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Active ingredient

Cyproheptadine

36 finished FDA listings contain Cyproheptadine as their only active ingredient.

FDA NDC Directory

Ingredient names as written by FDA
CYPROHEPTADINE, CYPROHEPTADINE HYDROCHLORIDE
Dosage forms
Solution, Syrup, Tablet
Routes
Oral
Manufacturers / labelers
22
Strengths listed
2 mg/5ml · 4 mg/1
Brand names in FDA listings
Cyproheptadine, Cyproheptadine Hydrochloride Solution

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 3013

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 088212CHARTWELL RX1983-05-261
ANDA 040537MOUNTAIN2003-09-304
ANDA 040668RISING2006-06-282
ANDA 205087INGENUS PHARMS LLC2015-09-232
ANDA 206553APPCO2016-11-295
ANDA 207555RISING2017-01-311
ANDA 208938ZYDUS PHARMS2017-05-193
ANDA 203191CHARTWELL MOLECULAR2017-07-131
ANDA 209172STRIDES PHARMA INTL2018-04-112
ANDA 209108ST JOHN PHARM2018-10-162
ANDA 206676REGCON HOLDINGS2019-04-122
ANDA 212423QUAGEN2019-05-224
ANDA 212491QUAGEN2021-02-246
ANDA 205431TRIS PHARMA INC2021-12-211

Official labeling on DailyMed

Showing the 12 most recent of 35 labels.

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