ISENTRESS
- Product NDC
- 70518-1621
- 11-digit product format
- 705181621
- Labeler code
- 70518
- Product ID
- 70518-1621_d9b8c0ba-9b03-6518-e053-2995a90ada6d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- RALTEGRAVIR
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- NDA022145
- Marketing category
- NDA
- Marketing start
- 2018-10-31
- Marketing end
- 0000-00-00
- Substance
- RALTEGRAVIR POTASSIUM
- Active strength
- 400 mg/1
- Pharmacologic classes
- HIV Integrase Inhibitors [MoA], Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-1621 | ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED [REMEDYREPACK INC.] | 8 | Legacy NDC | 20250226_cf9085f0-7353-40e1-bc40-0295ace92aab.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70518-1621-0 | 70518162100 | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-1621-0) | 2018-10-31 | 0000-00-00 | No | No | Current |
| 70518-1621-1 | 70518162101 | 6 TABLET, FILM COATED in 1 BLISTER PACK (70518-1621-1) | 2019-01-17 | 0000-00-00 | No | No | Current |
| 70518-1621-2 | 70518162102 | 8 TABLET, FILM COATED in 1 BLISTER PACK (70518-1621-2) | 2019-01-17 | 0000-00-00 | No | No | Current |