PREVYMIS
- Product NDC
- 0006-5004
- 11-digit product format
- 000065004
- Labeler code
- 0006
- Product ID
- 0006-5004_282d792e-e2f2-4744-8526-4d18427c55cb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LETERMOVIR
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Merck Sharp & Dohme LLC
- Application
- NDA209940
- Marketing category
- NDA
- Marketing start
- 2017-11-08
- Substance
- LETERMOVIR
- Active strength
- 20 mg/mL
- Pharmacologic classes
- Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytomegalovirus DNA Terminase Complex Inhibitor [EPC], DNA Terminase Complex Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- PREVYMIS
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LETERMOVIR | 20 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1H09Y5WO1F |
| Rxcui | 1988652, 1988657, 1988660, 1988661, 1988666, 1988671, 1988673, 1988675, 2693185, 2693189, 2693191, 2693193 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0006-5004-01 | PREVYMIS | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 28 |
| 0006-5004-02 | PREVYMIS | 24 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 24 | | 28 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0006-5004 | PREVYMIS (LETERMOVIR) TABLET, FILM COATED PREVYMIS (LETERMOVIR) INJECTION, SOLUTION PREVYMIS (LETERMOVIR) PELLET [MERCK SHARP & DOHME LLC] | 27 | Current NDC, Legacy NDC, 2 package rows | 20250215_1b49df80-be4f-47e0-a0b7-123f3e69395b.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 |
|---|
| 0006-5004-01 | 00006500401 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0006-5004-01) / 24 mL in 1 VIAL, SINGLE-DOSE (0006-5004-02) | | 2017-11-08 | 0000-00-00 | No | No | Current |
| 0006-5004-02 | 00006500402 | 24 mL in 1 VIAL, SINGLE-DOSE | 24 ml | | | | | Historical |