Tivicay
- Product NDC
- 67296-1818
- 11-digit product format
- 672961818
- Labeler code
- 67296
- Product ID
- 67296-1818_b0016570-7e04-02f6-e053-2995a90a95b4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- dolutegravir sodium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- RedPharm Drug, Inc.
- Application
- NDA204790
- Marketing category
- NDA
- Marketing start
- 2013-08-13
- Marketing end
- 0000-00-00
- Substance
- DOLUTEGRAVIR SODIUM
- Active strength
- 50 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
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67296-1818-3 | Tivicay | 3 in 1 BOTTLE | TABLET, FILM COATED | 3 | | 5 |
| 67296-1818-5 | Tivicay | 5 in 1 BOTTLE | TABLET, FILM COATED | 5 | | 5 |
| 67296-1818-7 | Tivicay | 28 in 1 BOTTLE | TABLET, FILM COATED | 28 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67296-1818 | TIVICAY (DOLUTEGRAVIR SODIUM) TABLET, FILM COATED [REDPHARM DRUG, INC.] | 5 | Legacy NDC, 3 package rows | 20240719_b00132b8-58b1-7533-e053-2995a90a0cf1.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 |
|---|
| 67296-1818-3 | 67296181803 | 3 TABLET, FILM COATED in 1 BOTTLE (67296-1818-3) | 2013-08-13 | 0000-00-00 | No | No | Current |
| 67296-1818-5 | 67296181805 | 5 in 1 BOTTLE | | | | | Historical |
| 67296-1818-7 | 67296181807 | 28 in 1 BOTTLE | | | | | Historical |