Home NDC 65219-534 TRANEXAMIC ACID IN SODIUM CHLORIDE
Product NDC 65219-534
11-digit product format 652190534
Labeler code 65219
Product ID 65219-534_63b55787-c021-4399-b16f-a445eaeb8e5b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tranexamic acid
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA218242
Marketing category ANDA
Marketing start 2024-12-01
Substance TRANEXAMIC ACID
Active strength 10 mg/mL
Pharmacologic classes Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A218242-001 TRANEXAMIC ACID TRANEXAMIC ACID 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2024-08-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A218242-001 AP
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A218242-001 TRANEXAMIC ACID 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2024-08-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218242-001 TRANEXAMIC ACID 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2024-08-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218242-001 TRANEXAMIC ACID 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2024-08-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218242-001 TRANEXAMIC ACID 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2024-08-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218242-001 TRANEXAMIC ACID 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2024-08-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218242-001 TRANEXAMIC ACID 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2024-08-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218242-001 TRANEXAMIC ACID 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2024-08-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218242-001 TRANEXAMIC ACID 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2024-08-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A218242-001 TRANEXAMIC ACID 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2024-08-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218242-001 TRANEXAMIC ACID 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2024-08-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A218242-001 TRANEXAMIC ACID 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2024-08-15 d06236e962d9…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218242-001 TRANEXAMIC ACID 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2024-08-15 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base TRANEXAMIC ACID IN SODIUM CHLORIDE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TRANEXAMIC ACID 10 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6T84R30KC1 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2170286 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 65219-534-01 TRANEXAMIC ACID IN SODIUM CHLORIDE 100 mL in 1 BAG INJECTION, SOLUTION 100 3 65219-534-10 TRANEXAMIC ACID IN SODIUM CHLORIDE 24 in 1 CASE INJECTION, SOLUTION 24 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65219-534 TRANEXAMIC ACID IN SODIUM CHLORIDE (TRANEXAMIC ACID) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 3 Current NDC, 2 package rows 20241215_63f6c65f-b06b-4905-8ff8-3ac87569c7e0.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 65219-534-01 65219053401 100 mL in 1 BAG 100 ml Historical 65219-534-10 65219053410 24 BAG in 1 CASE (65219-534-10) / 100 mL in 1 BAG (65219-534-01) 24 bag 2024-12-01 No No Current