NDC 53808-0650

ISENTRESS

Raltegravir

ISENTRESS is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by State Of Florida Doh Central Pharmacy. The primary component is Raltegravir Potassium.

• Product ID: 53808-0650_7e55b122-534a-4fcc-9b47-f7263d25b363
• NDC: 53808-0650
• Product Type: Human Prescription Drug
• Proprietary Name: ISENTRESS
• Generic Name: Raltegravir
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2009-07-01
• Marketing Category: NDA / NDA
• Application Number: NDA022145
• Labeler Name: State of Florida DOH Central Pharmacy
• 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 53808-0650-1

30 TABLET, FILM COATED in 1 BLISTER PACK (53808-0650-1)

• Marketing Start Date: 2009-07-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 53808-0650-1 [53808065001]

ISENTRESS TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA022145
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-07-01
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
RALTEGRAVIR POTASSIUM	400 mg/1

OpenFDA Data

• SPL SET ID: cbd3e1af-81f3-44f6-8e45-652deab7a508
• Manufacturer:
  • State of Florida DOH Central Pharmacy
• UNII:
  • 43Y000U234
• RxNorm Concept Unique ID - RxCUI:
  • 744846
  • 744842
• UPC Code:
  • 0300060227615

Pharmacological Class

• HIV Integrase Inhibitors [MoA]
• Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC]

NDC Crossover Matching brand name "ISENTRESS" or generic name "Raltegravir"

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