FDA.reportPublic FDA data

NDC 50268-201-11 - Cyproheptadine Hydrochloride

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
50268-201
Requested NDC
50268-201-11
Package NDCs from labels
50268-201-11, 50268-201-15
Manufacturer
AvPAK
Effective date
2025-10-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Cyproheptadine Hydrochloride - AvPAKAvPAK2025-10-30HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50268-201-11Cyproheptadine Hydrochloride1 in 1 BLISTER PACKTABLET11
50268-201-15Cyproheptadine Hydrochloride50 in 1 BOXTABLET501

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-201-11EA - Each50268-201f3f9e5db-6b96-4aba-bf52-8f2ef92fafe212025-12-16
50268-201-15EA - Each50268-20182a2d7d1-4f63-4f74-b59b-6ffecf0257cc12025-12-16

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 2 · 39 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cyproheptadine HydrochlorideCYPROHEPTADINE HYDROCHLORIDETRUPHARMA, LLC9c0b47c0-ecd2-450f-9dcb-c262db92866e2026-08-20Warnings, Adverse reactionsExact identifier
rxcui: 866144
unii: NJ82J0F8QC
Cyproheptadine HydrochlorideCYPROHEPTADINE HYDROCHLORIDEBryant Ranch Prepackdd2f3f0e-1bb8-432b-bcbb-01b4f550d0222026-08-17Warnings, Adverse reactionsExact identifier
rxcui: 866144
unii: NJ82J0F8QC
CYPROHEPTADINE HYDROCHLORIDECYPROHEPTADINE HYDROCHLORIDEAtlantic Biologicals Corp.582b86c6-f9b2-278d-e063-6394a90a923d2026-08-07Warnings, Adverse reactionsExact identifier
unii: NJ82J0F8QC
Cyproheptadine HydrochlorideCYPROHEPTADINE HYDROCHLORIDETRUPHARMA, LLC1d668d93-8c9e-479e-ad8d-59656c8dec1b2026-07-14Warnings, Adverse reactionsExact identifier
rxcui: 866144
unii: NJ82J0F8QC
Cyproheptadine HydrochlorideCYPROHEPTADINE HYDROCHLORIDEREMEDYREPACK INC.80411af3-03ee-4330-830b-f69f2a373ef92026-06-01Warnings, Adverse reactionsExact identifier
application number: ANDA040537
rxcui: 866144
unii: NJ82J0F8QC
Cyproheptadine HydrochlorideCYPROHEPTADINE HYDROCHLORIDEAtlantic Biological Corp.50b3abc0-d86a-e8f5-e063-6394a90ad25e2026-04-30Warnings, Adverse reactionsExact identifier
unii: NJ82J0F8QC
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ
CYPROHEPTADINE HYDROCHLORIDECYPROHEPTADINE HYDROCHLORIDEREMEDYREPACK INC.7b3aed50-cc9e-4897-9735-361225e9e5f22026-04-10Warnings, Adverse reactionsExact identifier
rxcui: 866144
unii: NJ82J0F8QC
CYPROHEPTADINE HYDROCHLORIDECYPROHEPTADINE HYDROCHLORIDEStrides Pharma Science Limitedb28c2ca0-140d-44d8-a59e-75fbfe8eabdd2026-03-06Warnings, Adverse reactionsExact identifier
rxcui: 866144
unii: NJ82J0F8QC
Cyproheptadine HydrochlorideCYPROHEPTADINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.03e69414-8a25-4ed8-b7ac-16445b879b1f2026-02-16Warnings, Adverse reactionsExact identifier
rxcui: 866144
unii: NJ82J0F8QC
Cyproheptadine HydrochlorideCYPROHEPTADINE HYDROCHLORIDEUNICHEM PHARMACEUTICALS (USA), INC.99fb821a-fe33-4468-9026-9729a8deff082026-01-22Warnings, Adverse reactionsExact identifier
rxcui: 866144
unii: NJ82J0F8QC
Lotrimin Daily Sweat and Odor ControlTOPICAL STARCHBayer HealthCare LLC.9ec5c80d-b550-496f-e053-2a95a90a54892026-01-16WarningsExact identifier
unii: O8232NY3SJ
Medicated Cornstarch Baby PowderACTIVE CORN STARCHDavion, Inc.e39032d1-c8cd-4a41-af10-126970b8ad382025-12-29WarningsExact identifier
unii: O8232NY3SJ
Cyproheptadine HydrochlorideCYPROHEPTADINE HYDROCHLORIDEAmneal Pharmaceuticals of New York LLC80e13d3f-f4db-4bb4-95d5-5ac1afa70e7e2025-12-22Warnings, Adverse reactionsExact identifier
application number: ANDA040537
ndc (product): 0115-1757
rxcui: 866144
spl id: f4a945a1-a20b-4b93-858a-856db91dd601
spl set id: 80e13d3f-f4db-4bb4-95d5-5ac1afa70e7e
unii: NJ82J0F8QC
Cyproheptadine HydrochlorideCYPROHEPTADINE HYDROCHLORIDEQPharma Incfc75bd79-63b7-6388-e053-6394a90ac3772025-12-02Warnings, Adverse reactionsExact identifier
rxcui: 866144
unii: NJ82J0F8QC
CYPROHEPTADINE HYDROCHLORIDECYPROHEPTADINE HYDROCHLORIDEQPharma Inc1dfe4478-76d9-9b8f-e063-6394a90aefe82025-12-01Warnings, Adverse reactionsExact identifier
rxcui: 866144
unii: NJ82J0F8QC
CYPROHEPTADINE HYDROCHLORIDECYPROHEPTADINE HYDROCHLORIDEBryant Ranch Prepack22eaef18-b5cc-421a-910e-d569f00b45992025-11-10Warnings, Adverse reactionsExact identifier
rxcui: 866144
unii: NJ82J0F8QC
Cyproheptadine HydrochlorideCYPROHEPTADINE HYDROCHLORIDEAvPAK426acecc-aef4-099c-e063-6294a90a54eb2025-10-30Warnings, Adverse reactionsExact identifier
application number: ANDA040537
ndc (package): 50268-201-15
ndc (package): 50268-201-11
ndc (product): 50268-201
ndc11 (package): 50268020111
rxcui: 866144
spl id: 426ac91c-cb7d-1fe3-e063-6394a90a1d4d
spl set id: 426acecc-aef4-099c-e063-6294a90a54eb
unii: NJ82J0F8QC
CYPROHEPTADINE HYDROCHLORIDECYPROHEPTADINE HYDROCHLORIDEGolden State Medical Supply, Inc.95c03949-0e9a-e3b5-e053-2995a90a56b62025-08-06Warnings, Adverse reactionsExact identifier
rxcui: 866144
unii: NJ82J0F8QC

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.