Tembexa
- Product NDC
- 64678-010
- 11-digit product format
- 646780010
- Labeler code
- 64678
- Product ID
- 64678-010_bf0186cb-f9bf-49ea-904b-6f8dd72a2590
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Brincidofovir
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Emergent BioDefense Operations Lansing LLC
- Application
- NDA214461
- Marketing category
- NDA
- Marketing start
- 2022-04-20
- Substance
- BRINCIDOFOVIR
- Active strength
- 100 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Tembexa
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BRINCIDOFOVIR | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6794O900AX |
| Rxcui | 2599535, 2599539, 2599540, 2599541 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 64678-010-01 | Tembexa | 4 in 1 BLISTER PACK | TABLET, FILM COATED | 4 | | 2 |
| 64678-010-02 | Tembexa | 4 in 1 BLISTER PACK | TABLET, FILM COATED | 4 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64678-010 | TEMBEXA (BRINCIDOFOVIR) TABLET, FILM COATED [EMERGENT BIODEFENSE OPERATIONS LANSING LLC] | 1 | Current NDC, 2 package rows | 20230603_209aa94b-c613-4880-ad89-41be83d12c0a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 64678-010-01 | 64678001001 | 4 TABLET, FILM COATED in 1 BLISTER PACK (64678-010-01) | 2022-04-20 | No | No | Historical |
| 64678-010-02 | 64678001002 | 4 TABLET, FILM COATED in 1 BLISTER PACK (64678-010-02) | 2022-04-20 | No | No | Historical |