FDA.reportPublic FDA data

NDC 62157-912 - Sertraline HCl

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
62157-912
Package NDCs from labels
62157-912-01
Manufacturer
AX Pharmaceutical Corp
Effective date
2019-09-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Sertraline HCl - AX Pharmaceutical CorpAX Pharmaceutical Corp2019-09-16BULK INGREDIENT

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 6 of 8 · 158 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.ae3be25b-2bde-4142-ad56-920a96ac8f392025-01-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
SertralineSERTRALINEBryant Ranch Prepacke0adb991-ec4e-4cd1-b54e-6d8c731a1d592025-01-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLCec1b68d3-ff55-d0a2-e053-2a95a90a2e0b2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLCf8c45a99-18ed-0e1f-e053-6394a90a2d522024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEQuality Care Products LLC25aef6c1-9964-44a1-a905-c37e5c28a3c02024-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
SertralineSERTRALINEQuality Care Products, LLC6ed2b9b7-e4af-4e28-a7d5-4ccb514af2172024-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEAmerican Health Packaging4e09f580-d612-416c-a4a4-79a4411845b22024-11-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
Sertraline hydrochlorideSERTRALINE HYDROCHLORIDEA-S Medication Solutionsf705f743-40e9-42bf-88f5-6dd7e5d5ba942024-10-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
Sertraline hydrochlorideSERTRALINE HYDROCHLORIDEA-S Medication Solutions4f6f2412-8085-45bf-be4f-63e44490a34e2024-10-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
SertralineSERTRALINEA-S Medication Solutionse93391c9-db88-4fa5-b1d5-f6c6de78b31c2024-10-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEBryant Ranch Prepack9f1d5689-3bf1-431c-9ea2-9e37217ecf402024-10-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEBryant Ranch Prepack4191b929-5bdb-4388-9e4d-fffce55bc3632024-10-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
SertralineSERTRALINEA-S Medication Solutionsf5bf9595-d9f9-40b1-9b3b-da277fd5ab7f2024-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
SertralineSERTRALINEA-S Medication Solutionsb2533b60-cc54-4905-a4ee-ea08a160f8c62024-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
Sertraline hydrochlorideSERTRALINE HYDROCHLORIDEMylan Pharmaceuticals Inc.1a58062b-e635-431a-908d-2651c6a4a21c2024-09-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDECamber Pharmaceuticals, Inc.de1f85ac-df1b-4b7b-8e18-48ebdc8b92792024-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
SertralineSERTRALINEA-S Medication Solutionscbc2bd3b-03fc-47b9-91d1-8989ec90c7e62024-08-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEBryant Ranch Prepackfa260c6c-9f6a-46a3-91ce-5665739d87e72024-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDENorthStar Rx LLC7f144b68-ae90-483c-b030-f6824662a7342024-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEBryant Ranch Prepackc6897cf2-1349-400d-ab22-1e88f097b6932024-08-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X

Reported adverse events (FAERS/openFDA)#

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