Tivicay
- Product NDC
- 49702-227
- 11-digit product format
- 497020227
- Labeler code
- 49702
- Product ID
- 49702-227_a9175b83-2200-4bd2-9ee3-52095b5d2657
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- dolutegravir sodium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- ViiV Healthcare Company
- Application
- NDA204790
- Marketing category
- NDA
- Marketing start
- 2016-06-09
- Marketing end
- 2027-05-31
- Substance
- DOLUTEGRAVIR SODIUM
- Active strength
- 25 mg/1
- Pharmacologic classes
- HIV Integrase Inhibitors [MoA], Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC], Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Tivicay
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DOLUTEGRAVIR SODIUM | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1Q1V9V5WYQ |
| Rxcui | 1433873, 1433879, 1796077, 1796079, 1796081, 1796083, 2374562, 2374566 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 49702-227-13 | Tivicay | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 31 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DOLUTEGRAVIR SODIUM | ACTIVE INGREDIENT | 1Q1V9V5WYQ | TIVICAY (DOLUTEGRAVIR SODIUM) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY] | 7 | |
| DOLUTEGRAVIR | ACTIVE MOIETY | DKO1W9H7M1 | TIVICAY (DOLUTEGRAVIR SODIUM) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY] | 7 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | TIVICAY (DOLUTEGRAVIR SODIUM) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY] | 7 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | TIVICAY (DOLUTEGRAVIR SODIUM) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY] | 7 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | TIVICAY (DOLUTEGRAVIR SODIUM) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY] | 7 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | TIVICAY (DOLUTEGRAVIR SODIUM) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY] | 7 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | TIVICAY (DOLUTEGRAVIR SODIUM) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY] | 7 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | TIVICAY (DOLUTEGRAVIR SODIUM) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY] | 7 | |
| SODIUM STARCH GLYCOLATE TYPE A CORN | INACTIVE INGREDIENT | AG9B65PV6B | TIVICAY (DOLUTEGRAVIR SODIUM) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY] | 7 | |
| SODIUM STEARYL FUMARATE | INACTIVE INGREDIENT | 7CV7WJK4UI | TIVICAY (DOLUTEGRAVIR SODIUM) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY] | 7 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | TIVICAY (DOLUTEGRAVIR SODIUM) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY] | 7 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | TIVICAY (DOLUTEGRAVIR SODIUM) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY] | 7 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 49702-227 | TIVICAY PD (DOLUTEGRAVIR SODIUM) TABLET, FOR SUSPENSION TIVICAY (DOLUTEGRAVIR SODIUM) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY] | 29 | Current NDC, Legacy NDC, 1 package rows | 20240907_63df5af3-b8ac-4e76-9830-2dbb340af922.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 |
|---|
| 49702-227-13 | 49702022713 | 30 TABLET, FILM COATED in 1 BOTTLE (49702-227-13) | 2016-06-09 | 2027-05-31 | No | No | Current |