Home NDC 0517-9191 Aminocaproic Acid
Product NDC 0517-9191
11-digit product format 005179191
Labeler code 0517
Product ID 0517-9191_eea945f2-15ce-4ac9-b786-90f68f6e634c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Aminocaproic Acid
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler American Regent, Inc.
Application ANDA071192
Marketing category ANDA
Marketing start 2019-02-01
Substance AMINOCAPROIC ACID
Active strength 250 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 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 A071192-001 AMINOCAPROIC ACID AMINOCAPROIC ACID 250MG/ML INJECTABLE / INJECTION AP 1987-12-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A071192-001 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 · 41 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 2026-02-19 14:30 UTC 2026-02 A071192-001 AMINOCAPROIC ACID 250MG/ML INJECTABLE / INJECTION AP 1987-12-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071192-001 AMINOCAPROIC ACID 250MG/ML INJECTABLE / INJECTION AP 1987-12-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A071192-001 AMINOCAPROIC ACID 250MG/ML INJECTABLE / INJECTION AP 1987-12-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071192-001 AMINOCAPROIC ACID 250MG/ML INJECTABLE / INJECTION AP 1987-12-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071192-001 AMINOCAPROIC ACID 250MG/ML INJECTABLE / INJECTION AP 1987-12-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071192-001 AMINOCAPROIC ACID 250MG/ML INJECTABLE / INJECTION AP 1987-12-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071192-001 AMINOCAPROIC ACID 250MG/ML INJECTABLE / INJECTION AP 1987-12-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071192-001 AMINOCAPROIC ACID 250MG/ML INJECTABLE / INJECTION AP 1987-12-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071192-001 AMINOCAPROIC ACID 250MG/ML INJECTABLE / INJECTION AP 1987-12-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A071192-001 AMINOCAPROIC ACID 250MG/ML INJECTABLE / INJECTION AP 1987-12-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071192-001 AMINOCAPROIC ACID 250MG/ML INJECTABLE / INJECTION AP 1987-12-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A071192-001 AMINOCAPROIC ACID 250MG/ML INJECTABLE / INJECTION AP 1987-12-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A071192-001 AMINOCAPROIC ACID 250MG/ML INJECTABLE / INJECTION AP 1987-12-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A071192-001 AMINOCAPROIC ACID 250MG/ML INJECTABLE / INJECTION AP 1987-12-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A071192-001 AMINOCAPROIC ACID 250MG/ML INJECTABLE / INJECTION AP 1987-12-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A071192-001 AMINOCAPROIC ACID 250MG/ML INJECTABLE / INJECTION AP 1987-12-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A071192-001 AMINOCAPROIC ACID 250MG/ML INJECTABLE / INJECTION AP 1987-12-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A071192-001 AMINOCAPROIC ACID 250MG/ML INJECTABLE / INJECTION AP 1987-12-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A071192-001 AMINOCAPROIC ACID 250MG/ML INJECTABLE / INJECTION AP 1987-12-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A071192-001 AMINOCAPROIC ACID 250MG/ML INJECTABLE / INJECTION AP 1987-12-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A071192-001 AMINOCAPROIC ACID 250MG/ML INJECTABLE / INJECTION AP 1987-12-01 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A071192-001 AMINOCAPROIC ACID 250MG/ML INJECTABLE / INJECTION AP 1987-12-01 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A071192-001 AMINOCAPROIC ACID 250MG/ML INJECTABLE / INJECTION AP 1987-12-01 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A071192-001 AMINOCAPROIC ACID 250MG/ML INJECTABLE / INJECTION AP 1987-12-01 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A071192-001 AMINOCAPROIC ACID 250MG/ML INJECTABLE / INJECTION AP 1987-12-01 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A071192-001 AMINOCAPROIC ACID 250MG/ML INJECTABLE / INJECTION AP 1987-12-01 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A071192-001 AMINOCAPROIC ACID 250MG/ML INJECTABLE / INJECTION AP 1987-12-01 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A071192-001 AMINOCAPROIC ACID 250MG/ML INJECTABLE / INJECTION AP 1987-12-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A071192-001 AMINOCAPROIC ACID 250MG/ML INJECTABLE / INJECTION AP 1987-12-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A071192-001 AMINOCAPROIC ACID 250MG/ML INJECTABLE / INJECTION AP 1987-12-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A071192-001 AMINOCAPROIC ACID 250MG/ML INJECTABLE / INJECTION AP 1987-12-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A071192-001 AMINOCAPROIC ACID 250MG/ML INJECTABLE / INJECTION AP 1987-12-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A071192-001 AMINOCAPROIC ACID 250MG/ML INJECTABLE / INJECTION AP 1987-12-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A071192-001 AMINOCAPROIC ACID 250MG/ML INJECTABLE / INJECTION AP 1987-12-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A071192-001 AMINOCAPROIC ACID 250MG/ML INJECTABLE / INJECTION AP 1987-12-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A071192-001 AMINOCAPROIC ACID 250MG/ML INJECTABLE / INJECTION AP 1987-12-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A071192-001 AMINOCAPROIC ACID 250MG/ML INJECTABLE / INJECTION AP 1987-12-01 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A071192-001 AMINOCAPROIC ACID 250MG/ML INJECTABLE / INJECTION AP 1987-12-01 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A071192-001 AMINOCAPROIC ACID 250MG/ML INJECTABLE / INJECTION AP 1987-12-01 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A071192-001 AMINOCAPROIC ACID 250MG/ML INJECTABLE / INJECTION AP 1987-12-01 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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 250 mg/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 238719 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 0517-9191-01 Aminocaproic Acid 20 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 20 4 0517-9191-25 Aminocaproic Acid 25 in 1 TRAY INJECTION, SOLUTION 25 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0517-9191 AMINOCAPROIC ACID INJECTION, SOLUTION [AMERICAN REGENT, INC.] 4 Current NDC, Legacy NDC, 2 package rows 20220107_08bfb83e-3ac5-4e66-84a3-fcd4deaf73ae.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Aminocaproic Acid AMINOCAPROIC ACID Medical Purchasing Solutions, LLC 15eadaf4-5801-8044-e063-6394a90a72cf 2024-04-12 Warnings, Adverse reactions Exact identifier application applno (ANDA): 071192 application number: ANDA071192 Aminocaproic Acid AMINOCAPROIC ACID Civica, Inc. 36283eb3-f98e-446f-ade7-ce7864cd5779 2020-09-21 Warnings, Adverse reactions Exact identifier application applno (ANDA): 071192 application number: ANDA071192 Aminocaproic Acid AMINOCAPROIC ACID American Regent, Inc. 08bfb83e-3ac5-4e66-84a3-fcd4deaf73ae 2020-07-16 Warnings, Adverse reactions Exact identifier application applno (ANDA): 071192 application number: ANDA071192 ndc (product): 0517-9191 Aminocaproic Acid AMINOCAPROIC ACID American Regent, Inc. f4f65667-c349-420b-b7b7-f20f3a4e4d4e 2019-12-06 Warnings, Adverse reactions Exact identifier application applno (ANDA): 071192 application number: ANDA071192
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 0517-9191-01 00517919101 20 mL in 1 VIAL, MULTI-DOSE 20 ml Historical 0517-9191-25 00517919125 25 VIAL, MULTI-DOSE in 1 TRAY (0517-9191-25) / 20 mL in 1 VIAL, MULTI-DOSE (0517-9191-01) 2019-02-01 0000-00-00 No No Current