FDA.reportPublic FDA data

NDC 0093-7198-19 - 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
0093-7198
Requested NDC
0093-7198-19
Package NDCs from labels
0093-7198-56, 0093-7198-01, 0093-7198-05, 0093-7198-19
Manufacturer
AvKARE
Effective date
2026-01-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Fluoxetine - AvKAREAvKARE2026-01-14HUMAN PRESCRIPTION DRUG LABEL
Fluoxetine - Teva Pharmaceuticals USA, Inc.Teva Pharmaceuticals USA, Inc.2025-09-30HUMAN PRESCRIPTION DRUG LABEL
Fluoxetine - Proficient Rx LPProficient Rx LP2024-10-01HUMAN PRESCRIPTION DRUG LABEL
Fluoxetine - REMEDYREPACK INC.REMEDYREPACK INC.2019-03-27HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0093-7198-01Fluoxetine100 in 1 BOTTLECAPSULE10029
0093-7198-05Fluoxetine500 in 1 BOTTLECAPSULE50029
0093-7198-56Fluoxetine30 in 1 BOTTLECAPSULE3029

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-7198FLUOXETINE CAPSULE [TEVA PHARMACEUTICALS USA, INC.]27Current NDC, Legacy NDC, 3 package rows20240918_369dbfba-9de4-433c-8680-2ec047b8f8d9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-7198-01EA - Each0093-7198abb95323-084f-4d8d-92fd-93530acaa00412012-07-24
0093-7198-05EA - Each0093-7198c7eaf276-3903-421b-87da-7a60f5ea842b12012-07-24
0093-7198-19EA - Each0093-7198030a99f1-3e81-40e4-9668-9daab5eee8ed12012-07-24
0093-7198-56EA - Each0093-71987a8b3a49-3f90-4487-88f1-e96e404e734412012-07-24
0093-7198-93EA - Each0093-7198f7a188f7-2171-42cb-93ea-efa431eb58bb12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUOXETINE HYDROCHLORIDEACTIVE INGREDIENTI9W7N6B1KJFLUOXETINE CAPSULE [TEVA PHARMACEUTICALS USA INC]13
FLUOXETINEACTIVE MOIETY01K63SUP8DFLUOXETINE CAPSULE [TEVA PHARMACEUTICALS USA INC]13
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933FLUOXETINE CAPSULE [TEVA PHARMACEUTICALS USA INC]13
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHFLUOXETINE CAPSULE [TEVA PHARMACEUTICALS USA INC]13
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GFLUOXETINE CAPSULE [TEVA PHARMACEUTICALS USA INC]13
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OFLUOXETINE CAPSULE [TEVA PHARMACEUTICALS USA INC]13
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDFLUOXETINE CAPSULE [TEVA PHARMACEUTICALS USA INC]13
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKFLUOXETINE CAPSULE [TEVA PHARMACEUTICALS USA INC]13
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAFLUOXETINE CAPSULE [TEVA PHARMACEUTICALS USA INC]13
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357FLUOXETINE CAPSULE [TEVA PHARMACEUTICALS USA INC]13
GELATININACTIVE INGREDIENT2G86QN327LFLUOXETINE CAPSULE [TEVA PHARMACEUTICALS USA INC]13
INDIGOTINDISULFONATE SODIUMINACTIVE INGREDIENTD3741U8K7LFLUOXETINE CAPSULE [TEVA PHARMACEUTICALS USA INC]13
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3FLUOXETINE CAPSULE [TEVA PHARMACEUTICALS USA INC]13
SHELLACINACTIVE INGREDIENT46N107B71OFLUOXETINE CAPSULE [TEVA PHARMACEUTICALS USA INC]13
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FLUOXETINE CAPSULE [TEVA PHARMACEUTICALS USA INC]13
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFLUOXETINE CAPSULE [TEVA PHARMACEUTICALS USA INC]13
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFLUOXETINE CAPSULE [TEVA PHARMACEUTICALS USA INC]13

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 175 · 3,500 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lymph Tonic IIECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANABioActive Nutritional, Inc.0e3265b0-b210-4a4c-80d2-8a9712981d4e2026-09-17WarningsExact identifier
unii: ETJ7Z6XBU4
La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Soothing Therapeutic MultipurposeDIMETHICONEL'Oreal USA Products Inc805cd262-2689-4818-8fed-ddefacbdde232026-09-10WarningsExact identifier
unii: 92RU3N3Y1O
La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Therapeutic MultipurposeDIMETHICONECosmetique Active Productiond19f482c-bec7-45aa-b22f-fe91a3dc717d2026-09-10WarningsExact identifier
unii: 92RU3N3Y1O
FluoxetineFLUOXETINE HYDROCHLORIDEREMEDYREPACK INC.a08dadff-f209-48dc-b597-6f085be136402026-09-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
MedlineDIMETHICONEMedline Industries, LP5afb3595-f014-153e-e063-6294a90ad34b2026-09-08WarningsExact identifier
unii: 92RU3N3Y1O
MedlineDIMETHICONEMedline Industries, LP5afb59b4-491c-45bb-e063-6294a90a0ae62026-09-08WarningsExact identifier
unii: 92RU3N3Y1O
Gas Relief Mint FlavorSIMETHICONERaritan Pharmaceuticals Inc329388cb-3ca1-4ecb-8b50-b1f9e00525592026-09-08WarningsExact identifier
unii: 92RU3N3Y1O
Psoriasis ControlCENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature2db33771-0bb9-49f8-84fa-dddc28e4ba262026-09-04WarningsExact identifier
unii: ETJ7Z6XBU4
Simethicone 125MG Gas ReliefSIMETHICONE 125 MGOne2Zee Limited Liability Company0df348bf-5a07-4f36-ae70-ca2961a9ce7e2026-09-04WarningsExact identifier
unii: 92RU3N3Y1O
anti diarrheal anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONERite Aid Corporation8e954f86-bc15-45e2-9274-ca5d8a7c96872026-09-04WarningsExact identifier
unii: 92RU3N3Y1O
Infants Gas Relief DropsSIMETHICONEDOLGENCORP INC6b132ac0-e8eb-4199-85ad-5976558ee9c82026-09-03WarningsExact identifier
unii: 92RU3N3Y1O
DG HEALTH Liquid Antacid plus Anti GasCALCIUM CARBONATE, MAGNESIUM HYDROXIDE AND SIMETHICONEDOLGENCORP, LLC8ecb4418-e647-49b5-b418-1c63bb3e5a3c2026-09-03WarningsExact identifier
unii: 92RU3N3Y1O
Simethicone DropsSIMETHICONE DROPSEverpharm LLC5a6d2c1f-4067-969f-e063-6394a90aa83f2026-09-02WarningsExact identifier
unii: 92RU3N3Y1O
TEENY TUMMY Gas Relief DropsSIMETHICONEAkron Pharmadcdd0daf-5ef0-4cb2-872d-89ed6e9f6d602026-09-01WarningsExact identifier
unii: 92RU3N3Y1O
Aloetouch Protect Fragrance FreeDIMETHICONEMedline Industries, LP81f0071b-2bf3-455b-9e5d-8f3ca20adcdf2026-09-01WarningsExact identifier
unii: 92RU3N3Y1O
SILICONE SCARDIMETHICONEHaikou Flash Purchase Star Cross-Border Trade Co., Ltd.5a7727d1-09d1-3cb3-e063-6294a90a1bc52026-09-01WarningsExact identifier
unii: 92RU3N3Y1O
Kroger Extra StrengthSIMETHICONE ANTIGASKROGER COMPANY67ddce93-4d68-4280-bf8b-337b91ab8c8f2026-09-01WarningsExact identifier
unii: 92RU3N3Y1O
Gas ReliefSIMETHICONEUnited Natural Foods, Inc. dba UNFI011859d8-3d0f-4ca7-a98b-4150054154dc2026-09-01WarningsExact identifier
unii: 92RU3N3Y1O
Kroger Extra Strength Gas ReliefSIMETHICONE ANTIGASKROGER COMPANY6aa691e4-3179-4cf7-855a-e44f16904c1c2026-09-01WarningsExact identifier
unii: 92RU3N3Y1O

Reported adverse events (FAERS/openFDA)#

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