Aminocaproic Acid

Product NDC: 17478-768
11-digit product format: 174780768
Labeler code: 17478
Product ID: 17478-768_44814e91-37c0-4652-8c2b-96a35e23c45b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Aminocaproic Acid
Dosage form: TABLET
Route: ORAL
Labeler: Akorn Operating Company LLC
Application: NDA015197
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2019-03-12
Marketing end: 0000-00-00
Substance: AMINOCAPROIC ACID
Active strength: 500 mg/1
Pharmacologic classes: Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]
NDC exclude flag: No
Listing certified through: 2023-12-31
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	17478-768		D	Discontinued by firm		2026-08-17
excluded package	package	17478-768	17478-768-30	D	Discontinued by firm		2026-08-17

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	17478-768		D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	17478-768	17478-768-30	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N015197-001	AMICAR	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	RLD, Approved before 1982
N015197-002	AMICAR	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	RLD	2004-06-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N015197-001	AB
N015197-002	AB

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N015197-001	AMICAR	500MG	TABLET / ORAL	AB	RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N015197-002	AMICAR	1GM	TABLET / ORAL	AB	RLD	2004-06-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N015197-001	AMICAR	500MG	TABLET / ORAL	AB	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N015197-002	AMICAR	1GM	TABLET / ORAL	AB	RLD	2004-06-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N015197-001	AMICAR	500MG	TABLET / ORAL	AB	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N015197-002	AMICAR	1GM	TABLET / ORAL	AB	RLD	2004-06-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N015197-001	AMICAR	500MG	TABLET / ORAL	AB	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N015197-002	AMICAR	1GM	TABLET / ORAL	AB	RLD	2004-06-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N015197-001	AMICAR	500MG	TABLET / ORAL	AB	RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N015197-002	AMICAR	1GM	TABLET / ORAL	AB	RLD	2004-06-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N015197-001	AMICAR	500MG	TABLET / ORAL	AB	RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N015197-002	AMICAR	1GM	TABLET / ORAL	AB	RLD	2004-06-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N015197-001	AMICAR	500MG	TABLET / ORAL	AB	RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N015197-002	AMICAR	1GM	TABLET / ORAL	AB	RLD	2004-06-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N015197-001	AMICAR	500MG	TABLET / ORAL	AB	RLD, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N015197-002	AMICAR	1GM	TABLET / ORAL	AB	RLD	2004-06-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N015197-001	AMICAR	500MG	TABLET / ORAL		RLD, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N015197-002	AMICAR	1GM	TABLET / ORAL		RLD	2004-06-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N015197-001	AMICAR	500MG	TABLET / ORAL		RLD, Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N015197-002	AMICAR	1GM	TABLET / ORAL		RLD	2004-06-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N015197-001	AMICAR	500MG	TABLET / ORAL		RLD, Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N015197-002	AMICAR	1GM	TABLET / ORAL		RLD	2004-06-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N015197-001	AMICAR	500MG	TABLET / ORAL		RLD, Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N015197-002	AMICAR	1GM	TABLET / ORAL		RLD	2004-06-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N015197-001	AMICAR	500MG	TABLET / ORAL		RLD, Approved before 1982		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N015197-002	AMICAR	1GM	TABLET / ORAL		RLD	2004-06-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N015197-001	AMICAR	500MG	TABLET / ORAL		RLD, Approved before 1982		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N015197-002	AMICAR	1GM	TABLET / ORAL		RLD	2004-06-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N015197-001	AMICAR	500MG	TABLET / ORAL		RLD, Approved before 1982		`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N015197-002	AMICAR	1GM	TABLET / ORAL		RLD	2004-06-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N015197-001	AMICAR	500MG	TABLET / ORAL	AB	RLD, Approved before 1982		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N015197-002	AMICAR	1GM	TABLET / ORAL	AB	RLD	2004-06-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N015197-001	AMICAR	500MG	TABLET / ORAL	AB	RLD, Approved before 1982		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N015197-002	AMICAR	1GM	TABLET / ORAL	AB	RLD	2004-06-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N015197-001	AMICAR	500MG	TABLET / ORAL	AB	RLD, Approved before 1982		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N015197-002	AMICAR	1GM	TABLET / ORAL	AB	RLD	2004-06-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N015197-001	AMICAR	500MG	TABLET / ORAL	AB	RLD, Approved before 1982		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N015197-002	AMICAR	1GM	TABLET / ORAL	AB	RLD	2004-06-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N015197-001	AMICAR	500MG	TABLET / ORAL	AB	RLD, Approved before 1982		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N015197-002	AMICAR	1GM	TABLET / ORAL	AB	RLD	2004-06-24	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 70 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N015197-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N015197-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N015197-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N015197-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N015197-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N015197-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N015197-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N015197-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N015197-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N015197-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N015197-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N015197-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N015197-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N015197-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N015197-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N015197-002	AB	1	`2680178bc6a6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N015197-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N015197-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N015197-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N015197-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N015197-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N015197-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N015197-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N015197-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N015197-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N015197-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N015197-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N015197-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N015197-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N015197-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N015197-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N015197-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N015197-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N015197-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N015197-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N015197-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N015197-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N015197-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N015197-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N015197-002	AB	1	`b00525d2431f…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
83904ae6-37b6-4aa3-b6c9-663bc8d6ab8d	Product name	9	20250103
e89c33e6-9224-49b0-4d80-05239f586f24	Product name	1	20140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
17478-768-30	EA - Each	17478-768	d3557d0f-659f-4992-8e86-704cb617c2c8	1	2019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17478-768	AMINOCAPROIC ACID TABLET AMINOCAPROIC ACID SYRUP [AKORN OPERATING COMPANY LLC]	3	Legacy NDC	20220707_f90e9443-78d3-4709-b6be-ee9aacef2afb.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	Hikma Pharmaceuticals USA Inc.	7b8f0ddb-00fd-4c22-afae-afe636f95f3a	2024-01-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 015197 application number: NDA015197

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
17478-768-30	17478076830	30 TABLET in 1 BOTTLE (17478-768-30)	30 tablet	2019-03-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Aminocaproic Acid Tablets USP 500 mg, 1000 mg and Oral Solution 0.25 g/mL	Akorn Operating Company LLC \| Mikart, Inc.	2022-07-06	HUMAN PRESCRIPTION DRUG LABEL	3