00 | No | No | Current |