Cyklokapron (Page 4 of 4)

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 mL Ampule Carton -- NDC 0013-1114-15
(click image for full-size original)

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 x 10 mL Ampule Box Label
(click image for full-size original)

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 Label
(click image for full-size original)

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

PRINCIPAL DISPLAY PANEL -- 10 mL Vial Box
(click image for full-size original)
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

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