fluoxetine hydrochloride

Generic: fluoxetine hydrochloride

Labeler: dr.reddy's laboratories limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluoxetine hydrochloride
Generic Name fluoxetine hydrochloride
Labeler dr.reddy's laboratories limited
Dosage Form CAPSULE, DELAYED RELEASE PELLETS
Routes
ORAL
Active Ingredients

fluoxetine hydrochloride 90 mg/1

Manufacturer
Dr.Reddy's Laboratories Limited

Identifiers & Regulatory

Product NDC 55111-284
Product ID 55111-284_69d11d5f-adf1-142a-b4e2-1bace590eba8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078572
Listing Expiration 2026-12-31
Marketing Start 2010-03-24

Pharmacologic Class

Classes
serotonin reuptake inhibitor [epc] serotonin uptake inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55111284
Hyphenated Format 55111-284

Supplemental Identifiers

RxCUI
313995
UNII
I9W7N6B1KJ

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name fluoxetine hydrochloride (source: ndc)
Generic Name fluoxetine hydrochloride (source: ndc)
Application Number ANDA078572 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 90 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (55111-284-48) / 4 CAPSULE, DELAYED RELEASE PELLETS in 1 BLISTER PACK
source: ndc

Packages (1)

55111-284-48 1 BLISTER PACK in 1 CARTON (55111-284-48) / 4 CAPSULE, DELAYED RELEASE PELLETS in 1 BLISTER PACK

Ingredients (1)

fluoxetine hydrochloride (90 mg/1)

Linked Drug Pages (1)

Fluoxetine hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "69d11d5f-adf1-142a-b4e2-1bace590eba8", "openfda": {"unii": ["I9W7N6B1KJ"], "rxcui": ["313995"], "spl_set_id": ["887fc670-db67-4cfe-967b-46b38375dae5"], "manufacturer_name": ["Dr.Reddy's Laboratories Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (55111-284-48)  / 4 CAPSULE, DELAYED RELEASE PELLETS in 1 BLISTER PACK", "package_ndc": "55111-284-48", "marketing_start_date": "20100324"}], "brand_name": "Fluoxetine hydrochloride", "product_id": "55111-284_69d11d5f-adf1-142a-b4e2-1bace590eba8", "dosage_form": "CAPSULE, DELAYED RELEASE PELLETS", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "55111-284", "generic_name": "Fluoxetine Hydrochloride", "labeler_name": "Dr.Reddy's Laboratories Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluoxetine hydrochloride", "active_ingredients": [{"name": "FLUOXETINE HYDROCHLORIDE", "strength": "90 mg/1"}], "application_number": "ANDA078572", "marketing_category": "ANDA", "marketing_start_date": "20100324", "listing_expiration_date": "20261231"}