Home NDC 69238-1596 Aminocaproic acid
Product NDC 69238-1596
11-digit product format 692381596
Labeler code 69238
Product ID 69238-1596_2b9785d5-ea90-465b-a9f5-2c70e578799a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Aminocaproic acid
Dosage form SOLUTION
Route ORAL
Labeler Amneal Pharmaceuticals NY LLC
Application ANDA212780
Marketing category ANDA
Marketing start 2019-08-23
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 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 A212780-001 AMINOCAPROIC ACID AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2019-08-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A212780-001 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.
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 2026-08-18 06:07:40 2026-07 A212780-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2019-08-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212780-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2019-08-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212780-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2019-08-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212780-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2019-08-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212780-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2019-08-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212780-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2019-08-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212780-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2019-08-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212780-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2019-08-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212780-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2019-08-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212780-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2019-08-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212780-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2019-08-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212780-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2019-08-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212780-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2019-08-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212780-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2019-08-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212780-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2019-08-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212780-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2019-08-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A212780-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2019-08-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A212780-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2019-08-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A212780-001 AMINOCAPROIC ACID 1.25GM/5ML SYRUP / ORAL AA 2019-08-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A212780-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2019-08-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A212780-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2019-08-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A212780-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2019-08-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A212780-001 AMINOCAPROIC ACID 1.25GM/5ML SYRUP / ORAL AA 2019-08-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A212780-001 AMINOCAPROIC ACID 1.25GM/5ML SYRUP / ORAL AA 2019-08-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A212780-001 AMINOCAPROIC ACID 1.25GM/5ML SYRUP / ORAL AA 2019-08-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A212780-001 AMINOCAPROIC ACID 1.25GM/5ML SYRUP / ORAL AA 2019-08-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A212780-001 AMINOCAPROIC ACID 1.25GM/5ML SYRUP / ORAL AA 2019-08-23 b00525d2431f…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212780-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2019-08-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212780-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2019-08-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A212780-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2019-08-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212780-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2019-08-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A212780-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2019-08-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A212780-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2019-08-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A212780-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2019-08-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A212780-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2019-08-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A212780-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2019-08-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A212780-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2019-08-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A212780-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2019-08-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A212780-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2019-08-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A212780-001 AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 2019-08-23 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Observed Orange Book exclusivity 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 69238-1596-3 Aminocaproic acid 5 mL in 1 CUP, UNIT-DOSE SOLUTION 5 13 69238-1596-4 Aminocaproic acid 10 in 1 TRAY SOLUTION 10 13 69238-1596-8 Aminocaproic acid 236.5 mL in 1 BOTTLE, PLASTIC SOLUTION 236.5 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69238-1596 AMINOCAPROIC ACID SOLUTION [AMNEAL PHARMACEUTICALS NY LLC] 13 Current NDC, Legacy NDC, 3 package rows 20230505_65efb08a-c1ae-4bb7-a8a2-b7ae26485567.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 69238-1596-3 69238159603 5 mL in 1 CUP, UNIT-DOSE 5 ml Historical 69238-1596-4 69238159604 10 CUP, UNIT-DOSE in 1 TRAY (69238-1596-4) / 5 mL in 1 CUP, UNIT-DOSE (69238-1596-3) 2019-08-23 0000-00-00 No No Current 69238-1596-8 69238159608 236.5 mL in 1 BOTTLE, PLASTIC (69238-1596-8) 236.5 ml 2019-08-23 0000-00-00 No No Current