Mavyret
- Product NDC
- 0074-2625
- 11-digit product format
- 000742625
- Labeler code
- 0074
- Product ID
- 0074-2625_2c392930-500d-4e9b-93ac-317c4d48251c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glecaprevir and Pibrentasvir
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- AbbVie Inc.
- Application
- NDA209394
- Marketing category
- NDA
- Marketing start
- 2017-08-03
- Substance
- GLECAPREVIR; PIBRENTASVIR
- Active strength
- 100; 40 mg/1; mg/1
- Pharmacologic classes
- Breast Cancer Resistance Protein Inhibitors [MoA], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], HCV NS3/4A Protease Inhibitors [MoA], Hepatitis C Virus NS3/4A Protease Inhibitor [EPC], Hepatitis C Virus NS5A Inhibitor [EPC], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], UGT1A1 Inhibitors [MoA], UGT1A1 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
- Mavyret
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GLECAPREVIR | 100 mg/1 |
| PIBRENTASVIR | 40 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | K6BUU8J72P, 2WU922TK3L |
| Rxcui | 1940703, 1940709, 2557906, 2557910 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0074-2625-01 | Mavyret | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 200 |
| 0074-2625-01 | Mavyret | 3 in 1 DOSE PACK | TABLET, FILM COATED | 3 | | 200 |
| 0074-2625-04 | Mavyret | 4 in 1 CARTON | TABLET, FILM COATED | 4 | | 200 |
| 0074-2625-04 | Mavyret | 7 in 1 CARTON | TABLET, FILM COATED | 7 | | 200 |
| 0074-2625-28 | Mavyret | 7 in 1 CARTON | TABLET, FILM COATED | 7 | | 200 |
| 0074-2625-28 | Mavyret | 4 in 1 CARTON | TABLET, FILM COATED | 4 | | 200 |
| 0074-2625-56 | Mavyret | 4 in 1 CARTON | TABLET, FILM COATED | 4 | | 200 |
| 0074-2625-56 | Mavyret | 2 in 1 CARTON | TABLET, FILM COATED | 2 | | 200 |
| 0074-2625-80 | Mavyret | 84 in 1 BOTTLE | TABLET, FILM COATED | 84 | | 200 |
| 0074-2625-84 | Mavyret | 84 in 1 BOTTLE | TABLET, FILM COATED | 84 | | 200 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0074-2625 | MAVYRET (GLECAPREVIR AND PIBRENTASVIR) TABLET, FILM COATED MAVYRET (GLECAPREVIR AND PIBRENTASVIR) PELLET [ABBVIE INC.] | 197 | Current NDC, Legacy NDC, 10 package rows | 20250425_7bf99777-0401-9095-8645-16c6e907fcc0.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 |
|---|
| 0074-2625-01 | 00074262501 | 1 DOSE PACK in 1 CARTON (0074-2625-01) > 3 TABLET, FILM COATED in 1 DOSE PACK | 1 dose pack | 2017-08-03 | 0000-00-00 | No | No | Current |
| 0074-2625-04 | 00074262504 | 4 CARTON in 1 CARTON (0074-2625-04) / 7 BLISTER PACK in 1 CARTON / 3 TABLET, FILM COATED in 1 BLISTER PACK | 4 carton | 2025-04-15 | | No | No | Current |
| 0074-2625-28 | 00074262528 | 4 CARTON in 1 CARTON (0074-2625-28) / 7 DOSE PACK in 1 CARTON / 3 TABLET, FILM COATED in 1 DOSE PACK | 4 carton | 2017-08-03 | 0000-00-00 | No | No | Current |
| 0074-2625-56 | 00074262556 | 2 CARTON in 1 CARTON (0074-2625-56) / 4 CARTON in 1 CARTON / 7 DOSE PACK in 1 CARTON / 3 TABLET, FILM COATED in 1 DOSE PACK | 2 carton | 2017-08-03 | 0000-00-00 | No | No | Current |
| 0074-2625-80 | 00074262580 | 84 TABLET, FILM COATED in 1 BOTTLE (0074-2625-80) | | 2019-06-27 | 0000-00-00 | No | No | Current |
| 0074-2625-84 | 00074262584 | 84 TABLET, FILM COATED in 1 BOTTLE (0074-2625-84) | | 2021-06-22 | 0000-00-00 | No | No | Current |