Fluoxetine Hydrochloride

Product NDC: 47781-600
11-digit product format: 477810600
Labeler code: 47781
Product ID: 47781-600_d9d75587-0e5a-82e5-c7f0-ef5d9d854115
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluoxetine Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Alvogen Inc.
Application: NDA202133
Marketing category: NDA
Marketing start: 2017-09-01
Marketing end: 0000-00-00
Substance: FLUOXETINE HYDROCHLORIDE
Active strength: 60 mg/1
Pharmacologic classes: Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
47781-600-30	2024-01-30	C162847	48780-1	1030e365-018a-111a-e063-dadaa90a10e2	68d5f521-7e47-0c04-2cd0-b7d997e6fc84

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
47781-600-30	EA - Each	47781-600	d3288898-0844-4515-bb9f-30def92c685b	1	2017-12-14

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
I9W7N6B1KJ	FLUOXETINE HYDROCHLORIDE	56296-78-7	FLUOXETINE HYDROCHLORIDE

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
47781-600-30	47781060030	30 TABLET, FILM COATED in 1 BOTTLE (47781-600-30)	2017-09-01	0000-00-00	No	No	Current