Aminocaproic Acid

Product NDC: 0054-1110
11-digit product format: 000541110
Labeler code: 0054
Product ID: 0054-1110_7b8f0ddb-00fd-4c22-afae-afe636f95f3a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Aminocaproic Acid
Dosage form: TABLET
Route: ORAL
Labeler: Hikma Pharmaceuticals USA Inc.
Application: NDA015197
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2019-03-12
Substance: AMINOCAPROIC ACID
Active strength: 1000 mg/1
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 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…`

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	1000 mg/1

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
476271	Internal RxNorm lookup
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
7b8f0ddb-00fd-4c22-afae-afe636f95f3a	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
e89c33e6-9224-49b0-4d80-05239f586f24	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0054-1110-13	Aminocaproic Acid	30 in 1 BOTTLE	TABLET	30		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0054-1110-13	EA - Each	0054-1110	4117395d-efdf-43da-8691-d22d74ec5d8b	1	2024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0054-1110	AMINOCAPROIC ACID TABLET AMINOCAPROIC ACID SYRUP [HIKMA PHARMACEUTICALS USA INC.]	1	Current NDC, 1 package rows	20241114_7b8f0ddb-00fd-4c22-afae-afe636f95f3a.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 ndc (product): 0054-1110

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	7b8f0ddb-00fd-4c22-afae-afe636f95f3a	1
476271	aminocaproic acid 1000 MG Oral Tablet	PSN	7b8f0ddb-00fd-4c22-afae-afe636f95f3a	1
476271	6-aminocaproic acid 1000 MG Oral Tablet	SCD	7b8f0ddb-00fd-4c22-afae-afe636f95f3a	1
582299	6-aminocaproic acid 250 MG/ML Oral Solution	SCD	7b8f0ddb-00fd-4c22-afae-afe636f95f3a	1
582299	6-aminocaproic acid 0.25 GM per ML Oral Syrup	SY	7b8f0ddb-00fd-4c22-afae-afe636f95f3a	1
582299	6-aminocaproic acid 1.25 GM per 5 ML Oral Syrup	SY	7b8f0ddb-00fd-4c22-afae-afe636f95f3a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0054-1110-13	00054111013	30 TABLET in 1 BOTTLE (0054-1110-13)	30 tablet	2024-11-12	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Aminocaproic Acid Tablets USP, 500 mg and 1,000 mg Aminocaproic Acid Oral Solution USP, 0.25 g/mL	Hikma Pharmaceuticals USA Inc.	2024-01-08	HUMAN PRESCRIPTION DRUG LABEL	1