Aminocaproic acid

Product NDC: 71151-026
11-digit product format: 711510026
Labeler code: 71151
Product ID: 71151-026_fd55cb53-d831-4da7-b85e-5beb701948c7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Aminocaproic acid
Dosage form: SOLUTION
Route: ORAL
Labeler: airis PHARMA Private Limited
Application: ANDA213825
Marketing category: ANDA
Marketing start: 2021-04-23
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: 2022-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	71151-026		I	Inactivated by FDA		2026-08-10
excluded package	package	71151-026	71151-026-01	I	Inactivated by FDA		2026-08-10

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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71151-026-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71151-026-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71151-026-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71151-026-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71151-026-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71151-026-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71151-026-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71151-026-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	71151-026-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	71151-026-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	71151-026-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	71151-026-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	71151-026-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	71151-026-01	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	71151-026-01	`1332a3947898…`	`d4bfe170f9cd…`

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
A213825-001	AMINOCAPROIC ACID	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION / ORAL	AA		2021-04-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213825-001	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	A213825-001	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION / ORAL	AA	2021-04-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213825-001	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION / ORAL	AA	2021-04-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213825-001	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION / ORAL	AA	2021-04-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213825-001	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION / ORAL	AA	2021-04-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213825-001	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION / ORAL	AA	2021-04-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213825-001	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION / ORAL	AA	2021-04-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213825-001	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION / ORAL	AA	2021-04-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213825-001	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION / ORAL	AA	2021-04-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213825-001	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION / ORAL	AA	2021-04-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213825-001	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION / ORAL	AA	2021-04-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213825-001	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION / ORAL	AA	2021-04-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213825-001	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION / ORAL	AA	2021-04-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213825-001	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION / ORAL	AA	2021-04-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213825-001	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION / ORAL	AA	2021-04-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213825-001	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION / ORAL	AA	2021-04-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213825-001	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION / ORAL	AA	2021-04-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213825-001	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION / ORAL	AA	2021-04-08	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213825-001	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION / ORAL	AA	2021-04-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213825-001	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION / ORAL	AA	2021-04-08	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213825-001	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION / ORAL	AA	2021-04-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213825-001	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION / ORAL	AA	2021-04-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213825-001	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION / ORAL	AA	2021-04-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213825-001	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION / ORAL	AA	2021-04-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213825-001	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION / ORAL	AA	2021-04-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213825-001	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION / ORAL	AA	2021-04-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213825-001	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION / ORAL	AA	2021-04-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213825-001	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION / ORAL	AA	2021-04-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213825-001	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION / ORAL	AA	2021-04-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213825-001	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION / ORAL	AA	2021-04-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213825-001	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION / ORAL	AA	2021-04-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213825-001	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION / ORAL	AA	2021-04-08	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213825-001	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION / ORAL	AA	2021-04-08	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213825-001	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION / ORAL	AA	2021-04-08	`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	A213825-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213825-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213825-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213825-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213825-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213825-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213825-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213825-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213825-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213825-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213825-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213825-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213825-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213825-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213825-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213825-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213825-001	AA	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213825-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213825-001	AA	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213825-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213825-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213825-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213825-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213825-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213825-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213825-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213825-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213825-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213825-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213825-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213825-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213825-001	AA	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213825-001	AA	1	`a50c72e98297…`

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
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
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
71151-026-01	2023-01-30	C162847	48780-1	f386c64a-3168-0266-e053-dadaa90a7c1a	Aminocaproic Acid Oral Solution, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71151-026-01	Aminocaproic acid	236.5 mL in 1 BOTTLE, PLASTIC	SOLUTION	236.5		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71151-026	AMINOCAPROIC ACID SOLUTION [AIRIS PHARMA PRIVATE LIMITED]	3	Legacy NDC, 1 package rows	20210603_1de5190f-8a2d-41f0-afa4-fcd2062b286a.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aminocaproic acid	AMINOCAPROIC ACID	BPI LABS LLC	cfa601c4-b649-417e-a301-b246f080f1eb	2026-01-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213825 application number: ANDA213825

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	1de5190f-8a2d-41f0-afa4-fcd2062b286a	3
582299	6-aminocaproic acid 250 MG/ML Oral Solution	SCD	1de5190f-8a2d-41f0-afa4-fcd2062b286a	3
582299	6-aminocaproic acid 0.25 GM per ML Oral Syrup	SY	1de5190f-8a2d-41f0-afa4-fcd2062b286a	3
582299	6-aminocaproic acid 1.25 GM per 5 ML Oral Syrup	SY	1de5190f-8a2d-41f0-afa4-fcd2062b286a	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71151-026-01	71151002601	236.5 mL in 1 BOTTLE, PLASTIC (71151-026-01)	236.5 ml	2021-04-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Aminocaproic Acid Oral Solution, USP Rx only	airis PHARMA Private Limited \| CoreRx Inc.	2021-04-22	HUMAN PRESCRIPTION DRUG LABEL	3