Home NDC 69680-115 Aminocaproic Acid
Product NDC 69680-115
11-digit product format 696800115
Labeler code 69680
Product ID 69680-115_236ce9f5-3f2f-438f-a82d-04fc57314bf7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Aminocaproic Acid
Dosage form TABLET
Route ORAL
Labeler Vitruvias Therapeutics
Application ANDA209060
Marketing category ANDA
Marketing start 2018-12-03
Substance AMINOCAPROIC ACID
Active strength 500 mg/1
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A209060-001 AMINOCAPROIC ACID AMINOCAPROIC ACID 500MG TABLET / ORAL AB 2018-11-27 A209060-002 AMINOCAPROIC ACID AMINOCAPROIC ACID 1GM TABLET / ORAL AB RS 2018-11-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 3 · 82 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 A209060-001 AMINOCAPROIC ACID 500MG TABLET / ORAL AB 2018-11-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209060-002 AMINOCAPROIC ACID 1GM TABLET / ORAL AB RS 2018-11-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209060-001 AMINOCAPROIC ACID 500MG TABLET / ORAL AB 2018-11-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209060-002 AMINOCAPROIC ACID 1GM TABLET / ORAL AB RS 2018-11-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209060-001 AMINOCAPROIC ACID 500MG TABLET / ORAL AB 2018-11-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209060-002 AMINOCAPROIC ACID 1GM TABLET / ORAL AB RS 2018-11-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209060-001 AMINOCAPROIC ACID 500MG TABLET / ORAL AB 2018-11-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209060-002 AMINOCAPROIC ACID 1GM TABLET / ORAL AB RS 2018-11-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209060-001 AMINOCAPROIC ACID 500MG TABLET / ORAL AB 2018-11-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209060-002 AMINOCAPROIC ACID 1GM TABLET / ORAL AB RS 2018-11-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209060-001 AMINOCAPROIC ACID 500MG TABLET / ORAL AB 2018-11-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209060-002 AMINOCAPROIC ACID 1GM TABLET / ORAL AB RS 2018-11-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209060-001 AMINOCAPROIC ACID 500MG TABLET / ORAL AB 2018-11-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209060-002 AMINOCAPROIC ACID 1GM TABLET / ORAL AB RS 2018-11-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209060-001 AMINOCAPROIC ACID 500MG TABLET / ORAL AB 2018-11-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209060-002 AMINOCAPROIC ACID 1GM TABLET / ORAL AB RS 2018-11-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209060-001 AMINOCAPROIC ACID 500MG TABLET / ORAL AB 2018-11-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209060-002 AMINOCAPROIC ACID 1GM TABLET / ORAL AB RS 2018-11-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209060-001 AMINOCAPROIC ACID 500MG TABLET / ORAL AB 2018-11-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A209060-002 AMINOCAPROIC ACID 1GM TABLET / ORAL AB RS 2018-11-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209060-001 AMINOCAPROIC ACID 500MG TABLET / ORAL AB 2018-11-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209060-002 AMINOCAPROIC ACID 1GM TABLET / ORAL AB RS 2018-11-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209060-001 AMINOCAPROIC ACID 500MG TABLET / ORAL AB 2018-11-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209060-002 AMINOCAPROIC ACID 1GM TABLET / ORAL AB RS 2018-11-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209060-001 AMINOCAPROIC ACID 500MG TABLET / ORAL AB 2018-11-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209060-002 AMINOCAPROIC ACID 1GM TABLET / ORAL AB RS 2018-11-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209060-001 AMINOCAPROIC ACID 500MG TABLET / ORAL AB 2018-11-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A209060-002 AMINOCAPROIC ACID 1GM TABLET / ORAL AB RS 2018-11-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209060-001 AMINOCAPROIC ACID 500MG TABLET / ORAL AB 2018-11-27 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209060-002 AMINOCAPROIC ACID 1GM TABLET / ORAL AB RS 2018-11-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209060-001 AMINOCAPROIC ACID 500MG TABLET / ORAL AB 2018-11-27 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A209060-002 AMINOCAPROIC ACID 1GM TABLET / ORAL AB RS 2018-11-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209060-001 AMINOCAPROIC ACID 500MG TABLET / ORAL AB 2018-11-27 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A209060-002 AMINOCAPROIC ACID 1GM TABLET / ORAL AB RS 2018-11-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A209060-001 AMINOCAPROIC ACID 500MG TABLET / ORAL AB 2018-11-27 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A209060-002 AMINOCAPROIC ACID 1GM TABLET / ORAL AB RS 2018-11-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A209060-001 AMINOCAPROIC ACID 500MG TABLET / ORAL AB 2018-11-27 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A209060-002 AMINOCAPROIC ACID 1GM TABLET / ORAL AB RS 2018-11-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209060-001 AMINOCAPROIC ACID 500MG TABLET / ORAL AB 2018-11-27 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A209060-002 AMINOCAPROIC ACID 1GM TABLET / ORAL AB RS 2018-11-27 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 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 500 mg/1
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197351 Internal RxNorm lookup 476271 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 69680-115-00 Aminocaproic Acid 100 in 1 BOTTLE TABLET 100 3 69680-115-30 Aminocaproic Acid 30 in 1 BOTTLE TABLET 30 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69680-115 AMINOCAPROIC ACID TABLET [VITRUVIAS THERAPEUTICS] 3 Current NDC, Legacy NDC, 2 package rows 20210317_555a0910-dbeb-4643-8b3a-c9fe9b803b3c.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 · 2 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 69680-115-00 69680011500 100 TABLET in 1 BOTTLE (69680-115-00) 100 tablet 2018-12-03 0000-00-00 No No Current 69680-115-30 69680011530 30 TABLET in 1 BOTTLE (69680-115-30) 30 tablet 2018-12-03 0000-00-00 No No Current