NDC 0013-1114

Cyklokapron

Tranexamic Acid

Cyklokapron is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Pfizer Laboratories Div Pfizer Inc. The primary component is Tranexamic Acid.

• Product ID: 0013-1114_33a8b137-6998-4a68-9abd-d86baecc4ea0
• NDC: 0013-1114
• Product Type: Human Prescription Drug
• Proprietary Name: Cyklokapron
• Generic Name: Tranexamic Acid
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 1986-12-30
• Marketing Category: NDA / NDA
• Application Number: NDA019281
• Labeler Name: Pfizer Laboratories Div Pfizer Inc
• Substance Name: TRANEXAMIC ACID
• Active Ingredient Strength: 100 mg/mL
• Pharm Classes: Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 0013-1114-15

1 AMPULE in 1 CARTON (0013-1114-15) > 10 mL in 1 AMPULE (0013-1114-01)

• Marketing Start Date: 2018-11-21
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0013-1114-20 [00013111420]

Cyklokapron INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA019281
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2015-03-11

NDC 0013-1114-15 [00013111415]

Cyklokapron INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA019281
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-11-21

NDC 0013-1114-01 [00013111401]

Cyklokapron INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA019281
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2013-02-26

NDC 0013-1114-21 [00013111421]

Cyklokapron INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA019281
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1986-12-30

NDC 0013-1114-10 [00013111410]

Cyklokapron INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA019281
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1986-12-30
• Marketing End Date: 2020-06-30

Drug Details

Active Ingredients

Ingredient	Strength
TRANEXAMIC ACID	100 mg/mL

OpenFDA Data

• SPL SET ID: 6e89a7d9-4da4-42aa-b7f8-c602c24eefe5
• Manufacturer:
  • Pharmacia and Upjohn Company LLC
• UNII:
  • 6T84R30KC1
• RxNorm Concept Unique ID - RxCUI:
  • 238720
  • 208104
• UPC Code:
  • 0300131114103
  • 0300131114158

Pharmacological Class

• Antifibrinolytic Agent [EPC]
• Decreased Fibrinolysis [PE]
• Antifibrinolytic Agent [EPC]
• Decreased Fibrinolysis [PE]

NDC Crossover Matching brand name "Cyklokapron" or generic name "Tranexamic Acid"

NDC	Brand Name	Generic Name
0013-1114	Cyklokapron	tranexamic acid
0517-0960	Tranexamic Acid	tranexamic acid
0591-3720	Tranexamic Acid	Tranexamic Acid
14789-500	Tranexamic acid	TRANEXAMIC ACID
17478-017	Tranexamic Acid	Tranexamic Acid
17478-018	Tranexamic Acid	Tranexamic Acid
17478-217	TRANEXAMIC ACID	Tranexamic Acid
23155-166	Tranexamic Acid	Tranexamic Acid
23155-524	Tranexamic Acid	Tranexamic Acid
39822-1000	Tranexamic Acid	Tranexamic Acid
39822-1001	Tranexamic Acid	Tranexamic Acid