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Active ingredient

6-Aminocaproic Acid

34 finished FDA listings contain 6-Aminocaproic Acid as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
AMINOCAPROIC ACID
Dosage forms
Injection, Solution, Solution, Syrup, Tablet
Routes
Intravenous, Oral
Manufacturers / labelers
22
Strengths listed
.25 g/ml · 1000 mg/1 · 250 mg/ml · 500 mg/1

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 99

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 015197HIKMA1964-06-031
NDA 015230HIKMA1964-06-041
ANDA 070010HOSPIRA1987-03-093
ANDA 071192LUITPOLD1987-12-014
ANDA 209060SUNNY2018-11-273
ANDA 212780AMNEAL2019-08-231
ANDA 212492AMNEAL2019-11-262
ANDA 212494TP ANDA HOLDINGS2020-08-111
ANDA 212938MSN2020-11-062
ANDA 214140CARNEGIE2021-01-263
ANDA 213928PHARMOBEDIENT2021-02-126
ANDA 213825AJENAT PHARMS2021-04-081
ANDA 215510REGCON HOLDINGS2022-03-231
ANDA 216804AUROBINDO PHARMA2022-09-261
ANDA 216464ANNORA PHARMA2022-11-041
ANDA 213213SUNNY2023-12-271
ANDA 215100MSN2024-09-261
ANDA 213216APOZEAL PHARMS2025-05-191

Official labeling on DailyMed

Showing the 12 most recent of 27 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.