AMICAR

Product NDC: 49411-050
11-digit product format: 494110050
Labeler code: 49411
Product ID: 49411-050_bcb6223c-cffb-4b9f-9688-9e670d1bb21b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Aminocaproic Acid
Dosage form: TABLET
Route: ORAL
Labeler: Akorn Operating Company LLC
Application: NDA015197
Marketing category: NDA
Marketing start: 2015-06-01
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	49411-050		D	Discontinued by firm		2026-08-17
excluded package	package	49411-050	49411-050-30	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	49411-050		D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49411-050	49411-050-30	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
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49411-050-30	EA - Each	49411-050	48a28c70-c9ba-4f0b-b199-8cf8c5309c91	1	2015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMINOCAPROIC ACID	ACTIVE INGREDIENT	U6F3787206	AMICAR (AMINOCAPROIC ACID) SOLUTION AMICAR (AMINOCAPROIC ACID) TABLET [CLOVER PHARMACEUTICALS CORP.]	4
AMINOCAPROIC ACID	ACTIVE MOIETY	U6F3787206	AMICAR (AMINOCAPROIC ACID) SOLUTION AMICAR (AMINOCAPROIC ACID) TABLET [CLOVER PHARMACEUTICALS CORP.]	4
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	AMICAR (AMINOCAPROIC ACID) SOLUTION AMICAR (AMINOCAPROIC ACID) TABLET [CLOVER PHARMACEUTICALS CORP.]	4
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	AMICAR (AMINOCAPROIC ACID) SOLUTION AMICAR (AMINOCAPROIC ACID) TABLET [CLOVER PHARMACEUTICALS CORP.]	4
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	AMICAR (AMINOCAPROIC ACID) SOLUTION AMICAR (AMINOCAPROIC ACID) TABLET [CLOVER PHARMACEUTICALS CORP.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMICAR (AMINOCAPROIC ACID) SOLUTION AMICAR (AMINOCAPROIC ACID) TABLET [CLOVER PHARMACEUTICALS CORP.]	4
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	AMICAR (AMINOCAPROIC ACID) SOLUTION AMICAR (AMINOCAPROIC ACID) TABLET [CLOVER PHARMACEUTICALS CORP.]	4
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	AMICAR (AMINOCAPROIC ACID) SOLUTION AMICAR (AMINOCAPROIC ACID) TABLET [CLOVER PHARMACEUTICALS CORP.]	4
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	AMICAR (AMINOCAPROIC ACID) SOLUTION AMICAR (AMINOCAPROIC ACID) TABLET [CLOVER PHARMACEUTICALS CORP.]	4
RASPBERRY	INACTIVE INGREDIENT	4N14V5R27W	AMICAR (AMINOCAPROIC ACID) SOLUTION AMICAR (AMINOCAPROIC ACID) TABLET [CLOVER PHARMACEUTICALS CORP.]	4
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	AMICAR (AMINOCAPROIC ACID) SOLUTION AMICAR (AMINOCAPROIC ACID) TABLET [CLOVER PHARMACEUTICALS CORP.]	4
SORBITOL	INACTIVE INGREDIENT	506T60A25R	AMICAR (AMINOCAPROIC ACID) SOLUTION AMICAR (AMINOCAPROIC ACID) TABLET [CLOVER PHARMACEUTICALS CORP.]	4
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	AMICAR (AMINOCAPROIC ACID) SOLUTION AMICAR (AMINOCAPROIC ACID) TABLET [CLOVER PHARMACEUTICALS CORP.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49411-050	AMICAR (AMINOCAPROIC ACID) SOLUTION AMICAR (AMINOCAPROIC ACID) TABLET [AKORN OPERATING COMPANY LLC]	8	Legacy NDC	20220701_2238c70f-b0b5-4755-896b-45b28777b217.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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
211465	Amicar 500 MG Oral Tablet	PSN	05b08095-2acc-47ef-a426-b68c7d95de95	5
197351	aminocaproic acid 500 MG Oral Tablet	PSN	05b08095-2acc-47ef-a426-b68c7d95de95	5
211465	6-aminocaproic acid 500 MG Oral Tablet [Amicar]	SBD	05b08095-2acc-47ef-a426-b68c7d95de95	5
197351	6-aminocaproic acid 500 MG Oral Tablet	SCD	05b08095-2acc-47ef-a426-b68c7d95de95	5
211465	Amicar 500 MG Oral Tablet	SY	05b08095-2acc-47ef-a426-b68c7d95de95	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49411-050-30	49411005030	30 TABLET in 1 BOTTLE, PLASTIC (49411-050-30)	30 tablet	2015-06-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
AMICAR ® (aminocaproic acid) Oral Solution and Tablets	Akorn Operating Company LLC \| Mikart Inc.	2022-06-28	HUMAN PRESCRIPTION DRUG LABEL	8
AMICAR	Carilion Materials Management	2018-08-06	HUMAN PRESCRIPTION DRUG LABEL	5