Home NDC 0013-1114 Cyklokapron
Product NDC 0013-1114
11-digit product format 000131114
Labeler code 0013
Product ID 0013-1114_9776ef50-2235-40ba-9245-de06f7b4d019
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tranexamic acid
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Pfizer Laboratories Div Pfizer Inc
Application NDA019281
Marketing category NDA
Marketing start 1986-12-30
Substance TRANEXAMIC ACID
Active strength 100 mg/mL
Pharmacologic classes Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 N019281-001 CYKLOKAPRON TRANEXAMIC ACID 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N019281-001 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.
Product history page 1 of 2 · 42 observed 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 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N019281-001 CYKLOKAPRON 100MG/ML INJECTABLE / INJECTION AP RLD, RS 1986-12-30 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Cyklokapron
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TRANEXAMIC ACID 100 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 208104 Internal RxNorm lookup 238720 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 0013-1114-01 Cyklokapron 10 mL in 1 AMPULE INJECTION, SOLUTION 10 34 0013-1114-10 Cyklokapron 10 in 1 BOX INJECTION, SOLUTION 10 34 0013-1114-10 Cyklokapron 1 in 1 CARTON INJECTION, SOLUTION 1 34 0013-1114-15 Cyklokapron 1 in 1 CARTON INJECTION, SOLUTION 1 34 0013-1114-20 Cyklokapron 10 mL in 1 VIAL INJECTION, SOLUTION 10 34 0013-1114-21 Cyklokapron 10 in 1 BOX INJECTION, SOLUTION 10 34
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0013-1114 CYKLOKAPRON (TRANEXAMIC ACID) INJECTION, SOLUTION [PFIZER LABORATORIES DIV PFIZER INC] 33 Current NDC, Legacy NDC, 6 package rows 20250216_6e89a7d9-4da4-42aa-b7f8-c602c24eefe5.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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Cyklokapron TRANEXAMIC ACID Pfizer Laboratories Div Pfizer Inc 6e89a7d9-4da4-42aa-b7f8-c602c24eefe5 2025-09-03 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 019281 application number: NDA019281 ndc (product): 0013-1114
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0013-1114-01 00013111401 10 mL in 1 AMPULE 10 ml Historical 0013-1114-10 00013111410 10 in 1 BOX Historical 0013-1114-15 00013111415 1 AMPULE in 1 CARTON (0013-1114-15) / 10 mL in 1 AMPULE (0013-1114-01) 1 ampule 2018-11-21 0000-00-00 No No Current 0013-1114-20 00013111420 10 mL in 1 VIAL 10 ml Historical 0013-1114-21 00013111421 10 VIAL in 1 BOX (0013-1114-21) / 10 mL in 1 VIAL (0013-1114-20) 10 vial 1986-12-30 0000-00-00 No No Current