NDC 0085-1136

Integrilin

Eptifibatide

Integrilin is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Merck Sharp & Dohme Corp.. The primary component is Eptifibatide.

• Product ID: 0085-1136_0b07e9e2-08a4-4b8f-a3d5-81dfe25f2031
• NDC: 0085-1136
• Product Type: Human Prescription Drug
• Proprietary Name: Integrilin
• Generic Name: Eptifibatide
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2014-08-18
• Marketing Category: NDA / NDA
• Application Number: NDA020718
• Labeler Name: Merck Sharp & Dohme Corp.
• Substance Name: EPTIFIBATIDE
• Active Ingredient Strength: 1 mg/mL
• Pharm Classes: Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0085-1136-01

1 VIAL, SINGLE-USE in 1 CARTON (0085-1136-01) > 100 mL in 1 VIAL, SINGLE-USE

• Marketing Start Date: 1998-05-18
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0085-1136-01 [00085113601]

Integrilin INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA020718
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1998-05-18

NDC 0085-1136-02 [00085113602]

Integrilin INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA020718
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2014-08-18

NDC 0085-1136-03 [00085113603]

Integrilin INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA020718
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2015-01-23

Drug Details

Active Ingredients

Ingredient	Strength
EPTIFIBATIDE	.75 mg/mL

OpenFDA Data

• SPL SET ID: bd14390c-f3a1-4f19-a9d0-f137abfcddc0
• Manufacturer:
  • Merck Sharp & Dohme Corp.
• UNII:
  • NA8320J834
• RxNorm Concept Unique ID - RxCUI:
  • 261097
  • 1736478
  • 1736477
  • 1736472
  • 1736470
  • 200349

Pharmacological Class

• Decreased Platelet Aggregation [PE]
• Platelet Aggregation Inhibitor [EPC]

NDC Crossover Matching brand name "Integrilin" or generic name "Eptifibatide"

NDC	Brand Name	Generic Name
0085-1136	Integrilin	Eptifibatide
0085-1177	Integrilin	Eptifibatide
0338-9558	Eptifibatide	Eptifibatide
0338-9559	Eptifibatide	Eptifibatide
0703-1165	Eptifibatide	Eptifibatide
14335-070	Eptifibatide	eptifibatide
14335-071	Eptifibatide	eptifibatide
16729-259	EPTIFIBATIDE	Eptifibatide
16729-260	EPTIFIBATIDE	Eptifibatide
17478-902	Eptifibatide	Eptifibatide
17478-903	Eptifibatide	Eptifibatide
25021-408	eptifibatide	eptifibatide
25021-409	eptifibatide	eptifibatide
52958-040	Eptifibatide	Eptifibatide
52958-402	Eptifibatide	Eptifibatide