PREVYMIS
- Product NDC
- 0006-5086
- 11-digit product format
- 000065086
- Labeler code
- 0006
- Product ID
- 0006-5086_282d792e-e2f2-4744-8526-4d18427c55cb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LETERMOVIR
- Dosage form
- PELLET
- Route
- ORAL
- Labeler
- Merck Sharp & Dohme LLC
- Application
- NDA219104
- Marketing category
- NDA
- Marketing start
- 2024-08-30
- Substance
- LETERMOVIR
- Active strength
- 20 mg/1
- 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/1 |
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 |
|---|
| 0006-5086-01 | PREVYMIS | 8 in 1 PACKET | PELLET | 8 | | 28 |
| 0006-5086-01 | PREVYMIS | 30 in 1 CARTON | PELLET | 30 | | 28 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0006-5086 | PREVYMIS (LETERMOVIR) TABLET, FILM COATED PREVYMIS (LETERMOVIR) INJECTION, SOLUTION PREVYMIS (LETERMOVIR) PELLET [MERCK SHARP & DOHME LLC] | 27 | Current 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 | Sample | Exclude flag | Status |
|---|
| 0006-5086-01 | 00006508601 | 30 PACKET in 1 CARTON (0006-5086-01) / 8 PELLET in 1 PACKET | 30 packet | 2024-08-30 | No | No | Current |