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Active ingredient

Amitriptyline

209 finished FDA listings contain Amitriptyline as their only active ingredient; 7 combination products also contain it.

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FDA NDC Directory

Ingredient names as written by FDA
AMITRIPTYLINE HYDROCHLORIDE
Dosage forms
Tablet, Tablet, Coated, Tablet, Film Coated
Routes
Oral
Manufacturers / labelers
36
Strengths listed
10 mg/1 · 100 mg/1 · 150 mg/1 · 25 mg/1 · 50 mg/1 · 75 mg/1

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 704

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
ANDA 085968SANDOZ1977-11-299
ANDA 086009AUROBINDO PHARMA USA1978-04-105
ANDA 089399SUN PHARM INDS INC1987-07-1420
ANDA 202446ACCORD HLTHCARE2014-06-0411
ANDA 210086ZYDUS PHARMS2017-10-0627
ANDA 212654AIPING PHARM INC2020-04-0726
ANDA 213999MANKIND PHARMA2021-02-1912
ANDA 214548UNICHEM2021-05-1957
ANDA 216243BRECKENRIDGE2022-06-066
ANDA 215376RUBICON RESEARCH2023-05-016
ANDA 217411RISING2023-05-1930

Official labeling on DailyMed

Showing the 12 most recent of 120 labels.

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