Aminocaproic Acid

Product NDC: 61748-046
11-digit product format: 617480046
Labeler code: 61748
Product ID: 61748-046_e5ad3047-3a57-4f63-a99e-fc5ad4b5da63
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Aminocaproic Acid
Dosage form: TABLET
Route: ORAL
Labeler: Versapharm Incorporated
Application: NDA015197
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2012-06-01
Marketing end: 0000-00-00
Substance: AMINOCAPROIC ACID
Active strength: 1000 mg/1
Pharmacologic classes: Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE]
NDC exclude flag: No
Listing certified through: 2021-12-31
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	61748-046		D	Discontinued by firm		2026-08-17
excluded package	package	61748-046	61748-046-01	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 · 24 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	61748-046-01	`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	61748-046-01	`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	61748-046-01	`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	61748-046-01	`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	61748-046-01	`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	61748-046-01	`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	61748-046-01	`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	61748-046-01	`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	61748-046-01	`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	61748-046-01	`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	61748-046-01	`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	61748-046-01	`557ba5c1ecfa…`	`9c80585c8c6e…`

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61748-046-01	EA - Each	61748-046	03749aef-5336-4730-9934-64de780d1784	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMINOCAPROIC ACID	ACTIVE INGREDIENT	U6F3787206	AMINOCAPROIC ACID TABLET AMINOCAPROIC ACID SYRUP [VERSAPHARM INCORPORATED]	6
AMINOCAPROIC ACID	ACTIVE MOIETY	U6F3787206	AMINOCAPROIC ACID TABLET AMINOCAPROIC ACID SYRUP [VERSAPHARM INCORPORATED]	6
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	AMINOCAPROIC ACID TABLET AMINOCAPROIC ACID SYRUP [VERSAPHARM INCORPORATED]	6
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	AMINOCAPROIC ACID TABLET AMINOCAPROIC ACID SYRUP [VERSAPHARM INCORPORATED]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMINOCAPROIC ACID TABLET AMINOCAPROIC ACID SYRUP [VERSAPHARM INCORPORATED]	6
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	AMINOCAPROIC ACID TABLET AMINOCAPROIC ACID SYRUP [VERSAPHARM INCORPORATED]	6
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	AMINOCAPROIC ACID TABLET AMINOCAPROIC ACID SYRUP [VERSAPHARM INCORPORATED]	6
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	AMINOCAPROIC ACID TABLET AMINOCAPROIC ACID SYRUP [VERSAPHARM INCORPORATED]	6
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	AMINOCAPROIC ACID TABLET AMINOCAPROIC ACID SYRUP [VERSAPHARM INCORPORATED]	6
RASPBERRY	INACTIVE INGREDIENT	4N14V5R27W	AMINOCAPROIC ACID TABLET AMINOCAPROIC ACID SYRUP [VERSAPHARM INCORPORATED]	6
SACCHARIN SODIUM ANHYDROUS	INACTIVE INGREDIENT	I4807BK602	AMINOCAPROIC ACID TABLET AMINOCAPROIC ACID SYRUP [VERSAPHARM INCORPORATED]	6
SORBITOL	INACTIVE INGREDIENT	506T60A25R	AMINOCAPROIC ACID TABLET AMINOCAPROIC ACID SYRUP [VERSAPHARM INCORPORATED]	6
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	AMINOCAPROIC ACID TABLET AMINOCAPROIC ACID SYRUP [VERSAPHARM INCORPORATED]	6
WATER	INACTIVE INGREDIENT	059QF0KO0R	AMINOCAPROIC ACID TABLET AMINOCAPROIC ACID SYRUP [VERSAPHARM INCORPORATED]	6

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
61748-046-01	61748004601	100 TABLET in 1 BOTTLE (61748-046-01)	100 tablet	2012-06-01	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	Versapharm Incorporated \| Akorn Operating Company LLC \| Mikart, Inc.	2020-10-08	HUMAN PRESCRIPTION DRUG LABEL	8