FDA.reportPublic FDA data

NDC 59762-0067-01 - 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
59762-0067
Requested NDC
59762-0067-01
Package NDCs from labels
59762-0067-1, 59762-0067-01
Manufacturer
Mylan Pharmaceuticals Inc.
Effective date
2024-09-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Sertraline hydrochloride - Mylan Pharmaceuticals Inc.Mylan Pharmaceuticals Inc.2024-09-15HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59762-0067-1Sertraline hydrochloride1 in 1 CARTONSOLUTION, CONCENTRATE141
59762-0067-1Sertraline hydrochloride60 mL in 1 BOTTLE, DROPPERSOLUTION, CONCENTRATE6041

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59762-0067SERTRALINE HYDROCHLORIDE SOLUTION, CONCENTRATE [MYLAN PHARMACEUTICALS INC.]41Current NDC, Legacy NDC, 2 package rows20250504_1a58062b-e635-431a-908d-2651c6a4a21c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59762-0067-1ML - Milliliter59762-006743991f2b-9966-4066-a8f1-63ef2e5f197c12018-06-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SERTRALINE HYDROCHLORIDEACTIVE INGREDIENTUTI8907Y6XSERTRALINE HYDROCHLORIDE TABLET, FILM COATED SERTRALINE HYDROCHLORIDE SOLUTION, CONCENTRATE [GREENSTONE LLC]24
SERTRALINEACTIVE MOIETYQUC7NX6WMBSERTRALINE HYDROCHLORIDE TABLET, FILM COATED SERTRALINE HYDROCHLORIDE SOLUTION, CONCENTRATE [GREENSTONE LLC]24
ALCOHOLINACTIVE INGREDIENT3K9958V90MSERTRALINE HYDROCHLORIDE TABLET, FILM COATED SERTRALINE HYDROCHLORIDE SOLUTION, CONCENTRATE [GREENSTONE LLC]24
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933SERTRALINE HYDROCHLORIDE TABLET, FILM COATED SERTRALINE HYDROCHLORIDE SOLUTION, CONCENTRATE [GREENSTONE LLC]24
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KSERTRALINE HYDROCHLORIDE TABLET, FILM COATED SERTRALINE HYDROCHLORIDE SOLUTION, CONCENTRATE [GREENSTONE LLC]24
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPSERTRALINE HYDROCHLORIDE TABLET, FILM COATED SERTRALINE HYDROCHLORIDE SOLUTION, CONCENTRATE [GREENSTONE LLC]24
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USERTRALINE HYDROCHLORIDE TABLET, FILM COATED SERTRALINE HYDROCHLORIDE SOLUTION, CONCENTRATE [GREENSTONE LLC]24
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GSERTRALINE HYDROCHLORIDE TABLET, FILM COATED SERTRALINE HYDROCHLORIDE SOLUTION, CONCENTRATE [GREENSTONE LLC]24
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDSERTRALINE HYDROCHLORIDE TABLET, FILM COATED SERTRALINE HYDROCHLORIDE SOLUTION, CONCENTRATE [GREENSTONE LLC]24
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKSERTRALINE HYDROCHLORIDE TABLET, FILM COATED SERTRALINE HYDROCHLORIDE SOLUTION, CONCENTRATE [GREENSTONE LLC]24
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOASERTRALINE HYDROCHLORIDE TABLET, FILM COATED SERTRALINE HYDROCHLORIDE SOLUTION, CONCENTRATE [GREENSTONE LLC]24
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSERTRALINE HYDROCHLORIDE TABLET, FILM COATED SERTRALINE HYDROCHLORIDE SOLUTION, CONCENTRATE [GREENSTONE LLC]24
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSERTRALINE HYDROCHLORIDE TABLET, FILM COATED SERTRALINE HYDROCHLORIDE SOLUTION, CONCENTRATE [GREENSTONE LLC]24
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PSERTRALINE HYDROCHLORIDE TABLET, FILM COATED SERTRALINE HYDROCHLORIDE SOLUTION, CONCENTRATE [GREENSTONE LLC]24
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSERTRALINE HYDROCHLORIDE TABLET, FILM COATED SERTRALINE HYDROCHLORIDE SOLUTION, CONCENTRATE [GREENSTONE LLC]24
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SERTRALINE HYDROCHLORIDE TABLET, FILM COATED SERTRALINE HYDROCHLORIDE SOLUTION, CONCENTRATE [GREENSTONE LLC]24
MENTHOL, UNSPECIFIED FORMINACTIVE INGREDIENTL7T10EIP3ASERTRALINE HYDROCHLORIDE TABLET, FILM COATED SERTRALINE HYDROCHLORIDE SOLUTION, CONCENTRATE [GREENSTONE LLC]24
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASERTRALINE HYDROCHLORIDE TABLET, FILM COATED SERTRALINE HYDROCHLORIDE SOLUTION, CONCENTRATE [GREENSTONE LLC]24
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HSERTRALINE HYDROCHLORIDE TABLET, FILM COATED SERTRALINE HYDROCHLORIDE SOLUTION, CONCENTRATE [GREENSTONE LLC]24
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSERTRALINE HYDROCHLORIDE TABLET, FILM COATED SERTRALINE HYDROCHLORIDE SOLUTION, CONCENTRATE [GREENSTONE LLC]24

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 275 · 5,492 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sweethearts - UR Sweet - Sweet Cherry Hand SanitizerALCOHOLScent Theory Products LLC5ac33b21-9192-8baa-e063-6294a90a6e752026-09-05WarningsExact identifier
unii: 3K9958V90M
Sweethearts - Ooo La La - Banana Cream Hand SanitizerALCOHOLScent Theory Products LLC5ac34dda-fbdf-0ca7-e063-6394a90ab7642026-09-05WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Salted Caramel Scented Hydrating Hand sanitizerALCOHOLChurch & Dwight Co., Inc.5aaa5f5b-7a8b-e887-e063-6294a90a9be52026-09-04WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Peppermint Mocha Scented Hydrating Hand sanitizerALCOHOLChurch & Dwight Co., Inc.5aaa72fe-7667-fb21-e063-6294a90a5e112026-09-04WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Spiced Pumpkin tini Scented Hydrating Hand sanitizerALCOHOLChurch & Dwight Co., Inc.5aaa809e-71b8-7498-e063-6394a90a9ff82026-09-04WarningsExact identifier
unii: 3K9958V90M
Touchland Hello Kitty Power Mist Hand Sanitizer Berry BlissALCOHOLChurch & Dwight Co., Inc.5aaa8d3c-e386-1527-e063-6294a90a07ac2026-09-04WarningsExact identifier
unii: 3K9958V90M
Nerve Guard Nerve ReliefLIDOCAINE HYDROCHLORIDE, MENTHOL,MAGNESIUM CHLORIDEMicelle Laboratories, Incorporated6b78f40f-2a7f-4c49-96af-1a95acbf430f2026-09-04WarningsExact identifier
unii: L7T10EIP3A
Touchland Power Mist Hydrating Hand Sanitizer Cinnamon GingerbreadALCOHOLChurch & Dwight Co., Inc.5aaa9d84-3f84-223e-e063-6294a90a79fb2026-09-04WarningsExact identifier
unii: 3K9958V90M
Disney Touchland Power Mist Hydrating Hand Sanitizer Wild WatermelonALCOHOLChurch & Dwight Co., Inc.5aaab1c9-c25c-344a-e063-6294a90a228d2026-09-04WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hydrating Hand Sanitizer Confetti CakeALCOHOLChurch & Dwight Co., Inc.5aaacef6-3b8b-ace4-e063-6394a90ab8592026-09-04WarningsExact identifier
unii: 3K9958V90M
Disney Touchland Power Mist Hydrating Hand Sanitizer Vanilla BlossomALCOHOLChurch & Dwight Co., Inc.5aaae919-4adc-c146-e063-6394a90a89042026-09-04WarningsExact identifier
unii: 3K9958V90M
Kuromi Touchland Power Mist Hydrating Hand Sanitizer Cotton CandyALCOHOLChurch & Dwight Co., Inc.5aaaf5a5-d43f-cf23-e063-6394a90a72ef2026-09-04WarningsExact identifier
unii: 3K9958V90M
Peanuts Touchland Power Mist Hydrating Hand Sanitizer Beach CocoALCOHOLChurch & Dwight Co., Inc.5aaaff8f-5f6b-d575-e063-6394a90a1edc2026-09-04WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hydrating Hand Sanitizer Mist Midnight SmoresALCOHOLChurch & Dwight Co., Inc.5aab0ca1-b3c4-964f-e063-6294a90a263f2026-09-04WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hydrating Hand Sanitizer Mist Cranberry FizzALCOHOLChurch & Dwight Co., Inc.5aab1faa-d884-1a55-e063-6394a90ad6e22026-09-04WarningsExact identifier
unii: 3K9958V90M
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMCVS Pharmacy3167c918-a7d3-46a1-a85b-64f9c22916f22026-09-04WarningsExact identifier
unii: PDC6A3C0OX
EquateETHYL ALCOHOLWal-Mart Stores Inc.ed3796ee-3078-e850-e053-2a95a90a318a2026-09-03WarningsExact identifier
unii: 3K9958V90M
EquateETHYL ALCOHOLWal-Mart Stores Inc.ed63bd55-941f-9785-e053-2995a90a59522026-09-03WarningsExact identifier
unii: 3K9958V90M
Equate Menthol Pain RelievingMENTHOLWal-Mart Stores Incd5b0a7f1-4e23-426b-bb7e-aaa251ad4ffc2026-09-03WarningsExact identifier
unii: L7T10EIP3A
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEREMEDYREPACK INC.7d598f1a-6c76-458a-a155-7a6a0743a2d32026-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X

Reported adverse events (FAERS/openFDA)#

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