Dovato
- Product NDC
- 49702-246
- 11-digit product format
- 497020246
- Labeler code
- 49702
- Product ID
- 49702-246_9b88da25-ebce-49ae-8c8a-dcee6f465957
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- dolutegravir sodium and lamivudine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- ViiV Healthcare Company
- Application
- NDA211994
- Marketing category
- NDA
- Marketing start
- 2019-04-08
- Substance
- DOLUTEGRAVIR SODIUM; LAMIVUDINE
- Active strength
- 50; 300 mg/1; mg/1
- Pharmacologic classes
- HIV Integrase Inhibitors [MoA], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Organic Cation Transporter 2 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
- Dovato
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DOLUTEGRAVIR SODIUM | 50 mg/1 |
| LAMIVUDINE | 300 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1Q1V9V5WYQ, 2T8Q726O95 |
| Rxcui | 2122519, 2122526 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 49702-246-13 | Dovato | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 19 |
| 49702-246-33 | Dovato | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 19 |
| 49702-246-33 | Dovato | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | | 19 |
| 49702-246-62 | Dovato | 14 in 1 BLISTER PACK | TABLET, FILM COATED | 14 | | 19 |
| 49702-246-62 | Dovato | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 19 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 49702-246 | DOVATO (DOLUTEGRAVIR SODIUM AND LAMIVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY] | 16 | Current NDC, Legacy NDC, 5 package rows | 20240921_68e45422-43ed-4cfb-9356-fae88d14a53a.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 |
|---|
| 49702-246-13 | 49702024613 | 30 TABLET, FILM COATED in 1 BOTTLE (49702-246-13) | | 2019-04-08 | 0000-00-00 | No | No | Current |
| 49702-246-33 | 49702024633 | 1 BLISTER PACK in 1 CARTON (49702-246-33) / 30 TABLET, FILM COATED in 1 BLISTER PACK | 1 blister pack | 2024-01-01 | | No | No | Current |
| 49702-246-61 | 49702024661 | 14 TABLET, FILM COATED in 1 BOTTLE (49702-246-61) | | 2019-08-06 | 0000-00-00 | No | No | Current |
| 49702-246-62 | 49702024662 | 1 BLISTER PACK in 1 CARTON (49702-246-62) / 14 TABLET, FILM COATED in 1 BLISTER PACK | 1 blister pack | 2024-01-01 | | No | No | Current |