TRANEXAMIC ACID (Page 4 of 4)

PRINCIPAL DISPLAY PANEL — 51662-1532-2 POUCH AND VIAL LABELING

POUCH LABELING
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Vial Labeling
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PRINCIPAL DISPLAY PANEL — 51662-1532-3 SERIALIZED LABELING & CASE LABELING

SEERIALIZED LABELING
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Case Labeling
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PRINCIPAL DISPLAY PANEL — 51662-1532-1 SERIALIZED VIAL LABELING

SERIALIZED VIAL LABELING
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Vial
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TRANEXAMIC ACID tranexamic acid injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51662-1532(NDC:55150-188)
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:51662-1532-3 10 POUCH in 1 CASE contains a POUCH (51662-1532-2)
1 NDC:51662-1532-2 1 VIAL, SINGLE-DOSE in 1 POUCH This package is contained within the CASE (51662-1532-3) and contains a VIAL, SINGLE-DOSE
1 10 mL in 1 VIAL, SINGLE-DOSE This package is contained within a POUCH (51662-1532-2) and a CASE (51662-1532-3)
2 NDC:51662-1532-1 10 mL in 1 VIAL, SINGLE-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205035 06/20/2021
Labeler — HF Acquisition Co LLC, DBA HealthFirst (045657305)
Registrant — HF Acquisition Co LLC, DBA HealthFirst (045657305)
Establishment
Name Address ID/FEI Operations
HF Acquisition Co LLC, DBA HealthFirst 045657305 relabel (51662-1532)

Revised: 06/2021 HF Acquisition Co LLC, DBA HealthFirst

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