NDC 76519-1130

ISENTRESS

Raltegravir

ISENTRESS is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by H.j. Harkins Company Inc.. The primary component is Raltegravir Potassium.

• Product ID: 76519-1130_5554d179-32de-531e-e054-00144ff8d46c
• NDC: 76519-1130
• Product Type: Human Prescription Drug
• Proprietary Name: ISENTRESS
• Generic Name: Raltegravir
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2017-07-31
• Marketing Category: NDA / NDA
• Application Number: NDA022145
• Labeler Name: H.J. Harkins Company 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: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 76519-1130-6

6 TABLET, FILM COATED in 1 VIAL (76519-1130-6)

• Marketing Start Date: 2017-07-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 76519-1130-6 [76519113006]

ISENTRESS TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA022145
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-07-31
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
RALTEGRAVIR POTASSIUM	400 mg/1

OpenFDA Data

• SPL SET ID: 5554d179-32dd-531e-e054-00144ff8d46c
• Manufacturer:
  • H.J. Harkins Company Inc.
• UNII:
  • 43Y000U234
• RxNorm Concept Unique ID - RxCUI:
  • 744846
  • 744842

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