PIFELTRO
- Product NDC
- 0006-3069
- 11-digit product format
- 000063069
- Labeler code
- 0006
- Product ID
- 0006-3069_20dc2455-4d48-4183-b1ad-29a2686dcd2a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- doravirine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Merck Sharp & Dohme LLC
- Application
- NDA210806
- Marketing category
- NDA
- Marketing start
- 2018-07-20
- Substance
- DORAVIRINE
- Active strength
- 100 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- PIFELTRO
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DORAVIRINE | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 913P6LK81M |
| Rxcui | 2055760, 2055766 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0006-3069-01 | PIFELTRO | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 20 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0006-3069 | PIFELTRO (DORAVIRINE) TABLET, FILM COATED [MERCK SHARP & DOHME LLC] | 18 | Current NDC, Legacy NDC, 1 package rows | 20241122_76ce1f00-28c0-4314-bd2c-d473fe3d0970.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 |
|---|
| 0006-3069-01 | 00006306901 | 30 TABLET, FILM COATED in 1 BOTTLE (0006-3069-01) | 2018-07-20 | 0000-00-00 | No | No | Current |