NDC 67296-1235
ISENTRESS
Isentress
ISENTRESS is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Redpharm Drug, Inc.. The primary component is Raltegravir Potassium.
| Product ID | 67296-1235_4f31df66-7dc8-1f04-e054-00144ff88e88 |
| NDC | 67296-1235 |
| Product Type | Human Prescription Drug |
| Proprietary Name | ISENTRESS |
| Generic Name | Isentress |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2007-10-12 |
| Marketing Category | NDA / NDA |
| Application Number | NDA022145 |
| Labeler Name | RedPharm Drug, Inc. |
| Substance Name | RALTEGRAVIR POTASSIUM |
| Active Ingredient Strength | 400 mg/1 |
| Pharm Classes | HIV Integrase Inhibitors [MoA],Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC] |
| NDC Exclude Flag | E |
| Listing Certified Through | 2018-12-31 |
Packaging
NDC 67296-1235-6
6 TABLET, FILM COATED in 1 BOTTLE (67296-1235-6)
| Marketing Start Date | 2007-10-12 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 67296-1235-6 [67296123506]
ISENTRESS TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA022145 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2007-10-12 |
NDC 67296-1235-8 [67296123508]
ISENTRESS TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA022145 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2007-10-12 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| RALTEGRAVIR POTASSIUM | 400 mg/1 |
OpenFDA Data
| SPL SET ID: | 4f31df66-7dc7-1f04-e054-00144ff88e88 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
Pharmacological Class
- HIV Integrase Inhibitors [MoA]
- Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC]
NDC Crossover Matching brand name "ISENTRESS" or generic name "Isentress"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0006-0227 | ISENTRESS | RALTEGRAVIR |
| 0006-0473 | ISENTRESS | RALTEGRAVIR |
| 0006-0477 | ISENTRESS | RALTEGRAVIR |
| 0006-3080 | ISENTRESS | RALTEGRAVIR |
| 0006-3603 | ISENTRESS | RALTEGRAVIR |
| 50090-1085 | ISENTRESS | RALTEGRAVIR |
| 53808-0650 | ISENTRESS | raltegravir |
| 61919-706 | ISENTRESS | ISENTRESS |
| 66336-214 | ISENTRESS | RALTEGRAVIR |
| 67296-1235 | ISENTRESS | ISENTRESS |
| 68071-2113 | ISENTRESS | RALTEGRAVIR |
| 70518-1621 | ISENTRESS | ISENTRESS |
| 76519-1130 | ISENTRESS | ISENTRESS |
Trademark Results [ISENTRESS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ISENTRESS 78866853 3357758 Live/Registered |
MERCK SHARP & DOHME CORP. 2006-04-21 |
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