Prescription Drug Information: Cyklokapron (Page 3 of 3)

PRINCIPAL DISPLAY PANEL — 10 mL Ampule Label

Pfizer Injectables

Rx only

NDC 0013-1114-01

10 mL ampule
Cyklokapron^®
tranexamic acid injection
1000 mg/10 mL
(100 mg/mL)
Solution for intravenous injection
Single-Dose ONLY
Discard any remaining portion after single use

PAA058409

PRINCIPAL DISPLAY PANEL — 10 mL Ampule Carton — NDC 0013-1114-01

NDC 0013-1114-01

Contains 1 Ampule 10 mL
Cyklokapron^®
tranexamic acid injection

1000 mg/10 mL
(100 mg/mL)

Solution for intravenous injection

Single-Dose ONLY
Discard any remaining portionafter single use

Rx only

Pfizer Injectables

PRINCIPAL DISPLAY PANEL — 10 mL Ampule Carton — NDC 0013-1114-15

NDC 0013-1114-15

Contains 1 Ampule 10 mL
Cyklokapron^®
tranexamic acid injection

1000 mg/10 mL
(100 mg/mL)

Solution for intravenous injection

Single-Dose ONLY
Discard any remaining portionafter single use

Rx only

Pfizer Injectables

PRINCIPAL DISPLAY PANEL — 10 x 10 mL Ampule Box Label

NDC 0013-1114-10
Contains 10 of NDC 0013-1114-01
10 x 10 mL ampules
Cyklokapron^®
tranexamic acid injection
1000 mg/10 mL
(100 mg/mL)
Solution for intravenous injection
Single-Dose ONLY
Discard any remaining portion after single use

Rx only

PRINCIPAL DISPLAY PANEL — 10 mL Vial Label

NDC 0013-1114-20

10 mL Vial

Cyklokapron^®

(tranexamic acid injection)

1000 mg/10 mL

(100 mg/mL)Rx only

PRINCIPAL DISPLAY PANEL — 10 mL Vial Box

NDC 0013-1114-21
Contains 10 of NDC 0013-1114-20
Rx only

10 x 10 mL Vials

Cyklokapron^®
(tranexamic acid injection)

1000 mg/10 mL
(100 mg/mL)

Solution for intravenous injection

Single-Dose ONLY Discard any remaining portion after single use

Pfizer Injectables

TEAR HERE

CYKLOKAPRON tranexamic acid injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0013-1114 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRANEXAMIC ACID (TRANEXAMIC ACID) TRANEXAMIC ACID 100 mg in 1 mL

Inactive Ingredients Ingredient Name Strength WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0013-1114-10 10 CARTON in 1 BOX contains a CARTON 1 1 AMPULE in 1 CARTON This package is contained within the BOX (0013-1114-10) and contains a AMPULE (0013-1114-01) 1 NDC:0013-1114-01 10 mL in 1 AMPULE This package is contained within a CARTON and a BOX (0013-1114-10) 2 NDC:0013-1114-21 10 VIAL in 1 BOX contains a VIAL (0013-1114-20) 2 NDC:0013-1114-20 10 mL in 1 VIAL This package is contained within the BOX (0013-1114-21) 3 NDC:0013-1114-15 1 AMPULE in 1 CARTON contains a AMPULE (0013-1114-01) 3 NDC:0013-1114-01 10 mL in 1 AMPULE This package is contained within the CARTON (0013-1114-15)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA019281 12/30/1986

Labeler — Pfizer Laboratories Div Pfizer Inc (134489525)

Establishment
Name	Address	ID/FEI	Operations
Pfizer Manufacturing Belgium NV		370156507	ANALYSIS (0013-1114), MANUFACTURE (0013-1114), PACK (0013-1114), LABEL (0013-1114)

Establishment
Name	Address	ID/FEI	Operations
Kyowa Pharma Chemical Co., Ltd.		690852371	API MANUFACTURE (0013-1114), ANALYSIS (0013-1114)

Revised: 04/2021 Pfizer Laboratories Div Pfizer Inc