AMINOCAPROIC ACID

Product NDC
72162-2646
11-digit product format
721622646
Labeler code
72162
Product ID
72162-2646_184b740d-4fe3-46d8-83a7-5b6b54cf45e9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMINOCAPROIC ACID
Dosage form
SOLUTION
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA214140
Marketing category
ANDA
Marketing start
2021-03-18
Substance
AMINOCAPROIC ACID
Active strength
.25 g/mL
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A214140-001AMINOCAPROIC ACIDAMINOCAPROIC ACID0.25GM/MLSOLUTION / ORALAA2021-01-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A214140-001AA

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 06:07:402026-07A214140-001AMINOCAPROIC ACID0.25GM/MLSOLUTION / ORALAA2021-01-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214140-001AMINOCAPROIC ACID0.25GM/MLSOLUTION / ORALAA2021-01-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214140-001AMINOCAPROIC ACID0.25GM/MLSOLUTION / ORALAA2021-01-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A214140-001AMINOCAPROIC ACID0.25GM/MLSOLUTION / ORALAA2021-01-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214140-001AMINOCAPROIC ACID0.25GM/MLSOLUTION / ORALAA2021-01-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214140-001AMINOCAPROIC ACID0.25GM/MLSOLUTION / ORALAA2021-01-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214140-001AMINOCAPROIC ACID0.25GM/MLSOLUTION / ORALAA2021-01-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214140-001AMINOCAPROIC ACID0.25GM/MLSOLUTION / ORALAA2021-01-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214140-001AMINOCAPROIC ACID0.25GM/MLSOLUTION / ORALAA2021-01-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214140-001AMINOCAPROIC ACID0.25GM/MLSOLUTION / ORALAA2021-01-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214140-001AMINOCAPROIC ACID0.25GM/MLSOLUTION / ORALAA2021-01-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214140-001AMINOCAPROIC ACID0.25GM/MLSOLUTION / ORALAA2021-01-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214140-001AMINOCAPROIC ACID0.25GM/MLSOLUTION / ORALAA2021-01-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214140-001AMINOCAPROIC ACID0.25GM/MLSOLUTION / ORALAA2021-01-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214140-001AMINOCAPROIC ACID0.25GM/MLSOLUTION / ORALAA2021-01-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A214140-001AMINOCAPROIC ACID0.25GM/MLSOLUTION / ORALAA2021-01-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A214140-001AMINOCAPROIC ACID0.25GM/MLSOLUTION / ORALAA2021-01-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A214140-001AMINOCAPROIC ACID0.25GM/MLSOLUTION / ORALAA2021-01-264b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A214140-001AMINOCAPROIC ACID0.25GM/MLSOLUTION / ORALAA2021-01-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A214140-001AMINOCAPROIC ACID0.25GM/MLSOLUTION / ORALAA2021-01-26782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A214140-001AMINOCAPROIC ACID0.25GM/MLSOLUTION / ORALAA2021-01-2687673890dc5c…
2021-03-12 10:30 UTC2021-03A214140-001AMINOCAPROIC ACID1.25GM/5MLSYRUP / ORALAA2021-01-265aa47cf7b7d7…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214140-001AMINOCAPROIC ACID0.25GM/MLSOLUTION / ORALAA2021-01-266a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A214140-001AMINOCAPROIC ACID0.25GM/MLSOLUTION / ORALAA2021-01-261c564ffb4f44…
2023-12-20 04:57 UTC2023-12A214140-001AMINOCAPROIC ACID0.25GM/MLSOLUTION / ORALAA2021-01-26ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A214140-001AMINOCAPROIC ACID0.25GM/MLSOLUTION / ORALAA2021-01-26a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A214140-001AMINOCAPROIC ACID0.25GM/MLSOLUTION / ORALAA2021-01-269b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A214140-001AMINOCAPROIC ACID0.25GM/MLSOLUTION / ORALAA2021-01-26a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A214140-001AMINOCAPROIC ACID0.25GM/MLSOLUTION / ORALAA2021-01-263f0d92c62455…
2023-05-13 08:27 UTC2023-05A214140-001AMINOCAPROIC ACID0.25GM/MLSOLUTION / ORALAA2021-01-26053a50430f4f…
2023-01-26 05:58 UTC2023-01A214140-001AMINOCAPROIC ACID0.25GM/MLSOLUTION / ORALAA2021-01-263bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A214140-001AMINOCAPROIC ACID0.25GM/MLSOLUTION / ORALAA2021-01-263a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A214140-001AMINOCAPROIC ACID0.25GM/MLSOLUTION / ORALAA2021-01-26f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A214140-001AMINOCAPROIC ACID0.25GM/MLSOLUTION / ORALAA2021-01-26e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A214140-001AMINOCAPROIC ACID0.25GM/MLSOLUTION / ORALAA2021-01-26cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214140-001AMINOCAPROIC ACID0.25GM/MLSOLUTION / ORALAA2021-01-26a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A214140-001AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214140-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214140-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A214140-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214140-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214140-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214140-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214140-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214140-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214140-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214140-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214140-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214140-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214140-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214140-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A214140-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A214140-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A214140-001AA14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A214140-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A214140-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A214140-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A214140-001AA15aa47cf7b7d7…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214140-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A214140-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A214140-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A214140-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A214140-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A214140-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A214140-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A214140-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A214140-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A214140-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A214140-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A214140-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A214140-001AA1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214140-001AA1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
AMINOCAPROIC ACID
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMINOCAPROIC ACID.25 g/mL

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
582299Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c2144bf8-1a26-4958-ba10-5358bd69cd23Available 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
72162-2646-2AMINOCAPROIC ACID236.5 mL in 1 BOTTLESOLUTION236.5100

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AMINOCAPROIC ACIDAMINOCAPROIC ACIDBryant Ranch Prepackc2144bf8-1a26-4958-ba10-5358bd69cd232026-05-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214140
application number: ANDA214140
ndc (product): 72162-2646
AMINOCAPROIC ACIDAMINOCAPROIC ACIDCarnegie Pharmaceuticals, LLC0d6560a3-c67e-428e-b9b8-fab538856b412024-03-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214140
application number: ANDA214140
AMINOCAPROIC ACIDAMINOCAPROIC ACIDBiocon Pharma Inc.c3cadb3a-4f63-06ee-0dd2-6828dbc1fffa2021-01-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214140
application number: ANDA214140

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
582299aminocaproic acid 0.25 GM/mL Oral SolutionPSNc2144bf8-1a26-4958-ba10-5358bd69cd23100
5822996-aminocaproic acid 250 MG/ML Oral SolutionSCDc2144bf8-1a26-4958-ba10-5358bd69cd23100
5822996-aminocaproic acid 0.25 GM per ML Oral SyrupSYc2144bf8-1a26-4958-ba10-5358bd69cd23100
5822996-aminocaproic acid 1.25 GM per 5 ML Oral SyrupSYc2144bf8-1a26-4958-ba10-5358bd69cd23100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2646-272162264602236.5 mL in 1 BOTTLE (72162-2646-2) 236.5 ml2026-05-19NoNoCurrent