fluoxetine hcl

Generic: fluoxetine hcl

Labeler: strides pharma science limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluoxetine hcl
Generic Name fluoxetine hcl
Labeler strides pharma science limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

fluoxetine 60 mg/1

Manufacturer
Strides Pharma Science Limited

Identifiers & Regulatory

Product NDC 64380-900
Product ID 64380-900_adcbffe8-9a0c-421a-9a18-21faac0207eb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212683
Listing Expiration 2027-12-31
Marketing Start 2024-11-08

Pharmacologic Class

Established (EPC)
serotonin reuptake inhibitor [epc]
Mechanism of Action
serotonin uptake inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64380900
Hyphenated Format 64380-900

Supplemental Identifiers

RxCUI
1190110
UPC
0364380900047
UNII
01K63SUP8D
NUI
N0000175696 N0000000109

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 hcl (source: ndc)
Generic Name fluoxetine hcl (source: ndc)
Application Number ANDA212683 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (64380-900-04)
source: ndc

Packages (1)

64380-900-04 30 TABLET in 1 BOTTLE (64380-900-04)

Ingredients (1)

fluoxetine (60 mg/1)

Linked Drug Pages (1)

FLUOXETINE HCL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "adcbffe8-9a0c-421a-9a18-21faac0207eb", "openfda": {"nui": ["N0000175696", "N0000000109"], "upc": ["0364380900047"], "unii": ["01K63SUP8D"], "rxcui": ["1190110"], "spl_set_id": ["d09a5026-b3eb-403f-bf31-d5991a81a8ce"], "pharm_class_epc": ["Serotonin Reuptake Inhibitor [EPC]"], "pharm_class_moa": ["Serotonin Uptake Inhibitors [MoA]"], "manufacturer_name": ["Strides Pharma Science Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (64380-900-04)", "package_ndc": "64380-900-04", "marketing_start_date": "20241108"}], "brand_name": "FLUOXETINE HCL", "product_id": "64380-900_adcbffe8-9a0c-421a-9a18-21faac0207eb", "dosage_form": "TABLET", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "64380-900", "generic_name": "fluoxetine hcl", "labeler_name": "Strides Pharma Science Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FLUOXETINE HCL", "active_ingredients": [{"name": "FLUOXETINE", "strength": "60 mg/1"}], "application_number": "ANDA212683", "marketing_category": "ANDA", "marketing_start_date": "20241108", "listing_expiration_date": "20271231"}