AMINOCAPROIC ACID

Product NDC: 80005-130
Requested package NDC: 80005-130-22
11-digit product format: 800050130
Labeler code: 80005
Product ID: 80005-130_acb7cc2c-2aea-4c13-96b5-e2d1840ea1d2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: AMINOCAPROIC ACID
Dosage form: SOLUTION
Route: ORAL
Labeler: Carnegie Pharmaceuticals, LLC
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: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A214140-001	AMINOCAPROIC ACID	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION / ORAL	AA		2021-01-26

Therapeutic equivalence codes#

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

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

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A214140-001	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION / ORAL	AA	2021-01-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214140-001	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION / ORAL	AA	2021-01-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214140-001	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION / ORAL	AA	2021-01-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214140-001	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION / ORAL	AA	2021-01-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214140-001	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION / ORAL	AA	2021-01-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214140-001	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION / ORAL	AA	2021-01-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214140-001	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION / ORAL	AA	2021-01-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214140-001	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION / ORAL	AA	2021-01-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214140-001	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION / ORAL	AA	2021-01-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214140-001	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION / ORAL	AA	2021-01-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214140-001	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION / ORAL	AA	2021-01-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214140-001	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION / ORAL	AA	2021-01-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214140-001	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION / ORAL	AA	2021-01-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214140-001	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION / ORAL	AA	2021-01-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214140-001	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION / ORAL	AA	2021-01-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214140-001	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION / ORAL	AA	2021-01-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214140-001	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION / ORAL	AA	2021-01-26	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214140-001	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION / ORAL	AA	2021-01-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214140-001	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION / ORAL	AA	2021-01-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A214140-001	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION / ORAL	AA	2021-01-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A214140-001	AMINOCAPROIC ACID	1.25GM/5ML	SYRUP / ORAL	AA	2021-01-26	`5aa47cf7b7d7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214140-001	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION / ORAL	AA	2021-01-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214140-001	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION / ORAL	AA	2021-01-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214140-001	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION / ORAL	AA	2021-01-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214140-001	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION / ORAL	AA	2021-01-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214140-001	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION / ORAL	AA	2021-01-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214140-001	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION / ORAL	AA	2021-01-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214140-001	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION / ORAL	AA	2021-01-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214140-001	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION / ORAL	AA	2021-01-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214140-001	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION / ORAL	AA	2021-01-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214140-001	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION / ORAL	AA	2021-01-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214140-001	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION / ORAL	AA	2021-01-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214140-001	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION / ORAL	AA	2021-01-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214140-001	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION / ORAL	AA	2021-01-26	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214140-001	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION / ORAL	AA	2021-01-26	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A214140-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214140-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214140-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214140-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214140-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214140-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214140-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214140-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214140-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214140-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214140-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214140-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214140-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214140-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214140-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214140-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214140-001	AA	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214140-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214140-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A214140-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A214140-001	AA	1	`5aa47cf7b7d7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214140-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214140-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214140-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214140-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214140-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214140-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214140-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214140-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214140-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214140-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214140-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214140-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214140-001	AA	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214140-001	AA	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: AMINOCAPROIC ACID
Listing expiration: 2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
U6F3787206	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
582299	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
0d6560a3-c67e-428e-b9b8-fab538856b41	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
83904ae6-37b6-4aa3-b6c9-663bc8d6ab8d	Product name	9	20250103
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
e89c33e6-9224-49b0-4d80-05239f586f24	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
80005-130-22	2024-03-04	C162847	48780-1	1030e365-1c4f-111a-e063-dadaa90a10e2	Aminocaproic Acid Oral Solution, USP Rx only
80005-130-22	2024-01-30	C162847	48780-1	1030e365-1c4f-111a-e063-dadaa90a10e2	Aminocaproic Acid Oral Solution, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
80005-130-22	AMINOCAPROIC ACID	236.5 mL in 1 BOTTLE	SOLUTION	236.5		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80005-130-22	ML - Milliliter	80005-130	1c444705-aa7a-4ea3-8f12-2e0304cc3330	1	2025-10-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80005-130	AMINOCAPROIC ACID SOLUTION [CARNEGIE PHARMACEUTICALS, LLC]	3	Current NDC, Legacy NDC, 1 package rows	20240307_0d6560a3-c67e-428e-b9b8-fab538856b41.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AMINOCAPROIC ACID	AMINOCAPROIC ACID	Bryant Ranch Prepack	c2144bf8-1a26-4958-ba10-5358bd69cd23	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214140 application number: ANDA214140
AMINOCAPROIC ACID	AMINOCAPROIC ACID	Carnegie Pharmaceuticals, LLC	0d6560a3-c67e-428e-b9b8-fab538856b41	2024-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214140 application number: ANDA214140 ndc (package): 80005-130-22 ndc (product): 80005-130 ndc11 (package): 80005013022
AMINOCAPROIC ACID	AMINOCAPROIC ACID	Biocon Pharma Inc.	c3cadb3a-4f63-06ee-0dd2-6828dbc1fffa	2021-01-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214140 application number: ANDA214140

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
U6F3787206	AMINOCAPROIC ACID	60-32-2	AMINOCAPROIC ACID

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
582299	aminocaproic acid 0.25 GM/mL Oral Solution	PSN	c2144bf8-1a26-4958-ba10-5358bd69cd23	100
582299	6-aminocaproic acid 250 MG/ML Oral Solution	SCD	c2144bf8-1a26-4958-ba10-5358bd69cd23	100
582299	6-aminocaproic acid 0.25 GM per ML Oral Syrup	SY	c2144bf8-1a26-4958-ba10-5358bd69cd23	100
582299	6-aminocaproic acid 1.25 GM per 5 ML Oral Syrup	SY	c2144bf8-1a26-4958-ba10-5358bd69cd23	100
582299	aminocaproic acid 0.25 GM/mL Oral Solution	PSN	0d6560a3-c67e-428e-b9b8-fab538856b41	3
582299	6-aminocaproic acid 250 MG/ML Oral Solution	SCD	0d6560a3-c67e-428e-b9b8-fab538856b41	3
582299	6-aminocaproic acid 0.25 GM per ML Oral Syrup	SY	0d6560a3-c67e-428e-b9b8-fab538856b41	3
582299	6-aminocaproic acid 1.25 GM per 5 ML Oral Syrup	SY	0d6560a3-c67e-428e-b9b8-fab538856b41	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
80005-130-22	80005013022	236.5 mL in 1 BOTTLE (80005-130-22)	236.5 ml	2021-03-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Aminocaproic Acid Oral Solution, USP Rx only	Bryant Ranch Prepack	2026-05-19	HUMAN PRESCRIPTION DRUG LABEL	100
Aminocaproic Acid Oral Solution, USP Rx only	Carnegie Pharmaceuticals, LLC	2024-03-05	HUMAN PRESCRIPTION DRUG LABEL	3