ARSENIC TRIOXIDE
- Product NDC
- 81607-005
- 11-digit product format
- 816070005
- Labeler code
- 81607
- Product ID
- 81607-005_96a1d1a1-1b78-4199-9770-08093ef03b39
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- arsenic trioxide
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Orbicular Pharmaceutical Technologies Private Limited
- Application
- ANDA217413
- Marketing category
- ANDA
- Marketing start
- 2023-05-31
- 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, 1992545 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 81607-005-10 | ARSENIC TRIOXIDE | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 10 | | 1 |
| 81607-005-11 | ARSENIC TRIOXIDE | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 81607-005 | ARSENIC TRIOXIDE INJECTION, SOLUTION [ORBICULAR PHARMACEUTICAL TECHNOLOGIES PRIVATE LIMITED] | 1 | Current NDC, 2 package rows | 20230531_3b007d59-99ad-409f-a71e-7f4e7d6f6b12.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 81607-005-10 | 81607000510 | 10 mL in 1 VIAL, SINGLE-DOSE | 10 ml | | | | Historical |
| 81607-005-11 | 81607000511 | 10 VIAL, SINGLE-DOSE in 1 CARTON (81607-005-11) / 10 mL in 1 VIAL, SINGLE-DOSE (81607-005-10) | | 2023-05-31 | No | No | Current |