Home NDC 54288-151 Aminocaproic acid
Product NDC 54288-151
11-digit product format 542880151
Labeler code 54288
Product ID 54288-151_f8d071d1-03b0-4b2b-b766-9304fd9834fb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Aminocaproic acid
Dosage form SOLUTION
Route ORAL
Labeler BPI LABS LLC
Application ANDA213825
Marketing category ANDA
Marketing start 2022-05-16
Substance AMINOCAPROIC ACID
Active strength .25 g/mL
Pharmacologic classes Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]
NDC exclude flag No
Listing certified through 2027-12-31
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 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 54288-151-01 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 54288-151-01 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 54288-151-01 0efc9e666f02…f202fb6c5f17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A213825-001 AMINOCAPROIC ACID AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2021-04-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A213825-001 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 2026-02-19 14:30 UTC 2026-02 A213825-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2021-04-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213825-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2021-04-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213825-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2021-04-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213825-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2021-04-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213825-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2021-04-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213825-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2021-04-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213825-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2021-04-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213825-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2021-04-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213825-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2021-04-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213825-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2021-04-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213825-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2021-04-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213825-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2021-04-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213825-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2021-04-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213825-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2021-04-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213825-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2021-04-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A213825-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2021-04-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A213825-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2021-04-08 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A213825-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2021-04-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A213825-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2021-04-08 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213825-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2021-04-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A213825-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2021-04-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A213825-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2021-04-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A213825-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2021-04-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213825-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2021-04-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A213825-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2021-04-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A213825-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2021-04-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A213825-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2021-04-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A213825-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2021-04-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A213825-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2021-04-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A213825-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2021-04-08 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A213825-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2021-04-08 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A213825-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2021-04-08 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213825-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2021-04-08 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Aminocaproic acid
Listing expiration 2027-12-31 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 54288-151-01 Aminocaproic acid 236.5 mL in 1 BOTTLE, PLASTIC SOLUTION 236.5 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54288-151 AMINOCAPROIC ACID SOLUTION [BPI LABS LLC] 5 Current NDC, Legacy NDC, 1 package rows 20250213_cfa601c4-b649-417e-a301-b246f080f1eb.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 Marketing end Sample Exclude flag Status 54288-151-01 54288015101 236.5 mL in 1 BOTTLE, PLASTIC (54288-151-01) 236.5 ml 2022-05-16 0000-00-00 No No Current