ISENTRESS
- Product NDC
- 53808-0650
- 11-digit product format
- 538080650
- Labeler code
- 53808
- Product ID
- 53808-0650_7e55b122-534a-4fcc-9b47-f7263d25b363
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- raltegravir
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- State of Florida DOH Central Pharmacy
- Application
- NDA022145
- Marketing category
- NDA
- Marketing start
- 2009-07-01
- 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
- E
- Listing certified through
- 2018-12-31
- 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 |
|---|
| 53808-0650-1 | ISENTRESS | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | | 3 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| RALTEGRAVIR POTASSIUM | ACTIVE INGREDIENT | 43Y000U234 | ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 3 | |
| RALTEGRAVIR | ACTIVE MOIETY | 22VKV8053U | ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 3 | |
| ANHYDROUS DIBASIC CALCIUM PHOSPHATE | INACTIVE INGREDIENT | L11K75P92J | ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 3 | |
| BUTYLATED HYDROXYTOLUENE | INACTIVE INGREDIENT | 1P9D0Z171K | ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 3 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 3 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 3 | |
| HYPROMELLOSE | INACTIVE INGREDIENT | 3NXW29V3WO | ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 3 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 3 | |
| POLOXAMER 407 | INACTIVE INGREDIENT | TUF2IVW3M2 | ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 3 | |
| POLYETHYLENE GLYCOL 3350 | INACTIVE INGREDIENT | G2M7P15E5P | ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 3 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 3 | |
| SODIUM STEARYL FUMARATE | INACTIVE INGREDIENT | 7CV7WJK4UI | ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 3 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53808-0650 | ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 3 | Legacy NDC, 1 package rows | 20100813_cbd3e1af-81f3-44f6-8e45-652deab7a508.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 53808-0650-1 | 53808065001 | 30 in 1 BLISTER PACK | Historical |