AMINOCAPROIC ACID

Product NDC: 69315-232
11-digit product format: 693150232
Labeler code: 69315
Product ID: 69315-232_9c07c233-2357-4862-8342-8b8a2c3da9f8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: AMINOCAPROIC ACID
Dosage form: TABLET
Route: ORAL
Labeler: Leading Pharma, LLC
Application: ANDA213928
Marketing category: ANDA
Marketing start: 2021-03-15
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: 2022-12-31
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	69315-232		D	Discontinued by firm		2026-08-11
excluded package	package	69315-232	69315-232-03	D	Discontinued by firm		2026-08-11

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	69315-232-03	`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	69315-232-03	`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	69315-232-03	`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	69315-232-03	`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	69315-232-03	`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	69315-232-03	`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	69315-232-03	`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	69315-232-03	`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	69315-232-03	`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	69315-232-03	`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	69315-232-03	`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	69315-232-03	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A213928-001	AMINOCAPROIC ACID	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB		2021-02-12
A213928-002	AMINOCAPROIC ACID	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB		2021-02-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A213928-001	AB
A213928-002	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 2 · 68 observed 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
2026-02-19 14:30 UTC	2026-02	A213928-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2021-02-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213928-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	2021-02-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213928-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2021-02-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213928-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	2021-02-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213928-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2021-02-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213928-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	2021-02-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213928-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2021-02-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213928-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	2021-02-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213928-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2021-02-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213928-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	2021-02-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213928-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2021-02-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213928-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	2021-02-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213928-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2021-02-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213928-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	2021-02-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213928-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2021-02-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213928-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	2021-02-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213928-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2021-02-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213928-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	2021-02-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213928-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2021-02-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213928-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	2021-02-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213928-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2021-02-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213928-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	2021-02-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213928-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2021-02-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213928-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	2021-02-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213928-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2021-02-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213928-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	2021-02-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213928-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2021-02-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213928-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	2021-02-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213928-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2021-02-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213928-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	2021-02-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213928-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2021-02-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213928-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	2021-02-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213928-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2021-02-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213928-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	2021-02-12	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213928-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2021-02-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213928-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	2021-02-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213928-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2021-02-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213928-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	2021-02-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213928-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2021-02-12	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213928-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	2021-02-12	`87673890dc5c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 68 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A213928-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213928-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213928-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213928-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213928-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213928-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213928-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213928-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213928-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213928-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213928-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213928-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213928-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213928-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213928-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213928-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213928-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213928-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213928-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213928-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213928-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213928-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213928-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213928-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213928-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213928-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213928-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213928-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213928-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213928-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213928-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213928-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213928-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213928-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213928-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213928-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213928-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213928-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213928-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213928-002	AB	1	`87673890dc5c…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69315-232-03	2023-04-20	C162847	48780-1	f386c649-b698-0266-e053-dadaa90a7c1a	Aminocaproic Acid Tablets, USP Rx only
69315-232-03	2023-01-30	C162847	48780-1	f386c649-b698-0266-e053-dadaa90a7c1a	Aminocaproic Acid Tablets, USP Rx only

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69315-232-03	EA - Each	69315-232	8e424e59-ea29-4f98-938e-2dc939307b6d	1	2021-08-05

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AMINOCAPROIC ACID	AMINOCAPROIC ACID	PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS	7d08ad63-71f5-4286-9622-84295668a293	2025-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213928 application number: ANDA213928
AMINOCAPROIC ACID	AMINOCAPROIC ACID	Carnegie Pharmaceuticals, LLC	871ec401-30f8-4154-a16e-b82dc1e04b49	2023-04-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213928 application number: ANDA213928
AMINOCAPROIC ACID	AMINOCAPROIC ACID	Biocon Pharma Inc.	9205fb6b-24a0-1138-fd7b-cc33d0df5d6f	2021-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213928 application number: ANDA213928

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
69315-232-03	69315023203	30 TABLET in 1 BOTTLE (69315-232-03)	30 tablet	2021-03-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Aminocaproic Acid Tablets, USP Rx only	Leading Pharma, LLC \| Carnegie Pharmaceuticals, LLC	2021-08-12	HUMAN PRESCRIPTION DRUG LABEL	4