ISENTRESS
- Product NDC
- 76519-1130
- 11-digit product format
- 765191130
- Labeler code
- 76519
- Product ID
- 76519-1130_5554d179-32de-531e-e054-00144ff8d46c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- RALTEGRAVIR
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- H.J. Harkins Company Inc.
- Application
- NDA022145
- Marketing category
- NDA
- Marketing start
- 2017-07-31
- 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
- 2019-12-31
- 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 |
|---|
| 76519-1130-6 | ISENTRESS | 6 in 1 VIAL | TABLET, FILM COATED | 6 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76519-1130 | ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED [H.J. HARKINS COMPANY INC.] | 1 | Legacy NDC, 1 package rows | 20170731_5554d179-32dd-531e-e054-00144ff8d46c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 76519-1130-6 | 76519113006 | 6 in 1 VIAL | Historical |