FDA.reportPublic FDA data

NDC 70771-1076-01 - 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
70771-1076
Requested NDC
70771-1076-01
Package NDCs from labels
70771-1076-1, 70771-1076-0, 70771-1076-01
Manufacturer
Zydus Lifesciences Limited
Effective date
2024-11-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
CYPROHEPTADINE HYDROCHLORIDE - Zydus Lifesciences LimitedZydus Lifesciences Limited2024-11-26HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70771-1076-0CYPROHEPTADINE HYDROCHLORIDE1000 in 1 BOTTLETABLET10005
70771-1076-1CYPROHEPTADINE HYDROCHLORIDE100 in 1 BOTTLETABLET1005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1076CYPROHEPTADINE HYDROCHLORIDE TABLET [ZYDUS LIFESCIENCES LIMITED]5Current NDC, Legacy NDC, 2 package rows20241130_ccd7d3b2-b0c1-4f66-8d06-d21f5cfa8c1e.zip

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
application number: ANDA208938
ndc (package): 70771-1076-1
ndc (package): 70771-1076-0
ndc (product): 70771-1076
ndc11 (package): 70771107601
rxcui: 866144
spl id: 465671c3-1e82-41d6-8ce4-b524d0032b15
spl set id: ccd7d3b2-b0c1-4f66-8d06-d21f5cfa8c1e
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
application number: ANDA208938
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
rxcui: 866144
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
application number: ANDA208938
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.