Home NDC 69680-114-08 Aminocaproic Acid
Product NDC 69680-114
Requested package NDC 69680-114-08
11-digit product format 696800114
Labeler code 69680
Product ID 69680-114_bd7708b6-f22e-490e-a124-47dd674d7c8b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Aminocaproic Acid
Dosage form SOLUTION
Route ORAL
Labeler Vitruvias Therapeutics
Application ANDA213213
Marketing category ANDA
Marketing start 2024-07-19
Substance AMINOCAPROIC ACID
Active strength .25 g/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 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 69680-114 69680-114-08 D Discontinued by firm excluded / ndc_excluded.zip 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 A213213-001 AMINOCAPROIC ACID AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2023-12-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A213213-001 AA
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 A213213-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2023-12-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213213-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2023-12-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213213-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2023-12-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213213-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2023-12-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213213-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2023-12-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213213-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2023-12-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213213-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2023-12-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213213-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2023-12-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213213-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2023-12-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213213-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2023-12-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213213-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2023-12-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213213-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2023-12-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213213-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2023-12-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213213-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2023-12-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213213-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2023-12-27 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213213-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2023-12-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A213213-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2023-12-27 1c564ffb4f44…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213213-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2023-12-27 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Aminocaproic Acid
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AMINOCAPROIC ACID .25 g/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination U6F3787206 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 582299 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 69680-114-08 Aminocaproic Acid 236.5 mL in 1 BOTTLE SOLUTION 236.5 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69680-114 AMINOCAPROIC ACID SOLUTION [VITRUVIAS THERAPEUTICS] 7 Current NDC, 1 package rows 20240720_d9f615a0-119c-4553-93a7-b30025b5fe14.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 69680-114-08 69680011408 236.5 mL in 1 BOTTLE (69680-114-08) 236.5 ml 2024-07-19 No No Current