Aminocaproic acid

Product NDC: 60219-1637
Requested package NDC: 60219-1637-3
11-digit product format: 602191637
Labeler code: 60219
Product ID: 60219-1637_c69d729f-a296-42d7-a23e-517383f47d29
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Aminocaproic acid
Dosage form: TABLET
Route: ORAL
Labeler: Amneal Pharmaceuticals NY LLC
Application: ANDA212492
Marketing category: ANDA
Marketing start: 2019-11-30
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: 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	60219-1637	60219-1637-3	I	Inactivated by FDA		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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
60219-1637-3	2023-01-30	C162847	48780-1	f386c64a-3c89-0266-e053-dadaa90a7c1a	Aminocaproic Acid Tablets, USP (500 mg) Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
60219-1637-3	Aminocaproic acid	30 in 1 BOTTLE, PLASTIC	TABLET	30		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60219-1637-3	EA - Each	60219-1637	a82c141a-4485-4eb8-8950-740962f1158b	1	2020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60219-1637	AMINOCAPROIC ACID TABLET [AMNEAL PHARMACEUTICALS NY LLC]	5	Legacy NDC, 1 package rows	20200102_bc0267a5-15c9-4323-8cb9-44517bf87152.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

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	bc0267a5-15c9-4323-8cb9-44517bf87152	5
197351	6-aminocaproic acid 500 MG Oral Tablet	SCD	bc0267a5-15c9-4323-8cb9-44517bf87152	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60219-1637-3	60219163703	30 TABLET in 1 BOTTLE, PLASTIC (60219-1637-3)	30 tablet	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	Amneal Pharmaceuticals NY LLC \| Amneal Pharmaceuticals of New York, LLC \| Amneal Pharmaceuticals Private Limited Oral Solid Dosage Unit	2019-12-23	HUMAN PRESCRIPTION DRUG LABEL	5