FDA.reportPublic FDA data

NDC 51672-1348-08 - Escitalopram

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
51672-1348
Requested NDC
51672-1348-08
Package NDCs from labels
51672-1348-8, 51672-1348-1, 51672-1348-9, 51672-1348-08
Manufacturer
Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.
Effective date
2025-07-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Escitalopram - Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.2025-07-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-1348-1Escitalopram240 mL in 1 BOTTLESOLUTION24013
51672-1348-1Escitalopram1 in 1 CARTONSOLUTION113
51672-1348-8Escitalopram1 in 1 CARTONSOLUTION113
51672-1348-8Escitalopram120 mL in 1 BOTTLESOLUTION12013
51672-1348-9Escitalopram480 mL in 1 BOTTLESOLUTION48013
51672-1348-9Escitalopram1 in 1 CARTONSOLUTION113

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1348ESCITALOPRAM (ESCITALOPRAM OXALATE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]12Current NDC, Legacy NDC, 6 package rows20210703_c871d3fe-5ca2-410c-976d-9ec4b72c878f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1348-1ML - Milliliter51672-13488e4fe186-118e-408c-af78-78019744d31e12013-11-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Escitalopram OxalateACTIVE INGREDIENT5U85DBW7LOESCITALOPRAM (ESCITALOPRAM OXALATE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]8
EscitalopramACTIVE MOIETY4O4S742ANYESCITALOPRAM (ESCITALOPRAM OXALATE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]8
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPESCITALOPRAM (ESCITALOPRAM OXALATE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]8
glycerinINACTIVE INGREDIENTPDC6A3C0OXESCITALOPRAM (ESCITALOPRAM OXALATE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]8
malic acidINACTIVE INGREDIENT817L1N4CKPESCITALOPRAM (ESCITALOPRAM OXALATE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]8
methylparabenINACTIVE INGREDIENTA2I8C7HI9TESCITALOPRAM (ESCITALOPRAM OXALATE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]8
propylene glycolINACTIVE INGREDIENT6DC9Q167V3ESCITALOPRAM (ESCITALOPRAM OXALATE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]8
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHESCITALOPRAM (ESCITALOPRAM OXALATE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]8
sodium citrateINACTIVE INGREDIENT1Q73Q2JULRESCITALOPRAM (ESCITALOPRAM OXALATE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]8
sorbitolINACTIVE INGREDIENT506T60A25RESCITALOPRAM (ESCITALOPRAM OXALATE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]8
waterINACTIVE INGREDIENT059QF0KO0RESCITALOPRAM (ESCITALOPRAM OXALATE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]8

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 38 · 754 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Eye Drops Redness ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDECardinal Healthaee4bbe2-4f11-4c54-be8b-df48b3ba4f3a2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMRite Aid Corporation407c78ca-6fee-4ed6-b61b-711ec049c86e2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
Clear Eyes NighttimeGLYCERINPrestige Brands Holdings, Inc.af75e2f7-81dd-43e0-a390-b52bbfbebf622026-09-08WarningsExact identifier
unii: PDC6A3C0OX
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMCVS Pharmacy3167c918-a7d3-46a1-a85b-64f9c22916f22026-09-04WarningsExact identifier
unii: PDC6A3C0OX
escitalopramESCITALOPRAMREMEDYREPACK INC.d75e3b97-1ead-4e7b-9ae3-3626aede1efd2026-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 5U85DBW7LO
escitalopramESCITALOPRAMREMEDYREPACK INC.53a7e974-9945-4e42-8395-b567bf9f1c4e2026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 5U85DBW7LO
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: 6DC9Q167V3
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
unii: 6DC9Q167V3
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
unii: 6DC9Q167V3
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: PDC6A3C0OX
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
BM BM164 DROPSARUM TRYPH, CAUSTICUM, BALSAMUM PERU, HELONIAS DIO, ACID PHOS, GLYCERINUM, EQUISETUMBM Private Limited5902770f-eb01-d099-e063-6394a90ad3eb2026-08-14WarningsExact identifier
unii: PDC6A3C0OX
SYSTANE HYDRATION PF PRESERVATIVE FREEPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.8936f66f-10fe-44ab-a26e-dd8b05dfa9972026-08-10WarningsExact identifier
unii: 6DC9Q167V3
Systane Pro PFPROPYLENE GLYCOLAlcon Laboratories, Inc.23b3515f-fbe5-4398-b2df-8b2eccdd01e22026-08-10WarningsExact identifier
unii: 6DC9Q167V3
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Leader Lubricant Eye Drops 30ctPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCARDINAL HEALTH 110, LLC. DBA LEADER8df69f2c-40c4-245c-e053-2a95a90a54062026-08-05WarningsExact identifier
unii: 6DC9Q167V3
CVS GlycerinGLYCERIN SUPPOISITORYCVS Pharmacy, Incca6d13db-60e8-4fcc-b7b3-3eb280b8c4352026-08-04WarningsExact identifier
unii: PDC6A3C0OX
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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