Home NDC 0409-4346 Aminocaproic Acid
Product NDC 0409-4346
11-digit product format 004094346
Labeler code 0409
Product ID 0409-4346_eddf1507-1869-4ac6-9751-4cb12bdce2c1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name AMINOCAPROIC ACID
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Hospira, Inc.
Application ANDA070010
Marketing category ANDA
Marketing start 2010-05-12
Substance AMINOCAPROIC ACID
Active strength 250 mg/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 · 24 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 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0409-4346-10 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0409-4346-10 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0409-4346-10 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0409-4346-10 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0409-4346-10 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0409-4346-10 cdf11ea48f46…ba0047e9e063…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 0409-4346-10 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 0409-4346-10 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 0409-4346-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0409-4346-10 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0409-4346-10 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0409-4346-10 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 A070010-001 AMINOCAPROIC ACID IN PLASTIC CONTAINER AMINOCAPROIC ACID 250MG/ML INJECTABLE / INJECTION AP RS 1987-03-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A070010-001 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 · 42 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 2026-08-18 06:07:40 2026-07 A070010-001 AMINOCAPROIC ACID IN PLASTIC CONTAINER 250MG/ML INJECTABLE / INJECTION AP RS 1987-03-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A070010-001 AMINOCAPROIC ACID IN PLASTIC CONTAINER 250MG/ML INJECTABLE / INJECTION AP RS 1987-03-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070010-001 AMINOCAPROIC ACID IN PLASTIC CONTAINER 250MG/ML INJECTABLE / INJECTION AP RS 1987-03-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A070010-001 AMINOCAPROIC ACID IN PLASTIC CONTAINER 250MG/ML INJECTABLE / INJECTION AP RS 1987-03-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070010-001 AMINOCAPROIC ACID IN PLASTIC CONTAINER 250MG/ML INJECTABLE / INJECTION AP RS 1987-03-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070010-001 AMINOCAPROIC ACID IN PLASTIC CONTAINER 250MG/ML INJECTABLE / INJECTION AP RS 1987-03-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070010-001 AMINOCAPROIC ACID IN PLASTIC CONTAINER 250MG/ML INJECTABLE / INJECTION AP RS 1987-03-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A070010-001 AMINOCAPROIC ACID IN PLASTIC CONTAINER 250MG/ML INJECTABLE / INJECTION AP RS 1987-03-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A070010-001 AMINOCAPROIC ACID IN PLASTIC CONTAINER 250MG/ML INJECTABLE / INJECTION AP RS 1987-03-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A070010-001 AMINOCAPROIC ACID IN PLASTIC CONTAINER 250MG/ML INJECTABLE / INJECTION AP RS 1987-03-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A070010-001 AMINOCAPROIC ACID IN PLASTIC CONTAINER 250MG/ML INJECTABLE / INJECTION AP RS 1987-03-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A070010-001 AMINOCAPROIC ACID IN PLASTIC CONTAINER 250MG/ML INJECTABLE / INJECTION AP RS 1987-03-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A070010-001 AMINOCAPROIC ACID IN PLASTIC CONTAINER 250MG/ML INJECTABLE / INJECTION AP RS 1987-03-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A070010-001 AMINOCAPROIC ACID IN PLASTIC CONTAINER 250MG/ML INJECTABLE / INJECTION AP RS 1987-03-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A070010-001 AMINOCAPROIC ACID IN PLASTIC CONTAINER 250MG/ML INJECTABLE / INJECTION AP RS 1987-03-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A070010-001 AMINOCAPROIC ACID IN PLASTIC CONTAINER 250MG/ML INJECTABLE / INJECTION AP RS 1987-03-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A070010-001 AMINOCAPROIC ACID IN PLASTIC CONTAINER 250MG/ML INJECTABLE / INJECTION AP RS 1987-03-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A070010-001 AMINOCAPROIC ACID IN PLASTIC CONTAINER 250MG/ML INJECTABLE / INJECTION AP RS 1987-03-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A070010-001 AMINOCAPROIC ACID IN PLASTIC CONTAINER 250MG/ML INJECTABLE / INJECTION AP RS 1987-03-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A070010-001 AMINOCAPROIC ACID IN PLASTIC CONTAINER 250MG/ML INJECTABLE / INJECTION AP RS 1987-03-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A070010-001 AMINOCAPROIC ACID IN PLASTIC CONTAINER 250MG/ML INJECTABLE / INJECTION AP RS 1987-03-09 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A070010-001 AMINOCAPROIC ACID IN PLASTIC CONTAINER 250MG/ML INJECTABLE / INJECTION AP RS 1987-03-09 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A070010-001 AMINOCAPROIC ACID IN PLASTIC CONTAINER 250MG/ML INJECTABLE / INJECTION AP RS 1987-03-09 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A070010-001 AMINOCAPROIC ACID IN PLASTIC CONTAINER 250MG/ML INJECTABLE / INJECTION AP RS 1987-03-09 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A070010-001 AMINOCAPROIC ACID IN PLASTIC CONTAINER 250MG/ML INJECTABLE / INJECTION AP RS 1987-03-09 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A070010-001 AMINOCAPROIC ACID IN PLASTIC CONTAINER 250MG/ML INJECTABLE / INJECTION AP RS 1987-03-09 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A070010-001 AMINOCAPROIC ACID IN PLASTIC CONTAINER 250MG/ML INJECTABLE / INJECTION AP RS 1987-03-09 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A070010-001 AMINOCAPROIC ACID IN PLASTIC CONTAINER 250MG/ML INJECTABLE / INJECTION AP RS 1987-03-09 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A070010-001 AMINOCAPROIC ACID IN PLASTIC CONTAINER 250MG/ML INJECTABLE / INJECTION AP RS 1987-03-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A070010-001 AMINOCAPROIC ACID IN PLASTIC CONTAINER 250MG/ML INJECTABLE / INJECTION AP RS 1987-03-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A070010-001 AMINOCAPROIC ACID IN PLASTIC CONTAINER 250MG/ML INJECTABLE / INJECTION AP RS 1987-03-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A070010-001 AMINOCAPROIC ACID IN PLASTIC CONTAINER 250MG/ML INJECTABLE / INJECTION AP RS 1987-03-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A070010-001 AMINOCAPROIC ACID IN PLASTIC CONTAINER 250MG/ML INJECTABLE / INJECTION AP RS 1987-03-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A070010-001 AMINOCAPROIC ACID IN PLASTIC CONTAINER 250MG/ML INJECTABLE / INJECTION AP RS 1987-03-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A070010-001 AMINOCAPROIC ACID IN PLASTIC CONTAINER 250MG/ML INJECTABLE / INJECTION AP RS 1987-03-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A070010-001 AMINOCAPROIC ACID IN PLASTIC CONTAINER 250MG/ML INJECTABLE / INJECTION AP RS 1987-03-09 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A070010-001 AMINOCAPROIC ACID IN PLASTIC CONTAINER 250MG/ML INJECTABLE / INJECTION AP RS 1987-03-09 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A070010-001 AMINOCAPROIC ACID IN PLASTIC CONTAINER 250MG/ML INJECTABLE / INJECTION AP RS 1987-03-09 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A070010-001 AMINOCAPROIC ACID IN PLASTIC CONTAINER 250MG/ML INJECTABLE / INJECTION AP RS 1987-03-09 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A070010-001 AMINOCAPROIC ACID IN PLASTIC CONTAINER 250MG/ML INJECTABLE / INJECTION AP RS 1987-03-09 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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 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 1718760 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 0409-4346-16 Aminocaproic Acid 20 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 20 20 0409-4346-73 Aminocaproic Acid 25 in 1 TRAY INJECTION, SOLUTION 25 20
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AMINOCAPROIC ACID ACTIVE INGREDIENT U6F3787206 AMINOCAPROIC ACID INJECTION, SOLUTION [HOSPIRA, INC.] 11 AMINOCAPROIC ACID ACTIVE MOIETY U6F3787206 AMINOCAPROIC ACID INJECTION, SOLUTION [HOSPIRA, INC.] 11 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB AMINOCAPROIC ACID INJECTION, SOLUTION [HOSPIRA, INC.] 11 WATER INACTIVE INGREDIENT 059QF0KO0R AMINOCAPROIC ACID INJECTION, SOLUTION [HOSPIRA, INC.] 11 AMINOCAPROIC ACID ACTIVE INGREDIENT U6F3787206 AMINOCAPROIC ACID INJECTION, SOLUTION [HOSPIRA, INC.] 1 AMINOCAPROIC ACID ACTIVE MOIETY U6F3787206 AMINOCAPROIC ACID INJECTION, SOLUTION [HOSPIRA, INC.] 1 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB AMINOCAPROIC ACID INJECTION, SOLUTION [HOSPIRA, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R AMINOCAPROIC ACID INJECTION, SOLUTION [HOSPIRA, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0409-4346 AMINOCAPROIC ACID INJECTION, SOLUTION [HOSPIRA, INC.] 18 Current NDC, Legacy NDC, 2 package rows 20241210_1c5bc1dd-e9ec-44c1-9281-67ad482315d9.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 · 3 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 0409-4346-16 00409434616 20 mL in 1 VIAL, SINGLE-DOSE 20 ml Historical 0409-4346-73 00409434673 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-4346-73) / 20 mL in 1 VIAL, SINGLE-DOSE (0409-4346-16) 2010-05-12 0000-00-00 No No Current