FDA.reportPublic FDA data

Aminocaproic Acid

Product NDC
62559-225
Requested package NDC
62559-225-30
11-digit product format
625590225
Labeler code
62559
Product ID
62559-225_69d62441-f780-44a9-91aa-43d3285b5b34
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aminocaproic Acid
Dosage form
TABLET
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
ANDA211629
Marketing category
ANDA
Marketing start
2020-12-16
Marketing end
0000-00-00
Substance
AMINOCAPROIC ACID
Active strength
500 mg/1
Pharmacologic classes
Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage62559-22562559-225-30DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage62559-22562559-225-30DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211629-001AMINOCAPROIC ACIDAMINOCAPROIC ACID500MGTABLET / ORAL2020-12-14

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A211629-001AMINOCAPROIC ACID500MGTABLET / ORAL2020-12-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211629-001AMINOCAPROIC ACID500MGTABLET / ORAL2020-12-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211629-001AMINOCAPROIC ACID500MGTABLET / ORAL2020-12-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A211629-001AMINOCAPROIC ACID500MGTABLET / ORAL2020-12-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211629-001AMINOCAPROIC ACID500MGTABLET / ORAL2020-12-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211629-001AMINOCAPROIC ACID500MGTABLET / ORAL2020-12-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211629-001AMINOCAPROIC ACID500MGTABLET / ORAL2020-12-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211629-001AMINOCAPROIC ACID500MGTABLET / ORALAB2020-12-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211629-001AMINOCAPROIC ACID500MGTABLET / ORALAB2020-12-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211629-001AMINOCAPROIC ACID500MGTABLET / ORALAB2020-12-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211629-001AMINOCAPROIC ACID500MGTABLET / ORALAB2020-12-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211629-001AMINOCAPROIC ACID500MGTABLET / ORALAB2020-12-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211629-001AMINOCAPROIC ACID500MGTABLET / ORALAB2020-12-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211629-001AMINOCAPROIC ACID500MGTABLET / ORALAB2020-12-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211629-001AMINOCAPROIC ACID500MGTABLET / ORALAB2020-12-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211629-001AMINOCAPROIC ACID500MGTABLET / ORALAB2020-12-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211629-001AMINOCAPROIC ACID500MGTABLET / ORALAB2020-12-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211629-001AMINOCAPROIC ACID500MGTABLET / ORALAB2020-12-144b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A211629-001AMINOCAPROIC ACID500MGTABLET / ORALAB2020-12-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211629-001AMINOCAPROIC ACID500MGTABLET / ORALAB2020-12-14782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A211629-001AMINOCAPROIC ACID500MGTABLET / ORALAB2020-12-1487673890dc5c…
2021-03-12 10:30 UTC2021-03A211629-001AMINOCAPROIC ACID500MGTABLET / ORALAB2020-12-145aa47cf7b7d7…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211629-001AMINOCAPROIC ACID500MGTABLET / ORALAB2020-12-146a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211629-001AMINOCAPROIC ACID500MGTABLET / ORALAB2020-12-141c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211629-001AMINOCAPROIC ACID500MGTABLET / ORALAB2020-12-14ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211629-001AMINOCAPROIC ACID500MGTABLET / ORALAB2020-12-14a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211629-001AMINOCAPROIC ACID500MGTABLET / ORALAB2020-12-149b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211629-001AMINOCAPROIC ACID500MGTABLET / ORALAB2020-12-14a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211629-001AMINOCAPROIC ACID500MGTABLET / ORALAB2020-12-143f0d92c62455…
2023-05-13 08:27 UTC2023-05A211629-001AMINOCAPROIC ACID500MGTABLET / ORALAB2020-12-14053a50430f4f…
2023-01-26 05:58 UTC2023-01A211629-001AMINOCAPROIC ACID500MGTABLET / ORALAB2020-12-143bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211629-001AMINOCAPROIC ACID500MGTABLET / ORALAB2020-12-143a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211629-001AMINOCAPROIC ACID500MGTABLET / ORALAB2020-12-14f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A211629-001AMINOCAPROIC ACID500MGTABLET / ORALAB2020-12-14e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A211629-001AMINOCAPROIC ACID500MGTABLET / ORALAB2020-12-14cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211629-001AMINOCAPROIC ACID500MGTABLET / ORAL2020-12-14a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211629-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211629-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211629-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211629-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211629-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211629-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211629-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211629-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211629-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211629-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211629-001AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A211629-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211629-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A211629-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A211629-001AB15aa47cf7b7d7…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211629-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211629-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211629-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211629-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211629-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211629-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211629-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A211629-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A211629-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211629-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211629-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A211629-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A211629-001AB1cb3db0bc1861…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62559-225-30EA - Each62559-225a2ff2617-af6b-4c7b-a66f-c1aaec0d301412021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62559-225AMINOCAPROIC ACID TABLET [ANI PHARMACEUTICALS, INC.]3Legacy NDC20241116_73bbf009-b07d-49df-b548-721a6451d9e3.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62559-225-306255902253030 TABLET in 1 BOTTLE (62559-225-30) 30 tablet2020-12-160000-00-00NoNoCurrent