FDA.reportPublic FDA data

NDC 16729-210 - FLUOXETINE

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
16729-210
Package NDCs from labels
16729-210-10
Manufacturer
Accord Healthcare Inc. | Intas Pharmaceuticals Limited
Effective date
2023-11-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
FLUOXETINE - Accord Healthcare Inc. | Intas Pharmaceuticals LimitedAccord Healthcare Inc. | Intas Pharmaceuticals Limited2023-11-28HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16729-210-10FLUOXETINE30 in 1 BOTTLECAPSULE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-210FLUOXETINE CAPSULE [ACCORD HEALTHCARE INC.]21 package rows20240802_5d3f883a-ab3d-47e0-b24e-6f3a4e91ed70.zip

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 17 of 139 · 2,779 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Silkscreen Sheer Tint Mineral Light-MediumTITANIUM DIOXIDE, ZINC OXIDECurology4ddbe349-6880-a5fc-e063-6294a90a275c2026-03-25WarningsExact identifier
unii: 15FIX9V2JP
BANANA BOATTITANIUM DIOXIDE,ZINC OXIDEEdgewell Personal Care Brands LLC4e0450ca-147a-91d7-e063-6394a90ae73b2026-03-25WarningsExact identifier
unii: 15FIX9V2JP
Sunscreen SPF 50SUNSCREEN SPF 50Guangzhou Ariel Biotech Co., Ltd.4dd05620-30a3-9cea-e063-6294a90af18b2026-03-24WarningsExact identifier
unii: 15FIX9V2JP
Sunscreen SPF 50SUNSCREEN SPF 50Guangzhou Ariel Biotech Co., Ltd.4dd1b722-4448-9675-e063-6294a90a5f4f2026-03-24WarningsExact identifier
unii: 15FIX9V2JP
A plus AttentionBARYTA CARBONICA, CALCAREA PHOSPHORICA, SILICEA, GELSEMIUM SEMPERVIRENS, NUX VOMICA, SINAPIS NIGRANaturalCaree77c2661-7ddf-4b09-b2e3-b9db3911011a2026-03-24WarningsExact identifier
unii: ETJ7Z6XBU4
WHAMISA ORGANIC PEAR BLOSSOM SUNSCREENZINC OXIDEENS KOREA Co., Ltd.34f9688d-efa1-1d3f-e063-6294a90ab1272026-03-23WarningsExact identifier
unii: 15FIX9V2JP
HALORINNA SUN-SCREEN TRAVEL SPF50SUN SCREENGuangdong Bisutang Biotechnology Co., LTD4dade579-ce77-eea5-e063-6394a90ad46a2026-03-23WarningsExact identifier
unii: 15FIX9V2JP
FluoxetineFLUOXETINE HYDROCHLORIDEBryant Ranch Prepack3ccada47-7eb9-285d-5059-06afb44661142026-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310384
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDEBryant Ranch Prepackbb06af33-8ff7-0b02-0029-d628f62e13822026-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310385
unii: I9W7N6B1KJ
Protect by HEALTHY SKIN LAB MD SUNSCREEN TINTED MOISTURIZERTITANIUM DIOXIDE, ZINC OXIDEHEALTHY SKIN LAB LIMITED4a1ec566-549f-45f2-a43d-dacfc72633612026-03-20WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30SKNVcare, LLC4d67dfb4-3607-2af6-e063-6294a90ae01a2026-03-19WarningsExact identifier
unii: 15FIX9V2JP
Nail Fungus ControlCALENDULA OFFICINALIS FLOWERING TOP AND SILICON DIOXIDEForces of Natureb7239e23-326e-4c1d-a080-55f457f1c4542026-03-19WarningsExact identifier
unii: ETJ7Z6XBU4
FluoxetineFLUOXETINE HYDROCHLORIDEBryant Ranch Prepack77d5c10a-0cfc-4b89-942c-0fb5c67ae4092026-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 313989
unii: I9W7N6B1KJ
Premier Tinted Mineral SunscreenBROAD SPECTRUM SPF30Premier Plastic Surgery4d3a36b9-7d60-01ac-e063-6294a90af4fb2026-03-18WarningsExact identifier
unii: 15FIX9V2JP
Otoflam HPBELLADONNA, CONIUM MACULATUM, DULCAMARA, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA (VULGARIS), SILICEA, CHAMOMILLABioActive Nutritional, Inc.12f1ef62-93f3-45b8-885d-1b82f85a83552026-03-17WarningsExact identifier
unii: ETJ7Z6XBU4
OSKIN New York Coffee BB Cream SPF 30TITANIUM DIOXIDE, OCTOCRYLENE, ZINC OXIDEO'Skin Studio NY29dae75a-4368-432a-9cf8-f0f021f09e292026-03-17WarningsExact identifier
unii: 15FIX9V2JP
Premier Tinted Mineral SunscreenBROAD SPECTRUM SPF30Premier Plastic Surgery4d39b64c-2e27-afed-e063-6394a90a38122026-03-17WarningsExact identifier
unii: 15FIX9V2JP
PowderTITANIUM DIOXIDEOxygen Development LLC4d39ed7a-ca80-893c-e063-6294a90a03e72026-03-17WarningsExact identifier
unii: 15FIX9V2JP
PowderTITANIUM DIOXIDEOxygen Development LLC4d3a0a92-b0de-a1ea-e063-6294a90a85082026-03-17WarningsExact identifier
unii: 15FIX9V2JP
Coral Isle SPF 50 Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEDerma Care Research Labs, LLC0aafab44-0481-2a22-e063-6294a90abef22026-03-17WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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