NDC 16729-208 - 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: 16729-208
Package NDCs from labels: 16729-208-00
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
Label	Manufacturer	Effective date	Type
FLUOXETINE - Accord Healthcare Inc. \| Intas Pharmaceuticals Limited	Accord Healthcare Inc. \| Intas Pharmaceuticals Limited	2023-11-28	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
16729-208-00	FLUOXETINE	100 in 1 BOTTLE	CAPSULE	100		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16729-208	FLUOXETINE CAPSULE [ACCORD HEALTHCARE INC.]	2	1 package rows	20240802_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 126 of 137 · 2,726 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Anubis Barcelona Total Hydrating	BETAINE, GLYCERIN, POLYSORBATE 20	ANUBIS COSMETICS SL	eaefe3b9-9064-18b1-e053-2a95a90a5765	2023-09-01	Warnings	Exact identifier unii: H3R47K3TBD
Anubis Barcelona New Even	LACTIC ACID, CITRIC ACID, GLYCOLIC ACID	ANUBIS COSMETICS SL	eaeeb6e0-5322-20c4-e053-2995a90a9fd9	2023-09-01	Warnings	Exact identifier unii: H3R47K3TBD
Hydrate II	COFFEA TOSTA, AVENA SATIVA, EQUISETUM HYEMALE, HYPERICUM PERFORMATUM, GINKGO BILOBA, GERMANIUM SESQUIOXIDE, SILICEA	BioActive Nutritional, Inc.	2d3657d9-d4f4-426c-b381-dbfde9b8e2cd	2023-09-01	Warnings	Exact identifier unii: ETJ7Z6XBU4
Fluoxetine	FLUOXETINE	Dr.Reddy's Laboratories Limited	11544dea-2f5e-1536-584a-5d1f37a99770	2023-08-31	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: I9W7N6B1KJ
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Lannett Company, Inc.	c856d72f-4a1a-4f75-ae54-c4ac83ddcfa1	2023-08-28	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: I9W7N6B1KJ
BABY MUCUS PLUS COLD RELIEF	BRYONIA ALBA ROOT, EUPHRASIA STRICTA, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PULSATILLA, RUMEX CRISPUS ROOT, AND SILICON DIOXIDE	Hyland's Inc.	d934cc8a-1e43-4942-858a-05b5d068679a	2023-08-22	Warnings	Exact identifier unii: ETJ7Z6XBU4
B HP	APIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), LACHESIS MUTUS, MERCURIUS SOLUBILIS, PULSATILLA (VULGARIS), PYROGENIUM, RHUS TOX, SILICEA	Energique, Inc.	8b1414d5-57d8-46d5-b4be-3011429bdd0d	2023-08-21	Warnings	Exact identifier unii: ETJ7Z6XBU4
Pituistat	ARALIA QUINQUEFOLIA, GINKGO BILOBA, ARSENICUM IODATUM, AVENA SATIVA, BARYTA CARBONICA, PHOSPHORUS, SILICEA, THYROIDINUM (SUIS), ALUMINUM, ANTIMONY, BARIUM, BERYLLIUM, BISMUTH, BORON, BROMINE, CALCIUM, CARBON, CERIUM, CESIUM, CHLORIDE, CHROMIUM, COBALT, COPPER, DYSPROSIUM, ERBIUM, EUROPIUM, FLUORIDE, GADOLINIUM, GALLIUM, GERMANIUM, GOLD, HAFNIUM, HOLMIUM, INDIUM, IODINE, IRIDIUM, IRON, LANTHANUM, LITHIUM, LUTETIUM, MAGNESIUM, MANGANESE, MOLYBDENUM, NEODYMIUM, NICKEL, NIOBIUM, OSMIUM, PALLADIUM	Energique, Inc.	27a5fccb-8707-4bb5-a848-d1921bba2f7f	2023-08-21	Warnings	Exact identifier unii: ETJ7Z6XBU4
Cellergy	CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, FERRUM PHOSPHORICUM, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, SILICEA.	Ratis, LLC	2aebc11e-eeb7-436b-b90c-3a2f59fb7492	2023-08-07	Warnings	Exact identifier unii: ETJ7Z6XBU4
Fluoxetine	FLUOXETINE HYDROCHLORIDE	A-S Medication Solutions	a5d49dee-a7de-44d8-80b5-1aeb89e76938	2023-08-05	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 310385 unii: I9W7N6B1KJ
Fluoxetine	FLUOXETINE	Teva Pharmaceuticals USA, Inc.	06d71a33-5578-4012-b11d-764f45bc1e6a	2023-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 310384 rxcui: 310385 unii: I9W7N6B1KJ
Fluoxetine Hydrochloride	FLUOXETINE HYDROCHLORIDE	Lupin Pharmaceuticals, Inc.	dd659085-c32d-4d35-9d4b-bafa2a93f1fb	2023-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: I9W7N6B1KJ
Fluoxetine	FLUOXETINE	Alembic Pharmaceuticals Inc.	e9ee6e93-4a57-4fd1-a417-3944484dd32c	2023-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: I9W7N6B1KJ
Fluoxetine	FLUOXETINE	Dr.Reddy's Laboratories Inc.	390c61e6-14dd-4391-45b8-0fb5f4652723	2023-07-31	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: I9W7N6B1KJ
MEB Puri-Mega	MEB PURI-MEGA	Kadesh Incoporation Co,Ltd	018125f2-ad4b-b38a-e063-6294a90a7f6e	2023-07-27	Warnings	Exact identifier unii: ETJ7Z6XBU4
VACC HC	HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, THUJA OCCIDENTALIS, RNA, ECHINACEA (ANGUSTIFOLIA), LEDUM PALUSTRE, MEZEREUM, SILICEA, INFLUENZINUM (2021-2022), ANTIMONIUM TARTARICUM, ARSENICUM ALBUM, BRYONIA (ALBA), GELSEMIUM SEMPERVIRENS, HYOSCYAMUS NIGER, LAC FELINUM, MERCURIUS SOLUBILIS, NICOTINAMIDUM, SENEGA OFFICINALIS, SPIGELIA ANTHELMIA, SULPHUR, ZINCUM METALLICUM	Deseret Biologicals, Inc.	c100d87b-4d67-42ef-b7e2-fd3642a104b8	2023-07-18	Warnings	Exact identifier unii: ETJ7Z6XBU4
Silicea	SILICEA	Ratis, LLC	8c2b59e1-9936-486c-9a91-153e46f377e6	2023-07-13	Warnings	Exact identifier unii: ETJ7Z6XBU4
Pneumotox	TRITICUM AESTIVUM, ALFALFA, ARNICA MONTANA, ASCLEPIAS TUBEROSA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), EUCALYPTUS GLOBULUS, FUCUS VESICULOSUS, HORDEUM VULGARE, IODIUM, NASTURTIUM AQUATICUM, PLANTAGO MAJOR, RAPHANUS SATIVUS, TRIFOLIUM PRATENSE, TRIGONELLA FOENUM-GRAECUM, SYMPHYTUM OFFICINALE, LUNG (SUIS), ORYZA SATIVA, SILICEA, ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ARSENICUM ALBUM, NATRUM MURIATICUM, NITRICUM ACIDUM,	BioActive Nutritional, Inc.	f8846fb1-92e5-4f8e-b3b3-bc620df90a62	2023-07-12	Warnings	Exact identifier unii: ETJ7Z6XBU4
Silicea	SILICON DIOXIDE	Boiron	ce6a0710-7c28-11e6-86bf-424c58303031	2023-07-11		Exact identifier unii: ETJ7Z6XBU4
Kidney Drainage	SOLIDAGO VIRGAUREA, ASPARAGUS OFFICINALIS, JUNIPERUS COMMUNIS, SABAL SERRULATA, UVA-URSI, BERBERIS VULGARIS, EQUISETUM ARVENSE, URTICA DIOICA, RUBIA TINCTORUM, STAPHYSAGRIA, CANTHARIS, FAGUS SYLVATICA, FLOS, GLANDULA SUPRARENALIS SUIS, HEPAR SULPHURIS CALCAREUM, KIDNEY (SUIS), LARIX DECIDUA, FLOS, MANGANUM METALLICUM, MIMULUS GUTTATUS, FLOS, NITRICUM ACIDUM, RHUS AROMATICA, SILICEA, ULEX EUROPAEUS, FLOS, BENZOICUM ACIDUM, COBALTUM METALLICUM	Deseret Biologicals, Inc.	4f82e261-6101-48ab-b161-ded5aa41cd85	2023-06-27	Warnings	Exact identifier unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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