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 137 of 137 · 2,726 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Teething	ARNICA MONTANA, TRIFOLIUM PRATENSE, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CHAMOMILLA, KREOSOTUM, SILICEA	BioActive Nutritional, Inc.	f39c9feb-f567-43a2-a026-2a581aeeed9d	2016-07-27	Warnings	Exact identifier unii: ETJ7Z6XBU4
Meijer Kids Tear Free SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	Meijer Distribution, Inc.	7415511e-1ecf-4646-b64b-267fbf7d116b	2016-06-02	Warnings	Exact identifier unii: 15FIX9V2JP
Meijer Baby Tear Free SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	Meijer Distributing Inc.	2434de23-bcc9-4a83-9945-16fc3f2b8c61	2016-06-01	Warnings	Exact identifier unii: 15FIX9V2JP
TOTAL DEFENSE REPAIR BROAD SPECTRUM SPF 34 Sunscreen (Tinted)	OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE AND ZINC OXIDE	Allergan, Inc.	6a996e03-907f-4e6a-b232-0892b86956b0	2015-08-21	Warnings	Exact identifier unii: 15FIX9V2JP
Renewal Firming Day Broad Spectrum SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	BURT'S BEES, INC.	18ceb5d8-4b76-6a54-e054-00144ff88e88	2015-06-18	Warnings	Exact identifier unii: 15FIX9V2JP
TiZO2	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, LTD.	30468afc-9616-4765-b046-12e97a0a7827	2010-12-20	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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