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.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| ANDA 088212 | CHARTWELL RX | 1983-05-26 | 1 |
| ANDA 040537 | MOUNTAIN | 2003-09-30 | 4 |
| ANDA 040668 | RISING | 2006-06-28 | 2 |
| ANDA 205087 | INGENUS PHARMS LLC | 2015-09-23 | 2 |
| ANDA 206553 | APPCO | 2016-11-29 | 5 |
| ANDA 207555 | RISING | 2017-01-31 | 1 |
| ANDA 208938 | ZYDUS PHARMS | 2017-05-19 | 3 |
| ANDA 203191 | CHARTWELL MOLECULAR | 2017-07-13 | 1 |
| ANDA 209172 | STRIDES PHARMA INTL | 2018-04-11 | 2 |
| ANDA 209108 | ST JOHN PHARM | 2018-10-16 | 2 |
| ANDA 206676 | REGCON HOLDINGS | 2019-04-12 | 2 |
| ANDA 212423 | QUAGEN | 2019-05-22 | 4 |
| ANDA 212491 | QUAGEN | 2021-02-24 | 6 |
| ANDA 205431 | TRIS PHARMA INC | 2021-12-21 | 1 |
Official labeling on DailyMed
- CYPROHEPTADINE HYDROCHLORIDE TABLET [TRUPHARMA, LLC] · version 6 · 2026-08-21
- CYPROHEPTADINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] · version 7 · 2026-08-19
- CYPROHEPTADINE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORP.] · version 2 · 2026-08-10
- CYPROHEPTADINE HYDROCHLORIDE TABLET [TRUPHARMA, LLC] · version 1 · 2026-07-15
- CYPROHEPTADINE HYDROCHLORIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] · version 10 · 2026-07-06
- CYPROHEPTADINE HYDROCHLORIDE TABLET [REMEDYREPACK INC.] · version 1 · 2026-06-03
- CYPROHEPTADINE HYDROCHLORIDE TABLET [STRIDES PHARMA SCIENCE LIMITED] · version 3 · 2026-06-03
- CYPROHEPTADINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICAL CORP.] · version 1 · 2026-05-06
- CYPROHEPTADINE HYDROCHLORIDE TABLET [REMEDYREPACK INC.] · version 5 · 2026-04-13
- CYPROHEPTADINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.] · version 13 · 2026-02-18
- CYPROHEPTADINE HYDROCHLORIDE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.] · version 6 · 2026-01-28
- CYPROHEPTADINE HYDROCHLORIDE TABLET [QPHARMA INC] · version 2 · 2025-12-19
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.