Home NDC 0409-4346-73 Aminocaproic Acid
Product NDC 0409-4346
Requested package NDC 0409-4346-73
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 · 43 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 2026-09-14 22:38:34 2026-08 A070010-001 AMINOCAPROIC ACID IN PLASTIC CONTAINER 250MG/ML INJECTABLE / INJECTION AP RS 1987-03-09 84e616aacf4f…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 Marketing start Marketing end Sample Exclude flag Status 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