TPOXX
- Product NDC
- 50072-010
- 11-digit product format
- 500720010
- Labeler code
- 50072
- Product ID
- 50072-010_474526fb-5357-880e-e063-6294a90a3296
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tecovirimat monohydrate
- Dosage form
- INJECTION, SOLUTION, CONCENTRATE
- Route
- INTRAVENOUS
- Labeler
- SIGA Technologies, Inc.
- Application
- NDA214518
- Marketing category
- NDA
- Marketing start
- 2022-05-31
- Substance
- TECOVIRIMAT
- Active strength
- 10 mg/mL
- Pharmacologic classes
- Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Orthopoxvirus VP37 Envelope Wrapping Protein Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- TPOXX
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TECOVIRIMAT | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | F925RR824R, SB96YO2BR8 |
| Rxcui | 2055109, 2055115, 2602126, 2602131 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50072-010-01 | TPOXX | 7 in 1 CARTON | INJECTION, SOLUTION, CONCENTRATE | 7 | | 17 |
| 50072-010-30 | TPOXX | 20 mL in 1 VIAL | INJECTION, SOLUTION, CONCENTRATE | 20 | | 17 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50072-010 | TPOXX (TECOVIRIMAT MONOHYDRATE) INJECTION, SOLUTION, CONCENTRATE TPOXX (TECOVIRIMAT MONOHYDRATE) CAPSULE [SIGA TECHNOLOGIES, INC.] | 16 | Current NDC, Legacy NDC, 2 package rows | 20240718_fce826ab-4d6a-4139-a2ee-a304a913a253.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 |
|---|
| 50072-010-01 | 50072001001 | 7 VIAL in 1 CARTON (50072-010-01) / 20 mL in 1 VIAL (50072-010-30) | 7 vial | 2022-05-31 | 0000-00-00 | No | No | Current |
| 50072-010-30 | 50072001030 | 20 mL in 1 VIAL | 20 ml | | | | | Historical |