Home NDC 16571-326 Aminocaproic Acid
Product NDC 16571-326
11-digit product format 165710326
Labeler code 16571
Product ID 16571-326_c9542474-b523-4bf0-966e-3ce9fe35a0a2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Aminocaproic Acid
Dosage form TABLET
Route ORAL
Labeler RISING PHARMA HOLDINGS, INC.
Application ANDA213944
Marketing category ANDA
Marketing start 2026-09-20
Substance AMINOCAPROIC ACID
Active strength 500 mg/1
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 44 .
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 A213944-001 AMINOCAPROIC ACID AMINOCAPROIC ACID 500MG TABLET / ORAL AB 2022-09-14 A213944-002 AMINOCAPROIC ACID AMINOCAPROIC ACID 1GM TABLET / ORAL AB 2022-09-14
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 2 · 58 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 2026-10-15 13:18:30 2026-09 A213944-001 AMINOCAPROIC ACID 500MG TABLET / ORAL AB 2022-09-14 c2088c7a36db…2026-10-15 13:18:30 2026-09 A213944-002 AMINOCAPROIC ACID 1GM TABLET / ORAL AB 2022-09-14 c2088c7a36db…2026-09-14 22:38:34 2026-08 A213944-001 AMINOCAPROIC ACID 500MG TABLET / ORAL AB 2022-09-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 A213944-002 AMINOCAPROIC ACID 1GM TABLET / ORAL AB 2022-09-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 A213944-001 AMINOCAPROIC ACID 500MG TABLET / ORAL AB 2022-09-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213944-002 AMINOCAPROIC ACID 1GM TABLET / ORAL AB 2022-09-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213944-001 AMINOCAPROIC ACID 500MG TABLET / ORAL AB 2022-09-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213944-002 AMINOCAPROIC ACID 1GM TABLET / ORAL AB 2022-09-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213944-001 AMINOCAPROIC ACID 500MG TABLET / ORAL AB 2022-09-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213944-002 AMINOCAPROIC ACID 1GM TABLET / ORAL AB 2022-09-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213944-001 AMINOCAPROIC ACID 500MG TABLET / ORAL AB 2022-09-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213944-002 AMINOCAPROIC ACID 1GM TABLET / ORAL AB 2022-09-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213944-001 AMINOCAPROIC ACID 500MG TABLET / ORAL AB 2022-09-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213944-002 AMINOCAPROIC ACID 1GM TABLET / ORAL AB 2022-09-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213944-001 AMINOCAPROIC ACID 500MG TABLET / ORAL AB 2022-09-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213944-002 AMINOCAPROIC ACID 1GM TABLET / ORAL AB 2022-09-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213944-001 AMINOCAPROIC ACID 500MG TABLET / ORAL AB 2022-09-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213944-002 AMINOCAPROIC ACID 1GM TABLET / ORAL AB 2022-09-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213944-001 AMINOCAPROIC ACID 500MG TABLET / ORAL AB 2022-09-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213944-002 AMINOCAPROIC ACID 1GM TABLET / ORAL AB 2022-09-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213944-001 AMINOCAPROIC ACID 500MG TABLET / ORAL AB 2022-09-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213944-002 AMINOCAPROIC ACID 1GM TABLET / ORAL AB 2022-09-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213944-001 AMINOCAPROIC ACID 500MG TABLET / ORAL AB 2022-09-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213944-002 AMINOCAPROIC ACID 1GM TABLET / ORAL AB 2022-09-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213944-001 AMINOCAPROIC ACID 500MG TABLET / ORAL AB 2022-09-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213944-002 AMINOCAPROIC ACID 1GM TABLET / ORAL AB 2022-09-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213944-001 AMINOCAPROIC ACID 500MG TABLET / ORAL AB 2022-09-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213944-002 AMINOCAPROIC ACID 1GM TABLET / ORAL AB 2022-09-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213944-001 AMINOCAPROIC ACID 500MG TABLET / ORAL AB 2022-09-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213944-002 AMINOCAPROIC ACID 1GM TABLET / ORAL AB 2022-09-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213944-001 AMINOCAPROIC ACID 500MG TABLET / ORAL AB 2022-09-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213944-002 AMINOCAPROIC ACID 1GM TABLET / ORAL AB 2022-09-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213944-001 AMINOCAPROIC ACID 500MG TABLET / ORAL AB 2022-09-14 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A213944-002 AMINOCAPROIC ACID 1GM TABLET / ORAL AB 2022-09-14 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213944-001 AMINOCAPROIC ACID 500MG TABLET / ORAL AB 2022-09-14 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213944-002 AMINOCAPROIC ACID 1GM TABLET / ORAL AB 2022-09-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A213944-001 AMINOCAPROIC ACID 500MG TABLET / ORAL AB 2022-09-14 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A213944-002 AMINOCAPROIC ACID 1GM TABLET / ORAL AB 2022-09-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A213944-001 AMINOCAPROIC ACID 500MG TABLET / ORAL AB 2022-09-14 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A213944-002 AMINOCAPROIC ACID 1GM TABLET / ORAL AB 2022-09-14 ea1830bbd6c7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 58 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 500 mg/1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 16571-326-03 16571032603 30 TABLET in 1 BOTTLE (16571-326-03) 30 tablet 2026-09-20 No No Current