DELSTRIGO
- Product NDC
- 0006-5007
- 11-digit product format
- 000065007
- Labeler code
- 0006
- Product ID
- 0006-5007_237e7245-b6e8-40df-8d66-4bb122136834
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- doravirine, lamivudine, and tenofovir disoproxil fumarate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Merck Sharp & Dohme LLC
- Application
- NDA210807
- Marketing category
- NDA
- Marketing start
- 2018-07-20
- Substance
- DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
- Active strength
- 100; 300; 300 mg/1; mg/1; mg/1
- Pharmacologic classes
- Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- DELSTRIGO
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DORAVIRINE | 100 mg/1 |
| LAMIVUDINE | 300 mg/1 |
| TENOFOVIR DISOPROXIL FUMARATE | 300 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 913P6LK81M, 2T8Q726O95, OTT9J7900I |
| Rxcui | 2055813, 2055815 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0006-5007-01 | DELSTRIGO | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 23 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0006-5007 | DELSTRIGO (DORAVIRINE, LAMIVUDINE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [MERCK SHARP & DOHME LLC] | 20 | Current NDC, Legacy NDC, 1 package rows | 20250207_cd1e9f84-607a-46d3-b01e-2736018d67b6.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0006-5007-01 | 00006500701 | 30 TABLET, FILM COATED in 1 BOTTLE (0006-5007-01) | 2018-07-20 | 0000-00-00 | No | No | Current |