FDA.reportPublic FDA data

NDC 63629-8774-01 - SERTRALINE 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
63629-8774
Requested NDC
63629-8774-01
Package NDCs from labels
63629-8774-1, 63629-8774-01
Manufacturer
Bryant Ranch Prepack
Effective date
2024-08-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
SERTRALINE HYDROCHLORIDE - Bryant Ranch PrepackBryant Ranch Prepack2024-08-19HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-8774-1SERTRALINE HYDROCHLORIDE1 in 1 CARTONSOLUTION1106
63629-8774-1SERTRALINE HYDROCHLORIDE60 mL in 1 BOTTLE, DROPPERSOLUTION60106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8774SERTRALINE HYDROCHLORIDE SOLUTION [BRYANT RANCH PREPACK]106Current NDC, Legacy NDC, 2 package rows20240820_fa260c6c-9f6a-46a3-91ce-5665739d87e7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8774-1ML - Milliliter63629-8774769a8c93-f42e-484d-9bab-1ae67dbe35b312022-01-06

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 2 of 13 · 255 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEREMEDYREPACK INC.a2f333af-d37b-4705-ab7a-d363e3186e6e2026-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
NeutraflushEYEWASH STATION ADDITIVE CONCENTRATEAero Healthcare1d9ff2ef-9c9b-f367-e063-6294a90afa0e2026-07-24WarningsExact identifier
unii: 6DC9Q167V3
Sertraline hydrochlorideSERTRALINE HYDROCHLORIDEREMEDYREPACK INC.9d49e2cb-a852-403d-b92b-e7d3fa88032c2026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
FUNGAL NAIL TREATMENT kit .cream.PSEUDOLARIX AMABILIS BARK 1%GETHSEMANE BRANCH CORPORATION56c9d9fa-09ad-e26a-e063-6394a90a0ed92026-07-17WarningsExact identifier
unii: 6DC9Q167V3
Eyewash Station Additive ConcentrateCHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOLGlobal Equipment Companybc93a1e8-aa3c-6735-e053-2995a90ad6e82026-07-16WarningsExact identifier
unii: 6DC9Q167V3
Revitalize Energizing Eye DropsNAPHAZOLINE HYDROCHLORIDE ,PROPYLENE GLYCOLRevitalize Energy Inc.518aac87-1642-4b2f-bca1-b74d21261eea2026-07-16WarningsExact identifier
unii: 6DC9Q167V3
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.f6346a11-88b9-4425-b08d-a22f19c4ceb42026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
SERTRALINESERTRALINE HYDROCHLORIDEA-S Medication Solutions7b5c29ff-25c8-4b68-844d-b8e95be7d09b2026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDECoupler LLC56442b06-c135-a035-e063-6394a90a171b2026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEUnit Dose Solutions, Inc.561a8a20-be26-c4f8-e063-6394a90af0722026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEUnit Dose Solutions, Inc.561e7498-a606-366d-e063-6394a90a1c6a2026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEUnit Dose Solutions, Inc.55f514c6-f6ec-13ac-e063-6294a90ac9572026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
SertralineSERTRALINESt. Mary's Medical Park Pharmacy3dd83384-09b5-da46-e063-6394a90a558c2026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
Sertraline hydrochlorideSERTRALINE HYDROCHLORIDEBryant Ranch Prepack9c0a7f78-9cac-4e82-b971-f3f9758f8a0c2026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEREMEDYREPACK INC.575da603-b038-421f-9894-6796d9ac33cc2026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
Sertraline hydrochlorideSERTRALINE HYDROCHLORIDENorthwind Health Company, LLC4ddfd698-3d47-fc0e-e063-6394a90accec2026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
Sertraline hydrochlorideSERTRALINE HYDROCHLORIDECoupler LLC544d1ed1-da06-976d-e063-6394a90afe792026-06-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEBryant Ranch Prepacke919f195-0ce1-4d71-9883-efec05b9a0502026-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDESt. Mary's Medical Park Pharmacy8d444aec-cf33-b769-e053-2995a90a54be2026-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDESt. Mary's Medical Park Pharmacy730448bf-2d78-44a4-e053-2991aa0ada9e2026-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X

Reported adverse events (FAERS/openFDA)#

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