IDVYNSO
- Product NDC
- 0006-5092
- 11-digit product format
- 000065092
- Labeler code
- 0006
- Product ID
- 0006-5092_28037738-bcd2-49cd-b6f3-429f0b4a287c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Doravirine, Islatravir
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Merck Sharp & Dohme LLC
- Application
- NDA216964
- Marketing category
- NDA
- Marketing start
- 2026-04-23
- Substance
- DORAVIRINE; ISLATRAVIR ANHYDROUS
- Active strength
- 100; .25 mg/1; mg/1
- Pharmacologic classes
- Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase 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
- IDVYNSO
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DORAVIRINE | 100 mg/1 |
| ISLATRAVIR ANHYDROUS | .25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 913P6LK81M, QPQ082R25D |
| Rxcui | 2741694, 2741700 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0006-5092-01 | IDVYNSO | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 2 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0006-5092-01 | 00006509201 | 30 TABLET, FILM COATED in 1 BOTTLE (0006-5092-01) | 2026-04-23 | No | No | Current |
| 0006-5092-59 | 00006509259 | 14 TABLET, FILM COATED in 1 BOTTLE (0006-5092-59) | 2026-04-23 | 1 | | Current |