Aminocaproic Acid

Product NDC
60687-739
11-digit product format
606870739
Labeler code
60687
Product ID
60687-739_522e200a-159f-381b-e063-6394a90ada80
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aminocaproic Acid
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA209060
Marketing category
ANDA
Marketing start
2023-03-10
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 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209060-001AMINOCAPROIC ACIDAMINOCAPROIC ACID500MGTABLET / ORALAB2018-11-27
A209060-002AMINOCAPROIC ACIDAMINOCAPROIC ACID1GMTABLET / ORALABRS2018-11-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A209060-001AB
A209060-002AB

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 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A209060-001AMINOCAPROIC ACID500MGTABLET / ORALAB2018-11-27caaa826d4ba7…
2026-08-18 06:07:402026-07A209060-002AMINOCAPROIC ACID1GMTABLET / ORALABRS2018-11-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209060-001AMINOCAPROIC ACID500MGTABLET / ORALAB2018-11-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209060-002AMINOCAPROIC ACID1GMTABLET / ORALABRS2018-11-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209060-001AMINOCAPROIC ACID500MGTABLET / ORALAB2018-11-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209060-002AMINOCAPROIC ACID1GMTABLET / ORALABRS2018-11-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A209060-001AMINOCAPROIC ACID500MGTABLET / ORALAB2018-11-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209060-002AMINOCAPROIC ACID1GMTABLET / ORALABRS2018-11-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209060-001AMINOCAPROIC ACID500MGTABLET / ORALAB2018-11-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209060-002AMINOCAPROIC ACID1GMTABLET / ORALABRS2018-11-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209060-001AMINOCAPROIC ACID500MGTABLET / ORALAB2018-11-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209060-002AMINOCAPROIC ACID1GMTABLET / ORALABRS2018-11-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209060-001AMINOCAPROIC ACID500MGTABLET / ORALAB2018-11-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209060-002AMINOCAPROIC ACID1GMTABLET / ORALABRS2018-11-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209060-001AMINOCAPROIC ACID500MGTABLET / ORALAB2018-11-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209060-002AMINOCAPROIC ACID1GMTABLET / ORALABRS2018-11-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209060-001AMINOCAPROIC ACID500MGTABLET / ORALAB2018-11-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209060-002AMINOCAPROIC ACID1GMTABLET / ORALABRS2018-11-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209060-001AMINOCAPROIC ACID500MGTABLET / ORALAB2018-11-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209060-002AMINOCAPROIC ACID1GMTABLET / ORALABRS2018-11-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209060-001AMINOCAPROIC ACID500MGTABLET / ORALAB2018-11-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A209060-002AMINOCAPROIC ACID1GMTABLET / ORALABRS2018-11-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209060-001AMINOCAPROIC ACID500MGTABLET / ORALAB2018-11-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209060-002AMINOCAPROIC ACID1GMTABLET / ORALABRS2018-11-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209060-001AMINOCAPROIC ACID500MGTABLET / ORALAB2018-11-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209060-002AMINOCAPROIC ACID1GMTABLET / ORALABRS2018-11-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209060-001AMINOCAPROIC ACID500MGTABLET / ORALAB2018-11-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209060-002AMINOCAPROIC ACID1GMTABLET / ORALABRS2018-11-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209060-001AMINOCAPROIC ACID500MGTABLET / ORALAB2018-11-278072bd15b7f6…
2024-05-31 18:47 UTC2024-05A209060-002AMINOCAPROIC ACID1GMTABLET / ORALABRS2018-11-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209060-001AMINOCAPROIC ACID500MGTABLET / ORALAB2018-11-275c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209060-002AMINOCAPROIC ACID1GMTABLET / ORALABRS2018-11-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209060-001AMINOCAPROIC ACID500MGTABLET / ORALAB2018-11-275d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A209060-002AMINOCAPROIC ACID1GMTABLET / ORALABRS2018-11-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209060-001AMINOCAPROIC ACID500MGTABLET / ORALAB2018-11-274b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A209060-002AMINOCAPROIC ACID1GMTABLET / ORALABRS2018-11-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209060-001AMINOCAPROIC ACID500MGTABLET / ORALAB2018-11-2774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A209060-002AMINOCAPROIC ACID1GMTABLET / ORALABRS2018-11-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209060-001AMINOCAPROIC ACID500MGTABLET / ORALAB2018-11-27bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A209060-002AMINOCAPROIC ACID1GMTABLET / ORALABRS2018-11-27bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A209060-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209060-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209060-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209060-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209060-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209060-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209060-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209060-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209060-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209060-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209060-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209060-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209060-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209060-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209060-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209060-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209060-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209060-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209060-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209060-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209060-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A209060-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209060-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209060-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209060-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209060-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209060-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209060-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209060-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A209060-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209060-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209060-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209060-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A209060-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209060-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A209060-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209060-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A209060-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209060-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A209060-002AB1bb7c543d1eb4…

Additional Listing Data#

Finished product
Yes
Brand name base
Aminocaproic Acid
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMINOCAPROIC ACID500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
U6F3787206Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197351Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4c2612ab-86a4-4c54-a5c0-e837f755965fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
83904ae6-37b6-4aa3-b6c9-663bc8d6ab8dProduct name920250103
e89c33e6-9224-49b0-4d80-05239f586f24Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60687-739-25Aminocaproic Acid30 in 1 CARTONTABLET304
60687-739-95Aminocaproic Acid1 in 1 BLISTER PACKTABLET14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-739-25EA - Each60687-739794e967b-e65e-4083-8923-d9623061338712023-04-07
60687-739-95EA - Each60687-7395c950df1-b9ff-46a3-bfb9-f6e6ca8674cb12023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-739AMINOCAPROIC ACID TABLET [AMERICAN HEALTH PACKAGING]2Current NDC, 2 package rows20241024_4c2612ab-86a4-4c54-a5c0-e837f755965f.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aminocaproic AcidAMINOCAPROIC ACIDAmerican Health Packaging4c2612ab-86a4-4c54-a5c0-e837f755965f2026-05-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209060
application number: ANDA209060
ndc (product): 60687-739
Aminocaproic AcidAMINOCAPROIC ACIDVitruvias Therapeutics555a0910-dbeb-4643-8b3a-c9fe9b803b3c2021-03-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209060
application number: ANDA209060

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197351aminocaproic acid 500 MG Oral TabletPSN4c2612ab-86a4-4c54-a5c0-e837f755965f4
1973516-aminocaproic acid 500 MG Oral TabletSCD4c2612ab-86a4-4c54-a5c0-e837f755965f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60687-739-256068707392530 BLISTER PACK in 1 CARTON (60687-739-25) / 1 TABLET in 1 BLISTER PACK (60687-739-95) 30 blister pack2023-03-10NoNoCurrent
60687-739-95606870739951 in 1 BLISTER PACKHistorical