Aminocaproic Acid

Product NDC
61748-044
Requested package NDC
61748-044-08
11-digit product format
617480044
Labeler code
61748
Product ID
61748-044_e5ad3047-3a57-4f63-a99e-fc5ad4b5da63
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aminocaproic Acid
Dosage form
SYRUP
Route
ORAL
Labeler
Versapharm Incorporated
Application
ANDA074759
Marketing category
ANDA
Marketing start
2000-03-01
Marketing end
0000-00-00
Substance
AMINOCAPROIC ACID
Active strength
0 g/mL
Pharmacologic classes
Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE]
NDC exclude flag
No
Listing certified through
2021-12-31
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 packagepackage61748-04461748-044-08DDiscontinued 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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
A074759-001AMINOCAPROIC ACIDAMINOCAPROIC ACID0.25GM/MLSOLUTION / ORAL1998-09-02

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A074759-001AMINOCAPROIC ACID0.25GM/MLSOLUTION / ORAL1998-09-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074759-001AMINOCAPROIC ACID0.25GM/MLSOLUTION / ORAL1998-09-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074759-001AMINOCAPROIC ACID0.25GM/MLSOLUTION / ORAL1998-09-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A074759-001AMINOCAPROIC ACID0.25GM/MLSOLUTION / ORAL1998-09-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074759-001AMINOCAPROIC ACID0.25GM/MLSOLUTION / ORAL1998-09-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074759-001AMINOCAPROIC ACID0.25GM/MLSOLUTION / ORAL1998-09-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074759-001AMINOCAPROIC ACID0.25GM/MLSOLUTION / ORAL1998-09-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074759-001AMINOCAPROIC ACID0.25GM/MLSOLUTION / ORAL1998-09-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074759-001AMINOCAPROIC ACID0.25GM/MLSOLUTION / ORAL1998-09-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074759-001AMINOCAPROIC ACID0.25GM/MLSOLUTION / ORAL1998-09-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074759-001AMINOCAPROIC ACID0.25GM/MLSOLUTION / ORAL1998-09-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074759-001AMINOCAPROIC ACID0.25GM/MLSOLUTION / ORAL1998-09-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074759-001AMINOCAPROIC ACID0.25GM/MLSOLUTION / ORAL1998-09-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074759-001AMINOCAPROIC ACID0.25GM/MLSOLUTION / ORAL1998-09-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074759-001AMINOCAPROIC ACID0.25GM/MLSOLUTION / ORAL1998-09-028072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074759-001AMINOCAPROIC ACID0.25GM/MLSOLUTION / ORAL1998-09-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074759-001AMINOCAPROIC ACID0.25GM/MLSOLUTION / ORAL1998-09-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074759-001AMINOCAPROIC ACID0.25GM/MLSOLUTION / ORAL1998-09-024b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074759-001AMINOCAPROIC ACID1.25GM/5MLSYRUP / ORAL1998-09-0274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074759-001AMINOCAPROIC ACID0.25GM/MLSOLUTION / ORAL1998-09-02bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074759-001AMINOCAPROIC ACID0.25GM/MLSOLUTION / ORAL1998-09-02782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074759-001AMINOCAPROIC ACID0.25GM/MLSOLUTION / ORAL1998-09-0287673890dc5c…
2021-03-12 10:30 UTC2021-03A074759-001AMINOCAPROIC ACID1.25GM/5MLSYRUP / ORAL1998-09-025aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074759-001AMINOCAPROIC ACID1.25GM/5MLSYRUP / ORAL1998-09-028869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074759-001AMINOCAPROIC ACID1.25GM/5MLSYRUP / ORAL1998-09-02c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074759-001AMINOCAPROIC ACID1.25GM/5MLSYRUP / ORAL1998-09-023f01610625f2…
2019-09-15 20:21 UTC2019-09A074759-001AMINOCAPROIC ACID1.25GM/5MLSYRUP / ORAL1998-09-02b00525d2431f…
2019-07-19 19:46 UTC2019-07A074759-001AMINOCAPROIC ACID1.25GM/5MLSYRUP / ORAL1998-09-02ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074759-001AMINOCAPROIC ACID0.25GM/MLSOLUTION / ORAL1998-09-026a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074759-001AMINOCAPROIC ACID0.25GM/MLSOLUTION / ORAL1998-09-021c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074759-001AMINOCAPROIC ACID0.25GM/MLSOLUTION / ORAL1998-09-02ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074759-001AMINOCAPROIC ACID0.25GM/MLSOLUTION / ORAL1998-09-02a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074759-001AMINOCAPROIC ACID0.25GM/MLSOLUTION / ORAL1998-09-029b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074759-001AMINOCAPROIC ACID0.25GM/MLSOLUTION / ORAL1998-09-02a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074759-001AMINOCAPROIC ACID0.25GM/MLSOLUTION / ORAL1998-09-023f0d92c62455…
2023-05-13 08:27 UTC2023-05A074759-001AMINOCAPROIC ACID0.25GM/MLSOLUTION / ORAL1998-09-02053a50430f4f…
2023-01-26 05:58 UTC2023-01A074759-001AMINOCAPROIC ACID0.25GM/MLSOLUTION / ORAL1998-09-023bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074759-001AMINOCAPROIC ACID0.25GM/MLSOLUTION / ORAL1998-09-023a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074759-001AMINOCAPROIC ACID0.25GM/MLSOLUTION / ORAL1998-09-02f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074759-001AMINOCAPROIC ACID0.25GM/MLSOLUTION / ORAL1998-09-02e64feba35796…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61748-044-08ML - Milliliter61748-04480dfeb77-1f8d-4e37-94bb-2a51d0ef57a712012-07-24
61748-044-16ML - Milliliter61748-044a695680d-077e-43aa-a7e9-12168a62d6f512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMINOCAPROIC ACIDACTIVE INGREDIENTU6F3787206AMINOCAPROIC ACID TABLET AMINOCAPROIC ACID SYRUP [VERSAPHARM INCORPORATED]6
AMINOCAPROIC ACIDACTIVE MOIETYU6F3787206AMINOCAPROIC ACID TABLET AMINOCAPROIC ACID SYRUP [VERSAPHARM INCORPORATED]6
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLAMINOCAPROIC ACID TABLET AMINOCAPROIC ACID SYRUP [VERSAPHARM INCORPORATED]6
CROSPOVIDONEINACTIVE INGREDIENT68401960MKAMINOCAPROIC ACID TABLET AMINOCAPROIC ACID SYRUP [VERSAPHARM INCORPORATED]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMINOCAPROIC ACID TABLET AMINOCAPROIC ACID SYRUP [VERSAPHARM INCORPORATED]6
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TAMINOCAPROIC ACID TABLET AMINOCAPROIC ACID SYRUP [VERSAPHARM INCORPORATED]6
POVIDONESINACTIVE INGREDIENTFZ989GH94EAMINOCAPROIC ACID TABLET AMINOCAPROIC ACID SYRUP [VERSAPHARM INCORPORATED]6
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3AMINOCAPROIC ACID TABLET AMINOCAPROIC ACID SYRUP [VERSAPHARM INCORPORATED]6
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHAMINOCAPROIC ACID TABLET AMINOCAPROIC ACID SYRUP [VERSAPHARM INCORPORATED]6
RASPBERRYINACTIVE INGREDIENT4N14V5R27WAMINOCAPROIC ACID TABLET AMINOCAPROIC ACID SYRUP [VERSAPHARM INCORPORATED]6
SACCHARIN SODIUM ANHYDROUSINACTIVE INGREDIENTI4807BK602AMINOCAPROIC ACID TABLET AMINOCAPROIC ACID SYRUP [VERSAPHARM INCORPORATED]6
SORBITOLINACTIVE INGREDIENT506T60A25RAMINOCAPROIC ACID TABLET AMINOCAPROIC ACID SYRUP [VERSAPHARM INCORPORATED]6
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APAMINOCAPROIC ACID TABLET AMINOCAPROIC ACID SYRUP [VERSAPHARM INCORPORATED]6
WATERINACTIVE INGREDIENT059QF0KO0RAMINOCAPROIC ACID TABLET AMINOCAPROIC ACID SYRUP [VERSAPHARM INCORPORATED]6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61748-044-0861748004408237 mL in 1 BOTTLE, PLASTIC (61748-044-08) 237 ml2000-03-010000-00-00NoNoCurrent