FDA.reportPublic FDA data

NDC 63629-9575-2 - zolmitriptan

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
63629-9575
Requested NDC
63629-9575-2
Package NDCs from labels
63629-9575-2, 63629-9575-1
Manufacturer
Bryant Ranch Prepack
Effective date
2024-08-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
zolmitriptan - Bryant Ranch PrepackBryant Ranch Prepack2024-08-14HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-9575-1zolmitriptan6 in 1 CARTONSPRAY6106
63629-9575-2zolmitriptan1 in 1 BOTTLE, SPRAYSPRAY1106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-9575ZOLMITRIPTAN SPRAY [BRYANT RANCH PREPACK]106Current NDC, Legacy NDC, 2 package rows20240816_8b4e77de-3185-4d1e-946a-96b785b76da0.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-9575-1EA - Each63629-957526f5b98c-21e1-4426-b42c-4fc285faebf612023-02-06

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 57 of 72 · 1,437 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
teruflex blood bag system with diversion blood sampling arm 70 ml cpda-1ANHYDROUS CITRIC ACID, TRISODIUM CITRATE DIHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, DEXTROSE MONOHYDRATE, AND ADENINETerumo Corporation86b3a329-c83f-4977-92f5-0e9dfe1872d72024-10-10WarningsExact identifier
unii: XF417D3PSL
WhiskCare 377 FreeBENZALKONIUM CHLORIDEWhisk Products, Inc.20c31cf2-7d01-ce84-e063-6294a90a1c3d2024-10-07WarningsExact identifier
unii: F5UM2KM3W7
Bio Co-Enzyme PhaseCARDUUS MARIANUS, ASCORBICUM ACIDUM, CYSTEINUM, NATRUM OXALACETICUM, NICOTINAMIDUM, PULSATILLA (PRATENSIS), PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, THIAMINUM HYDROCHLORICUM, ALPHA-KETOGLUTARICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, CERIUM OXALICUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MAGNESIUM OROTICUM DIHYDRICUM, MALICUM ACIDUM, NADIDUM, NATRUM PYRUVICUM, PANTOTHENIC ACID, SUCCINICUM ACIDUM, ADRENALINUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, HEPAR SULPHURIS CALCAREUM, SULPHUR, ACONITICUM ACIDUM, CIS-,Deseret Biologicals, Inc.afad858e-064f-454d-be78-da1501ffe8532024-10-04WarningsExact identifier
unii: XF417D3PSL
TERUFLEX BLOOD with Diversion Blood Sampling Arm 70 mL CPDA-1ANHYDROUS CITRIC ACID, TRISODIUM CITRATE DIHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, DEXTROSE MONOHYDRATE, AND ADENINETerumo Corporation39f2e11c-5a31-469f-b725-d096c16744212024-10-03WarningsExact identifier
unii: XF417D3PSL
DiaSincBENZALKONIUM CHLORIDEPureTek Corporationd9ba1ca8-8883-11bb-e053-2995a90a58462024-10-02WarningsExact identifier
unii: F5UM2KM3W7
GenRx Hand SanitizingBENZALKONIUM CHLORIDEPureTek Corporationa12715c0-77f2-7716-e053-2995a90a06d32024-10-02WarningsExact identifier
unii: F5UM2KM3W7
Wet Ones Antibacterial Non Plastic Hand WipesBENZALKONIUM CHLORIDEEdgewell Personal Care Brands LLCe9abef25-773e-b67f-e053-2995a90a36402024-10-01WarningsExact identifier
unii: F5UM2KM3W7
AOSI HEALTHCARE BURNLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDENantong Health & Beyond Hygienic Products Inc.a28b920c-0bb8-4b5a-addd-26ea164e036e2024-09-25WarningsExact identifier
unii: F5UM2KM3W7
TERUFLEX Blood Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) for Collection of 450mL of BloodANHYDROUS CITRIC ACID, TRISODIUM CITRATE DIHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, DEXTROSE MONOHYDRATE, AND ADENINETerumo Corporation02015040-9b71-4dbe-8f8d-e0d0951e8f932024-09-19WarningsExact identifier
unii: XF417D3PSL
Dial antibacterial and sensitive hypoallergenic barBENZALKONIUM CHLORIDEHenkel Corporation2269bac8-b724-feb8-e063-6394a90a52ff2024-09-18WarningsExact identifier
unii: F5UM2KM3W7
WhiskCare 377BENZALKONIUM CHLORIDEWhisk Products, Inc.124b403f-d12e-6e5c-e063-6394a90a63f82024-09-13WarningsExact identifier
unii: F5UM2KM3W7
Sani-Sure AFBENZALKONIUM CHLORIDEWhisk Products, Inc.215edd45-6266-0bfe-e063-6294a90ae9ea2024-09-05WarningsExact identifier
unii: F5UM2KM3W7
Thompson AntisepticBENZALKONIUM CHLORIDEThompson0c009ed0-23b8-e4b3-e063-6394a90a723d2024-09-04WarningsExact identifier
unii: F5UM2KM3W7
Bravo Sierra - Antibacterial Body WipesBENZALKONIUM CHLORIDE WIPESUnderscore USA20ed5566-9014-e35b-e063-6294a90a003a2024-08-30WarningsExact identifier
unii: F5UM2KM3W7
WhiskCare 377 FreeBENZALKONIUM CHLORIDEWhisk Products, Inc.0bf163a6-0239-932c-e063-6394a90a12ab2024-08-28WarningsExact identifier
unii: F5UM2KM3W7
Be Smart Get Prepared Burn CreamBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE ANHYDROUSTotal Resources International, Inceacb5138-4af8-4550-b883-5603ad96ed7d2024-08-16WarningsExact identifier
unii: F5UM2KM3W7
DoveCARE AND PROTECT ANTIBACTERIAL HAND WASHConopco Inc. d/b/a/ Unileverb9f65122-4037-de0b-e053-2995a90ae5102024-08-16WarningsExact identifier
unii: F5UM2KM3W7
ZolmitriptanZOLMITRIPTANZydus Lifesciences Limitedaae2d9cb-9938-4032-961f-f0afd1958b5d2024-08-14Exact identifier
unii: 2FS66TH3YW
zolmitriptanZOLMITRIPTANBryant Ranch Prepack8b4e77de-3185-4d1e-946a-96b785b76da02024-08-14Warnings, Adverse reactionsExact identifier
application number: ANDA212469
ndc (package): 63629-9575-2
ndc (package): 63629-9575-1
ndc (product): 63629-9575
ndc11 (package): 63629957502
rxcui: 402000
spl id: bf2b9204-93fa-4b0c-80a7-79e4aad901f3
spl set id: 8b4e77de-3185-4d1e-946a-96b785b76da0
unii: 2FS66TH3YW
Quality Choice Effervescent Antacid and Pain Relief - Extra StrengthASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATEChain Drug Marketing Association1f926637-a61c-8eb7-e063-6394a90a65022024-08-13WarningsExact identifier
unii: XF417D3PSL

Reported adverse events (FAERS/openFDA)#

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