Tembexa
- Product NDC
- 64678-012
- 11-digit product format
- 646780012
- Labeler code
- 64678
- Product ID
- 64678-012_8ce2edcc-3c73-4a58-b96e-c7ba5408d3c9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Brincidofovir
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Emergent BioDefense Operations Lansing LLC
- Application
- NDA214460
- Marketing category
- NDA
- Marketing start
- 2022-04-20
- Substance
- BRINCIDOFOVIR
- Active strength
- 10 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
- Tembexa
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BRINCIDOFOVIR | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6794O900AX |
| Rxcui | 2599525, 2599531 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64678-012 | TEMBEXA (BRINCIDOFOVIR) SUSPENSION [EMERGENT BIODEFENSE OPERATIONS LANSING LLC] | 1 | Current NDC, 6 package rows | 20230603_0784838e-00bd-4b14-9b7e-653b7fbb7eea.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 |
|---|
| 64678-012-01 | 64678001201 | 65 mL in 1 BOTTLE (64678-012-01) | 65 ml | 2022-04-20 | No | No | Current |
| 64678-012-02 | 64678001202 | 65 mL in 1 BOTTLE (64678-012-02) | 65 ml | 2022-04-20 | No | No | Current |
| 64678-012-03 | 64678001203 | 1 BOTTLE in 1 CARTON (64678-012-03) / 45 mL in 1 BOTTLE | 1 bottle | 2025-07-23 | No | No | Current |
| 64678-012-04 | 64678001204 | 1 BOTTLE in 1 CARTON (64678-012-04) / 45 mL in 1 BOTTLE | 1 bottle | 2025-07-23 | No | No | Current |