NDC 66336-214

ISENTRESS

Raltegravir

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

• Product ID: 66336-214_cf313cc0-44c0-4f55-a021-8fab00af41ca
• NDC: 66336-214
• Product Type: Human Prescription Drug
• Proprietary Name: ISENTRESS
• Generic Name: Raltegravir
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2007-10-12
• Marketing Category: NDA / NDA
• Application Number: NDA022145
• Labeler Name: Dispensing Solutions, 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: 2017-12-31

Packaging

NDC 66336-214-06

6 TABLET, FILM COATED in 1 BOTTLE (66336-214-06)

• Marketing Start Date: 2007-10-12
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 66336-214-06 [66336021406]

ISENTRESS TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA022145
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2007-10-12
• Inactivation Date: 2019-11-27

Drug Details

Active Ingredients

Ingredient	Strength
RALTEGRAVIR POTASSIUM	400 mg/1

OpenFDA Data

• SPL SET ID: b05735be-d278-4c31-bfb5-ebf74ce42b89
• Manufacturer:
  • Dispensing Solutions, 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