Home NDC 83745-294 Aminocaproic Acid
Product NDC 83745-294
11-digit product format 837450294
Labeler code 83745
Product ID 83745-294_98a1b6f4-8251-489a-94da-f98fc1d57d7e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Aminocaproic Acid
Dosage form SOLUTION
Route ORAL
Labeler Apozeal Pharmaceuticals Inc.
Application ANDA213216
Marketing category ANDA
Marketing start 2025-11-10
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 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 A213216-001 AMINOCAPROIC ACID AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2025-05-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A213216-001 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 A213216-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2025-05-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213216-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2025-05-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213216-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2025-05-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213216-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2025-05-19 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213216-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2025-05-19 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 83745-294-08 Aminocaproic Acid 236.5 mL in 1 BOTTLE SOLUTION 236.5 1
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 83745-294-08 83745029408 236.5 mL in 1 BOTTLE (83745-294-08) 236.5 ml 2025-11-10 No No Current