Aminocaproic Acid

Product NDC
71872-7359
11-digit product format
718727359
Labeler code
71872
Product ID
71872-7359_4629d7c3-8a2c-46d6-e063-6294a90a7354
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMINOCAPROIC ACID
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Medical Purchasing Solutions, LLC
Application
ANDA070010
Marketing category
ANDA
Marketing start
2010-05-12
Substance
AMINOCAPROIC ACID
Active strength
250 mg/mL
Pharmacologic classes
Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
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
A070010-001AMINOCAPROIC ACID IN PLASTIC CONTAINERAMINOCAPROIC ACID250MG/MLINJECTABLE / INJECTIONAPRS1987-03-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A070010-001AP

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 06:07:402026-07A070010-001AMINOCAPROIC ACID IN PLASTIC CONTAINER250MG/MLINJECTABLE / INJECTIONAPRS1987-03-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A070010-001AMINOCAPROIC ACID IN PLASTIC CONTAINER250MG/MLINJECTABLE / INJECTIONAPRS1987-03-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070010-001AMINOCAPROIC ACID IN PLASTIC CONTAINER250MG/MLINJECTABLE / INJECTIONAPRS1987-03-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A070010-001AMINOCAPROIC ACID IN PLASTIC CONTAINER250MG/MLINJECTABLE / INJECTIONAPRS1987-03-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070010-001AMINOCAPROIC ACID IN PLASTIC CONTAINER250MG/MLINJECTABLE / INJECTIONAPRS1987-03-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070010-001AMINOCAPROIC ACID IN PLASTIC CONTAINER250MG/MLINJECTABLE / INJECTIONAPRS1987-03-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070010-001AMINOCAPROIC ACID IN PLASTIC CONTAINER250MG/MLINJECTABLE / INJECTIONAPRS1987-03-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070010-001AMINOCAPROIC ACID IN PLASTIC CONTAINER250MG/MLINJECTABLE / INJECTIONAPRS1987-03-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070010-001AMINOCAPROIC ACID IN PLASTIC CONTAINER250MG/MLINJECTABLE / INJECTIONAPRS1987-03-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070010-001AMINOCAPROIC ACID IN PLASTIC CONTAINER250MG/MLINJECTABLE / INJECTIONAPRS1987-03-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A070010-001AMINOCAPROIC ACID IN PLASTIC CONTAINER250MG/MLINJECTABLE / INJECTIONAPRS1987-03-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070010-001AMINOCAPROIC ACID IN PLASTIC CONTAINER250MG/MLINJECTABLE / INJECTIONAPRS1987-03-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070010-001AMINOCAPROIC ACID IN PLASTIC CONTAINER250MG/MLINJECTABLE / INJECTIONAPRS1987-03-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070010-001AMINOCAPROIC ACID IN PLASTIC CONTAINER250MG/MLINJECTABLE / INJECTIONAPRS1987-03-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A070010-001AMINOCAPROIC ACID IN PLASTIC CONTAINER250MG/MLINJECTABLE / INJECTIONAPRS1987-03-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A070010-001AMINOCAPROIC ACID IN PLASTIC CONTAINER250MG/MLINJECTABLE / INJECTIONAPRS1987-03-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A070010-001AMINOCAPROIC ACID IN PLASTIC CONTAINER250MG/MLINJECTABLE / INJECTIONAPRS1987-03-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A070010-001AMINOCAPROIC ACID IN PLASTIC CONTAINER250MG/MLINJECTABLE / INJECTIONAPRS1987-03-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A070010-001AMINOCAPROIC ACID IN PLASTIC CONTAINER250MG/MLINJECTABLE / INJECTIONAPRS1987-03-0974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A070010-001AMINOCAPROIC ACID IN PLASTIC CONTAINER250MG/MLINJECTABLE / INJECTIONAPRS1987-03-09bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A070010-001AMINOCAPROIC ACID IN PLASTIC CONTAINER250MG/MLINJECTABLE / INJECTIONAPRS1987-03-09782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A070010-001AMINOCAPROIC ACID IN PLASTIC CONTAINER250MG/MLINJECTABLE / INJECTIONAPRS1987-03-0987673890dc5c…
2021-03-12 10:30 UTC2021-03A070010-001AMINOCAPROIC ACID IN PLASTIC CONTAINER250MG/MLINJECTABLE / INJECTIONAPRS1987-03-095aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A070010-001AMINOCAPROIC ACID IN PLASTIC CONTAINER250MG/MLINJECTABLE / INJECTIONAPRS1987-03-098869cabd3fbd…
2020-11-12 02:37 UTC2020-11A070010-001AMINOCAPROIC ACID IN PLASTIC CONTAINER250MG/MLINJECTABLE / INJECTIONAPRS1987-03-09c0c555d07b60…
2019-12-14 00:12 UTC2019-12A070010-001AMINOCAPROIC ACID IN PLASTIC CONTAINER250MG/MLINJECTABLE / INJECTIONAPRS1987-03-093f01610625f2…
2019-09-15 20:21 UTC2019-09A070010-001AMINOCAPROIC ACID IN PLASTIC CONTAINER250MG/MLINJECTABLE / INJECTIONAPRS1987-03-09b00525d2431f…
2019-07-19 19:46 UTC2019-07A070010-001AMINOCAPROIC ACID IN PLASTIC CONTAINER250MG/MLINJECTABLE / INJECTIONAPRS1987-03-09ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A070010-001AMINOCAPROIC ACID IN PLASTIC CONTAINER250MG/MLINJECTABLE / INJECTIONAPRS1987-03-096a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A070010-001AMINOCAPROIC ACID IN PLASTIC CONTAINER250MG/MLINJECTABLE / INJECTIONAPRS1987-03-091c564ffb4f44…
2023-12-20 04:57 UTC2023-12A070010-001AMINOCAPROIC ACID IN PLASTIC CONTAINER250MG/MLINJECTABLE / INJECTIONAPRS1987-03-09ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A070010-001AMINOCAPROIC ACID IN PLASTIC CONTAINER250MG/MLINJECTABLE / INJECTIONAPRS1987-03-09a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A070010-001AMINOCAPROIC ACID IN PLASTIC CONTAINER250MG/MLINJECTABLE / INJECTIONAPRS1987-03-099b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A070010-001AMINOCAPROIC ACID IN PLASTIC CONTAINER250MG/MLINJECTABLE / INJECTIONAPRS1987-03-09a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A070010-001AMINOCAPROIC ACID IN PLASTIC CONTAINER250MG/MLINJECTABLE / INJECTIONAPRS1987-03-093f0d92c62455…
2023-05-13 08:27 UTC2023-05A070010-001AMINOCAPROIC ACID IN PLASTIC CONTAINER250MG/MLINJECTABLE / INJECTIONAPRS1987-03-09053a50430f4f…
2023-01-26 05:58 UTC2023-01A070010-001AMINOCAPROIC ACID IN PLASTIC CONTAINER250MG/MLINJECTABLE / INJECTIONAPRS1987-03-093bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A070010-001AMINOCAPROIC ACID IN PLASTIC CONTAINER250MG/MLINJECTABLE / INJECTIONAPRS1987-03-093a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A070010-001AMINOCAPROIC ACID IN PLASTIC CONTAINER250MG/MLINJECTABLE / INJECTIONAPRS1987-03-09f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A070010-001AMINOCAPROIC ACID IN PLASTIC CONTAINER250MG/MLINJECTABLE / INJECTIONAPRS1987-03-09e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A070010-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A070010-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070010-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A070010-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070010-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070010-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070010-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070010-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070010-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070010-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A070010-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070010-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070010-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070010-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A070010-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A070010-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A070010-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A070010-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A070010-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A070010-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A070010-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A070010-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A070010-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A070010-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A070010-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A070010-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A070010-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A070010-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A070010-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A070010-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A070010-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A070010-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A070010-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A070010-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A070010-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A070010-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A070010-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A070010-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A070010-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A070010-001AP1e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
Aminocaproic Acid
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMINOCAPROIC ACID250 mg/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
1718760Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4629d585-134b-a479-e063-6294a90a3432Available 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
71872-7359-1Aminocaproic Acid1 in 1 BAGINJECTION, SOLUTION11
71872-7359-1Aminocaproic Acid20 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION201

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 ACIDHospira, Inc.1c5bc1dd-e9ec-44c1-9281-67ad482315d92026-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070010
application number: ANDA070010
Aminocaproic AcidAMINOCAPROIC ACIDMedical Purchasing Solutions, LLC4629d585-134b-a479-e063-6294a90a34322025-12-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070010
application number: ANDA070010
ndc (product): 71872-7359
AMINOCAPROIC ACIDAMINOCAPROIC ACIDHenry Schein, Inc.5ff09f58-c225-4792-9f1e-9d2b7a4135212025-07-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070010
application number: ANDA070010

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1718760aminocaproic acid 5 GM in 20 ML InjectionPSN4629d585-134b-a479-e063-6294a90a34321
171876020 ML 6-aminocaproic acid 250 MG/ML InjectionSCD4629d585-134b-a479-e063-6294a90a34321
1718760aminocaproic acid 5 GM per 20 ML InjectionSY4629d585-134b-a479-e063-6294a90a34321

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71872-7359-1718727359011 VIAL, SINGLE-DOSE in 1 BAG (71872-7359-1) / 20 mL in 1 VIAL, SINGLE-DOSE2025-09-11NoNoCurrent