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| NDC | 70771-1085-6 |
| Set ID | 572b90ba-4a04-466c-bf6b-49a0d7c6b5d4 |
| Category | HUMAN PRESCRIPTION DRUG LABEL |
| Packager | Cadila Healthcare Limited |
| Generic Name | |
| Product Class | Antifibrinolytic Agent |
| Product Number | |
| Application Number | ANDA205228 |
- SPL UNCLASSIFIED SECTION
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 70771-1085-1
Tranexamic Acid Injection
1000 mg/10 mL
(100 mg/mL)
Solution for Intravenous Injection
Discard any remaining portion after single use.
10 mL Single-Dose Vial
Rx only
zydus pharmaceuticals
NDC 70771-1085-6
Tranexamic Acid Injection
1000 mg/10 mL
(100 mg/mL)
Solution for Intravenous Injection
Discard any remaining portion after single use.
10 X 10 mL Single-Dose Vials
Rx only
zydus pharmaceuticals
-
INGREDIENTS AND APPEARANCE
TRANEXAMIC ACID
tranexamic acid injectionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1085 Route of Administration INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRANEXAMIC ACID (UNII: 6T84R30KC1) (TRANEXAMIC ACID - UNII:6T84R30KC1) TRANEXAMIC ACID 100 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1085-6 10 in 1 CARTON 10/04/2017 1 10 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA205228 10/04/2017 Labeler - Cadila Healthcare Limited (918596198) Registrant - Cadila Healthcare Limited (918596198) Establishment Name Address ID/FEI Business Operations Cadila Healthcare Limited 918596198 ANALYSIS(70771-1085) , MANUFACTURE(70771-1085)