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 4 of 275 · 5,492 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
La Vaquita New RegularMETHYL SALICYLATEDelon Laboratories (1990) Ltdd62186ac-afbb-443e-98c2-f0d122422a3c2026-09-01WarningsExact identifier
unii: L7T10EIP3A
ActivICEMENTHOLMedline Industries, LP834adeb9-38ad-0cfe-e053-2991aa0af82f2026-09-01WarningsExact identifier
unii: L7T10EIP3A
La Vaquita New ExtraMETHYL SALICYLATE, MENTHOLDelon Laboratories (1990) Ltd3097a01b-cee5-492f-b65a-63992fb28e3a2026-09-01WarningsExact identifier
unii: L7T10EIP3A
MUCINEX INSTASOOTHE SORE THROAT PLUS COUGH SUGAR FREEHEXYLRESORCINOL AND MENTHOLReckitt Benckiser LLC4a938e15-a996-8538-e063-6294a90ad4ee2026-09-01WarningsExact identifier
unii: L7T10EIP3A
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWALMART INC. (see also Equate)ceb125d9-8c1b-498c-b0f0-f18756ede4422026-09-01WarningsExact identifier
unii: L7T10EIP3A
Smart Care MISTLETOE HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.fca4510f-f130-464c-ade4-fe05bdae3e7b2026-09-01WarningsExact identifier
unii: 3K9958V90M
Orajel 4X Medicated Toothache and Gum CreamBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.5a1c82b4-02b3-d456-e063-6294a90a16bb2026-08-31WarningsExact identifier
unii: L7T10EIP3A
Orajel 4X Medicated Toothache and Gum PM CreamBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.5a1cdaf4-3388-280c-e063-6294a90ac70f2026-08-31WarningsExact identifier
unii: L7T10EIP3A
Smart Care Hand Sanitizer,2pk -Gingerbread and Cherry CobblerALCOHOLShenzhen Lantern Scicence Co.,Ltd.5a52731b-5e8c-5ae6-e063-6394a90a8b042026-08-31WarningsExact identifier
unii: 3K9958V90M
REINREUDE SMELLING SALTSMENTHOL 15% SMELLING SALTSHubei Minxin Pharmaceutical Co., Ltd.5a539219-f9b8-5e94-e063-6294a90a25932026-08-31WarningsExact identifier
unii: L7T10EIP3A
SERYNTH SMELLING SALTSMENTHOL 15% SMELLING SALTSHubei Minxin Pharmaceutical Co., Ltd.5a5405f9-9881-e547-e063-6294a90a0d102026-08-31WarningsExact identifier
unii: L7T10EIP3A
hydrating mist hand sanitizer with silicone keychain holder - beaver nuggetsALCOHOLGanzhou Olivee Cosmetic Co., Ltd.f875e065-7b3e-45dc-8a33-b893ab8306952026-08-31WarningsExact identifier
unii: 3K9958V90M
hydrating mist hand sanitizer with silicone keychain holder - signature scentALCOHOLGanzhou Olivee Cosmetic Co., Ltd.30e11bf0-1a21-45b1-adf9-cf3845419a982026-08-31WarningsExact identifier
unii: 3K9958V90M
Swisher Instant Hand Sanitizer GelALCOHOLEcolab Inc.1f84e842-ece4-4eb7-9ccf-d86cec78dbf22026-08-31WarningsExact identifier
unii: 3K9958V90M
EAYONYUMT NECK PAIN RELIEFMENTHOLWuhan Ruihengjie Technology Co., Ltd.5a450e68-07a7-a4bb-e063-6294a90a97c92026-08-30WarningsExact identifier
unii: L7T10EIP3A
EAYONYUM BACK PAIN RELIEVINGMENTHOLWuhan Ruihengjie Technology Co., Ltd.5a458280-4f9c-5af6-e063-6394a90acb2e2026-08-30WarningsExact identifier
unii: L7T10EIP3A
EAYONYUM KNEE PAIN RELIEVINGMENTHOLWuhan Ruihengjie Technology Co., Ltd.5a45d19f-c753-71eb-e063-6294a90a48052026-08-30WarningsExact identifier
unii: L7T10EIP3A
Smart Care Hand Sanitizer(Oval Shape)with Beaded Wristlet - Cherry BlossomALCOHOLShenzhen Lantern Scicence Co.,Ltd.5a4fb4b6-ba9e-5b82-e063-6294a90a47342026-08-30WarningsExact identifier
unii: 3K9958V90M
SYLVIRENE SMELLING SALTSMENTHOL 15% SMELLING SALTSHubei Minxin Pharmaceutical Co., Ltd.5a4fd689-2113-f15a-e063-6394a90a45ad2026-08-30WarningsExact identifier
unii: L7T10EIP3A
Smart Care Hand Sanitizer with Woven Lanyard and Chainendants- WatermelonALCOHOLShenzhen Lantern Scicence Co.,Ltd.5a503581-061b-0050-e063-6294a90af48a2026-08-30WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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