FDA.reportPublic FDA data

NDC 50090-5491-01 - 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
50090-5491
Requested NDC
50090-5491-01
Package NDCs from labels
50090-5491-0, 50090-5491-1, 50090-5491-01
Manufacturer
A-S Medication Solutions
Effective date
2023-09-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Cyproheptadine Hydrochloride - A-S Medication SolutionsA-S Medication Solutions2023-09-18Human Prescription Drug Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
50090-5491-02023-02-07CYPROHEPTADINE HYDROCHLORIDE TABLETS USP
50090-5491-12023-02-07CYPROHEPTADINE HYDROCHLORIDE TABLETS USP
50090-5491-02023-01-30CYPROHEPTADINE HYDROCHLORIDE TABLETS USP
50090-5491-12023-01-30CYPROHEPTADINE HYDROCHLORIDE TABLETS USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5491-0Cyproheptadine Hydrochloride100 in 1 BOTTLETABLET1004
50090-5491-1Cyproheptadine Hydrochloride30 in 1 BOTTLETABLET304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5491CYPROHEPTADINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]4Current NDC, Legacy NDC, 2 package rows20230919_7e156e5e-e4cc-420b-8f1a-af123eaa9156.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5491-1EA - Each50090-5491dcdc515e-deb0-48bf-b4b8-189216fce10212023-10-16

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 2 of 2 · 34 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CYPROHEPTADINE HYDROCHLORIDECYPROHEPTADINE HYDROCHLORIDEZydus Lifesciences Limitedccd7d3b2-b0c1-4f66-8d06-d21f5cfa8c1e2024-11-26Exact identifier
rxcui: 866144
unii: NJ82J0F8QC
CYPROHEPTADINE HYDROCHLORIDECYPROHEPTADINE HYDROCHLORIDEBryant Ranch Prepack5d0db096-f35d-4065-bff1-2fd7ef5a1a6f2024-08-20Warnings, Adverse reactionsExact identifier
rxcui: 866144
unii: NJ82J0F8QC
CYPROHEPTADINE HYDROCHLORIDECYPROHEPTADINE HYDROCHLORIDEQUAGEN PHARMACEUTICALS LLCd3ce21de-849a-47ab-8405-968d8de6f1e92024-06-15Warnings, Adverse reactionsExact identifier
unii: NJ82J0F8QC
Cyproheptadine HydrochlorideCYPROHEPTADINE HYDROCHLORIDEBryant Ranch Prepack6a5b5a89-82c2-4991-b026-d160d8fa59a32024-05-23Warnings, Adverse reactionsExact identifier
rxcui: 866144
unii: NJ82J0F8QC
CYPROHEPTADINE HYDROCHLORIDECYPROHEPTADINE HYDROCHLORIDEBryant Ranch Prepackab58d4df-69d4-43ac-ac6c-871fcc6c946d2023-11-28Warnings, Adverse reactionsExact identifier
rxcui: 866144
unii: NJ82J0F8QC
CYPROHEPTADINE HYDROCHLORIDECYPROHEPTADINE HYDROCHLORIDEA-S Medication Solutions0e43e99b-2e0b-4f55-b93a-a6908634880d2023-11-02Warnings, Adverse reactionsExact identifier
rxcui: 866144
unii: NJ82J0F8QC
CYPROHEPTADINECYPROHEPTADINE HYDROCHLORIDEChartwell RX, LLC37fe7264-4d45-4d6c-ac13-40fcd1d823512023-10-05Warnings, Adverse reactionsExact identifier
unii: NJ82J0F8QC
Cyproheptadine HydrochlorideCYPROHEPTADINE HYDROCHLORIDEA-S Medication Solutions7e156e5e-e4cc-420b-8f1a-af123eaa91562023-09-18Warnings, Adverse reactionsExact identifier
application number: ANDA206553
ndc (package): 50090-5491-0
ndc (package): 50090-5491-1
ndc (product): 50090-5491
ndc11 (package): 50090549101
rxcui: 866144
spl id: 28b91c2a-e33a-4b09-8636-4c53ea6f1358
spl set id: 7e156e5e-e4cc-420b-8f1a-af123eaa9156
unii: NJ82J0F8QC
CYPROHEPTADINE HYDROCHLORIDECYPROHEPTADINE HYDROCHLORIDEBryant Ranch Prepack1bfb14ad-b522-4ad6-8c9f-2d99dd0dce642023-08-15Warnings, Adverse reactionsExact identifier
rxcui: 866144
unii: NJ82J0F8QC
Cyproheptadine HydrochlorideCYPROHEPTADINE HYDROCHLORIDEChartwell RX, LLC029ed3b6-175e-4a1a-81ed-350bff5f61672023-01-27Warnings, Adverse reactionsExact identifier
rxcui: 866144
unii: NJ82J0F8QC
CYPROHEPTADINE HYDROCHLORIDECYPROHEPTADINE HYDROCHLORIDEZydus Pharmaceuticals USA Inc.766f9b59-2c72-45ac-af09-5dd6c3e16b522022-10-04Warnings, Adverse reactionsExact identifier
rxcui: 866144
unii: NJ82J0F8QC
CYPROHEPTADINE HYDROCHLORIDECYPROHEPTADINE HYDROCHLORIDEQUAGEN PHARMACEUTICALS LLC98e71865-83dd-4e29-8308-c56e36731d962022-07-08Warnings, Adverse reactionsExact identifier
rxcui: 866144
unii: NJ82J0F8QC
Cyproheptadine HydrochlorideCYPROHEPTADINE HYDROCHLORIDETris Pharma Inc2b438746-14c2-44ef-a127-62b8d2efdc552022-03-15Warnings, Adverse reactionsExact identifier
unii: NJ82J0F8QC
Cyproheptadine HydrochlorideCYPROHEPTADINE HYDROCHLORIDERising Pharma Holdings, Inc.c5e9e983-d0d2-4f87-beae-0d853ca439832022-02-08Warnings, Adverse reactionsExact identifier
rxcui: 866144
unii: NJ82J0F8QC

Reported adverse events (FAERS/openFDA)#

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