Aminocaproic acid

Product NDC: 0904-7165
11-digit product format: 009047165
Labeler code: 0904
Product ID: 0904-7165_78c15c64-2046-4fa2-a82e-a27879403756
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Aminocaproic acid
Dosage form: TABLET
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA212492
Marketing category: ANDA
Marketing start: 2019-11-30
Substance: AMINOCAPROIC ACID
Active strength: 500 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A212492-001	AMINOCAPROIC ACID	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB		2019-11-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212492-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A212492-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2019-11-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212492-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2019-11-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212492-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2019-11-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212492-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2019-11-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212492-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2019-11-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212492-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2019-11-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212492-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2019-11-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212492-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2019-11-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212492-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2019-11-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212492-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2019-11-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212492-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2019-11-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212492-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2019-11-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212492-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2019-11-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212492-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2019-11-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212492-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2019-11-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212492-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2019-11-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212492-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2019-11-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212492-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2019-11-26	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212492-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2019-11-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212492-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2019-11-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212492-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2019-11-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212492-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2019-11-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212492-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2019-11-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212492-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2019-11-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A212492-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2019-11-26	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212492-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2019-11-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212492-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2019-11-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212492-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2019-11-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212492-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2019-11-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212492-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2019-11-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212492-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2019-11-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212492-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2019-11-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212492-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2019-11-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212492-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2019-11-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212492-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2019-11-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212492-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2019-11-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212492-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2019-11-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212492-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2019-11-26	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212492-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2019-11-26	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A212492-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212492-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212492-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212492-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212492-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212492-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212492-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212492-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212492-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212492-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212492-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212492-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212492-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212492-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212492-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212492-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212492-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212492-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212492-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212492-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212492-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212492-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212492-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212492-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A212492-001	AB	1	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212492-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212492-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212492-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212492-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212492-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212492-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212492-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212492-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212492-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212492-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212492-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212492-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212492-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212492-001	AB	1	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2020-12-22 03:56 UTC	2020-12	A212492-001	CGT	2020-05-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212492-001	CGT	2020-05-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A212492-001	CGT	2020-05-30	`3f01610625f2…`

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	500 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197351	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
2612ee97-1723-40f2-99e6-3a736f63200f	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
0904-7165-07	Aminocaproic acid	30 in 1 CARTON	TABLET	30		3
0904-7165-07	Aminocaproic acid	1 in 1 BLISTER PACK	TABLET	1		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-7165-07	EA - Each	0904-7165	e3fc1df0-1a61-433f-94d1-c68b5fcff4aa	1	2022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-7165	AMINOCAPROIC ACID TABLET [MAJOR PHARMACEUTICALS]	3	Current NDC, Legacy NDC, 2 package rows	20250402_2612ee97-1723-40f2-99e6-3a736f63200f.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aminocaproic acid	AMINOCAPROIC ACID	Amneal Pharmaceuticals LLC	4a22e559-2dac-42d7-af8d-eb0ebbc2f76d	2026-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212492 application number: ANDA212492
Aminocaproic acid	AMINOCAPROIC ACID	Major Pharmaceuticals	2612ee97-1723-40f2-99e6-3a736f63200f	2025-03-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212492 application number: ANDA212492 ndc (product): 0904-7165

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
197351	aminocaproic acid 500 MG Oral Tablet	PSN	2612ee97-1723-40f2-99e6-3a736f63200f	3
197351	6-aminocaproic acid 500 MG Oral Tablet	SCD	2612ee97-1723-40f2-99e6-3a736f63200f	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-7165-07	00904716507	30 BLISTER PACK in 1 CARTON (0904-7165-07) / 1 TABLET in 1 BLISTER PACK	30 blister pack	2019-11-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Aminocaproic Acid Tablets, USP (500 mg) Rx only	Major Pharmaceuticals	2025-03-28	HUMAN PRESCRIPTION DRUG LABEL	3