Home NDC 81033-033 Aminocaproic acid
Product NDC 81033-033
11-digit product format 810330033
Labeler code 81033
Product ID 81033-033_5e5ebfc9-20ff-e655-e063-6294a90a6d95
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Aminocaproic acid
Dosage form TABLET
Route ORAL
Labeler Kesin Pharma Corporation
Application ANDA212938
Marketing category ANDA
Marketing start 2020-12-10
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 A212938-001 AMINOCAPROIC ACID AMINOCAPROIC ACID 500MG TABLET / ORAL AB 2020-11-06 A212938-002 AMINOCAPROIC ACID AMINOCAPROIC ACID 1GM TABLET / ORAL AB 2023-09-13
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 · 62 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 A212938-001 AMINOCAPROIC ACID 500MG TABLET / ORAL AB 2020-11-06 c2088c7a36db…2026-10-15 13:18:30 2026-09 A212938-002 AMINOCAPROIC ACID 1GM TABLET / ORAL AB 2023-09-13 c2088c7a36db…2026-09-14 22:38:34 2026-08 A212938-001 AMINOCAPROIC ACID 500MG TABLET / ORAL AB 2020-11-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A212938-002 AMINOCAPROIC ACID 1GM TABLET / ORAL AB 2023-09-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 A212938-001 AMINOCAPROIC ACID 500MG TABLET / ORAL AB 2020-11-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A212938-002 AMINOCAPROIC ACID 1GM TABLET / ORAL AB 2023-09-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212938-001 AMINOCAPROIC ACID 500MG TABLET / ORAL AB 2020-11-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212938-002 AMINOCAPROIC ACID 1GM TABLET / ORAL AB 2023-09-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212938-001 AMINOCAPROIC ACID 500MG TABLET / ORAL AB 2020-11-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212938-002 AMINOCAPROIC ACID 1GM TABLET / ORAL AB 2023-09-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212938-001 AMINOCAPROIC ACID 500MG TABLET / ORAL AB 2020-11-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212938-002 AMINOCAPROIC ACID 1GM TABLET / ORAL AB 2023-09-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212938-001 AMINOCAPROIC ACID 500MG TABLET / ORAL AB 2020-11-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212938-002 AMINOCAPROIC ACID 1GM TABLET / ORAL AB 2023-09-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212938-001 AMINOCAPROIC ACID 500MG TABLET / ORAL AB 2020-11-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212938-002 AMINOCAPROIC ACID 1GM TABLET / ORAL AB 2023-09-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212938-001 AMINOCAPROIC ACID 500MG TABLET / ORAL AB 2020-11-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212938-002 AMINOCAPROIC ACID 1GM TABLET / ORAL AB 2023-09-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212938-001 AMINOCAPROIC ACID 500MG TABLET / ORAL AB 2020-11-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212938-002 AMINOCAPROIC ACID 1GM TABLET / ORAL AB 2023-09-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212938-001 AMINOCAPROIC ACID 500MG TABLET / ORAL AB 2020-11-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212938-002 AMINOCAPROIC ACID 1GM TABLET / ORAL AB 2023-09-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212938-001 AMINOCAPROIC ACID 500MG TABLET / ORAL AB 2020-11-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212938-002 AMINOCAPROIC ACID 1GM TABLET / ORAL AB 2023-09-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212938-001 AMINOCAPROIC ACID 500MG TABLET / ORAL AB 2020-11-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212938-002 AMINOCAPROIC ACID 1GM TABLET / ORAL AB 2023-09-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212938-001 AMINOCAPROIC ACID 500MG TABLET / ORAL AB 2020-11-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212938-002 AMINOCAPROIC ACID 1GM TABLET / ORAL AB 2023-09-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212938-001 AMINOCAPROIC ACID 500MG TABLET / ORAL AB 2020-11-06 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212938-002 AMINOCAPROIC ACID 1GM TABLET / ORAL AB 2023-09-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212938-001 AMINOCAPROIC ACID 500MG TABLET / ORAL AB 2020-11-06 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212938-002 AMINOCAPROIC ACID 1GM TABLET / ORAL AB 2023-09-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212938-001 AMINOCAPROIC ACID 500MG TABLET / ORAL AB 2020-11-06 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A212938-002 AMINOCAPROIC ACID 1GM TABLET / ORAL AB 2023-09-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212938-001 AMINOCAPROIC ACID 500MG TABLET / ORAL AB 2020-11-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A212938-001 AMINOCAPROIC ACID 500MG TABLET / ORAL AB 2020-11-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A212938-001 AMINOCAPROIC ACID 500MG TABLET / ORAL AB 2020-11-06 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A212938-001 AMINOCAPROIC ACID 500MG TABLET / ORAL AB 2020-11-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A212938-001 AMINOCAPROIC ACID 500MG TABLET / ORAL AB 2020-11-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A212938-001 AMINOCAPROIC ACID 500MG TABLET / ORAL AB 2020-11-06 87673890dc5c…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 2 · 62 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
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 81033-033-31 81033003331 3 BLISTER PACK in 1 CARTON (81033-033-31) / 30 TABLET in 1 BLISTER PACK (81033-033-51) 3 blister pack 2026-11-02 No No Current