Home NDC 52817-815-08 Aminocaproic acid
Product NDC 52817-815
Requested package NDC 52817-815-08
11-digit product format 528170815
Labeler code 52817
Product ID 52817-815_edabc3ff-6801-0067-e053-2a95a90ac024
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Aminocaproic Acid
Dosage form SOLUTION
Route ORAL
Labeler TruPharma LLC
Application ANDA212494
Marketing category ANDA
Marketing start 2020-09-25
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 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 A212494-001 AMINOCAPROIC ACID AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA RS 2020-08-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A212494-001 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 2026-02-19 14:30 UTC 2026-02 A212494-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA RS 2020-08-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212494-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA RS 2020-08-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212494-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA RS 2020-08-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212494-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA RS 2020-08-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212494-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA RS 2020-08-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212494-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA RS 2020-08-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212494-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA RS 2020-08-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212494-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA RS 2020-08-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212494-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA RS 2020-08-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212494-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA RS 2020-08-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212494-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA RS 2020-08-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212494-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA RS 2020-08-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212494-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA RS 2020-08-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212494-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA RS 2020-08-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212494-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2020-08-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A212494-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2020-08-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A212494-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2020-08-11 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A212494-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2020-08-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A212494-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2020-08-11 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A212494-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2020-08-11 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A212494-001 AMINOCAPROIC ACID 1.25GM/5ML SYRUP / ORAL AA 2020-08-11 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A212494-001 AMINOCAPROIC ACID 1.25GM/5ML SYRUP / ORAL AA 2020-08-11 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A212494-001 AMINOCAPROIC ACID 1.25GM/5ML SYRUP / ORAL AA 2020-08-11 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212494-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2020-08-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212494-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2020-08-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A212494-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2020-08-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212494-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2020-08-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A212494-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2020-08-11 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A212494-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2020-08-11 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A212494-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2020-08-11 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A212494-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2020-08-11 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A212494-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2020-08-11 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A212494-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2020-08-11 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A212494-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2020-08-11 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A212494-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2020-08-11 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A212494-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2020-08-11 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212494-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA RS 2020-08-11 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 52817-815-08 Aminocaproic acid 236.5 mL in 1 BOTTLE, PLASTIC SOLUTION 236.5 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52817-815 AMINOCAPROIC ACID SOLUTION [TRUPHARMA LLC] 4 Current NDC, Legacy NDC, 1 package rows 20221118_afffd309-3819-07c6-e053-2995a90a948b.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 · 1 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 52817-815-08 52817081508 236.5 mL in 1 BOTTLE, PLASTIC (52817-815-08) 236.5 ml 2020-09-25 0000-00-00 No No Current