Fluoxetine

Product NDC: 45865-378
11-digit product format: 458650378
Labeler code: 45865
Product ID: 45865-378_7df05c31-3cfa-f983-e053-2991aa0ad0e8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluoxetine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: medsource pharmaceuticals
Application: ANDA076006
Marketing category: ANDA
Marketing start: 2016-09-30
Marketing end: 0000-00-00
Substance: FLUOXETINE HYDROCHLORIDE
Active strength: 10 mg/1
Pharmacologic classes: Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2019-12-31
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ce7d40ce-bfb8-ee15-a060-423ec90d7ac9	Product name	6	20250331
e5b459e3-ddce-4802-aab4-2c901d71ae85	Product name	5	20250129
6d3d5b3a-d6b8-8417-8428-6414b08f1464	Product name	3	20240130
e7177a8f-11de-ee90-ca22-068e6ef54cf5	Product name	4	20230104
82da1192-6e97-fa73-2f85-6a50c10b4704	Product name	3	20161212
877783eb-030c-6e3f-0979-804cf94d8856	Product name	1	20140508

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
45865-378-60	2020-01-31	C162847	48780-1	9d75b9d0-a15f-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use FLUOXETINE TABLETS safely and effectively. See full prescribing information for FLUOXETINE TABLETS. FLUOXETINE tablets, for oral use Initial U.S. Approval : 1987

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
45865-378-60	Fluoxetine	60 in 1 BOTTLE	TABLET, FILM COATED	60		2

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45865-378	FLUOXETINE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	2	Legacy NDC, 1 package rows	20181227_7df05c31-3cf9-f983-e053-2991aa0ad0e8.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
I9W7N6B1KJ	FLUOXETINE HYDROCHLORIDE	56296-78-7	FLUOXETINE HYDROCHLORIDE
01K63SUP8D	FLUOXETINE	54910-89-3	Fluoxetine

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
313990	FLUoxetine HCl 10 MG Oral Tablet	PSN	7df05c31-3cf9-f983-e053-2991aa0ad0e8	2
313990	fluoxetine 10 MG Oral Tablet	SCD	7df05c31-3cf9-f983-e053-2991aa0ad0e8	2
313990	fluoxetine 10 MG (as fluoxetine hydrochloride 11.2 MG) Oral Tablet	SY	7df05c31-3cf9-f983-e053-2991aa0ad0e8	2

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
45865-378-60	45865037860	60 in 1 BOTTLE	Historical