FDA.reportPublic FDA data

Sertraline Hcl

Manufacturer
AX Pharmaceutical Corp | Shangyu Jingxin Pharmaceutical Co., Ltd.
Effective date
2024-10-22
Label type
BULK INGREDIENT - ANIMAL DRUG
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 20:51:35

Label at a glance#

ProductSertraline Hcl
Active ingredientSERTRALINE HYDROCHLORIDE
Label structure1 sections

Label contents#

Full prescribing information#

Sertraline Hcl

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage descriptionimage descriptionimage description

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73377-134SERTRALINE HCL POWDER [AX PHARMACEUTICAL CORP]3Unmatched20241024_d1b78368-e374-46ee-948c-404bd22fe4cd.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73377-13473377-134-01, 73377-134-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
SERTRALINE HYDROCHLORIDEUTI8907Y6XACTIM

Source Document#

Source XML

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 1 of 7 · 138 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEREMEDYREPACK INC.7d598f1a-6c76-458a-a155-7a6a0743a2d32026-09-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SERTRALINE HYDROCHLORIDE
Sertraline hydrochlorideSERTRALINE HYDROCHLORIDEREMEDYREPACK INC.455c8416-c878-4283-a42f-4df896870a4e2026-08-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SERTRALINE HYDROCHLORIDE
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.b559c20d-70be-41e7-acfb-262ffc3ea8782026-08-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SERTRALINE HYDROCHLORIDE
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.5921f77f-01a2-40b9-ad77-2258865c997d2026-08-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SERTRALINE HYDROCHLORIDE
Sertraline hydrochlorideSERTRALINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.4da914d0-629e-4766-b57f-6119fa8283cf2026-08-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SERTRALINE HYDROCHLORIDE
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.677c90cd-6527-40cb-a564-571796513fcb2026-08-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SERTRALINE HYDROCHLORIDE
Sertraline hydrochlorideSERTRALINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.1afd0016-d0ee-4e25-a1a4-b66f228e2f9c2026-08-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SERTRALINE HYDROCHLORIDE
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDECardinal Health 107, LLC7e5e76cf-2fda-4f9d-bcbf-f77b1f188ee62026-08-25Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SERTRALINE HYDROCHLORIDE
Sertraline HClSERTRALINE HYDROCHLORIDEUmedica Laboratories USA Inc.a6d0f35c-f4f4-456d-b8d9-d56297261ad62026-08-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sertraline HCl
generic name: SERTRALINE HYDROCHLORIDE
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.adfcc867-1b6e-4698-94b6-2b4190c4ba3d2026-08-07Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SERTRALINE HYDROCHLORIDE
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.52c88667-c67e-4d42-b319-afb354713b1e2026-08-07Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SERTRALINE HYDROCHLORIDE
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEProficient Rx LP9dacf5b7-1a23-4767-a074-11f26623e48b2026-08-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SERTRALINE HYDROCHLORIDE
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEREMEDYREPACK INC.91e24d17-ff0a-449c-9472-b9df74c984562026-07-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SERTRALINE HYDROCHLORIDE
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEREMEDYREPACK INC.a2f333af-d37b-4705-ab7a-d363e3186e6e2026-07-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SERTRALINE HYDROCHLORIDE
Sertraline hydrochlorideSERTRALINE HYDROCHLORIDEREMEDYREPACK INC.9d49e2cb-a852-403d-b92b-e7d3fa88032c2026-07-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SERTRALINE HYDROCHLORIDE
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.f6346a11-88b9-4425-b08d-a22f19c4ceb42026-07-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SERTRALINE HYDROCHLORIDE
SERTRALINESERTRALINE HYDROCHLORIDEA-S Medication Solutions7b5c29ff-25c8-4b68-844d-b8e95be7d09b2026-07-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SERTRALINE HYDROCHLORIDE
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDECoupler LLC56442b06-c135-a035-e063-6394a90a171b2026-07-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SERTRALINE HYDROCHLORIDE
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEUnit Dose Solutions, Inc.561a8a20-be26-c4f8-e063-6394a90af0722026-07-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SERTRALINE HYDROCHLORIDE
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEUnit Dose Solutions, Inc.561e7498-a606-366d-e063-6394a90a1c6a2026-07-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SERTRALINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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