fluoxetine

Generic: fluoxetine

Labeler: torrent pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluoxetine
Generic Name fluoxetine
Labeler torrent pharmaceuticals limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

fluoxetine hydrochloride 10 mg/1

Manufacturer
Torrent Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 13668-443
Product ID 13668-443_f8d8c930-c8f9-4186-92fa-6f7a5dabe083
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206937
Listing Expiration 2026-12-31
Marketing Start 2016-10-21

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 13668443
Hyphenated Format 13668-443

Supplemental Identifiers

RxCUI
2532159 2532163
UPC
0313668443301 0313668473308
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 (source: ndc)
Generic Name fluoxetine (source: ndc)
Application Number ANDA206937 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (13668-443-01)
  • 1000 TABLET in 1 BOTTLE (13668-443-10)
  • 30 TABLET in 1 BOTTLE (13668-443-30)
  • 100 TABLET in 1 CARTON (13668-443-74)
  • 28 TABLET in 1 CARTON (13668-443-91)
source: ndc

Packages (5)

13668-443-01 100 TABLET in 1 BOTTLE (13668-443-01) 13668-443-10 1000 TABLET in 1 BOTTLE (13668-443-10) 13668-443-30 30 TABLET in 1 BOTTLE (13668-443-30) 13668-443-74 100 TABLET in 1 CARTON (13668-443-74) 13668-443-91 28 TABLET in 1 CARTON (13668-443-91)

Ingredients (1)

fluoxetine hydrochloride (10 mg/1)

Linked Drug Pages (1)

Fluoxetine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "f8d8c930-c8f9-4186-92fa-6f7a5dabe083", "openfda": {"upc": ["0313668443301", "0313668473308"], "unii": ["I9W7N6B1KJ"], "rxcui": ["2532159", "2532163"], "spl_set_id": ["dcebc7cf-6f95-4f7a-a22b-c7d2e0f04d74"], "manufacturer_name": ["Torrent Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (13668-443-01)", "package_ndc": "13668-443-01", "marketing_start_date": "20161021"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (13668-443-10)", "package_ndc": "13668-443-10", "marketing_start_date": "20161021"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (13668-443-30)", "package_ndc": "13668-443-30", "marketing_start_date": "20161021"}, {"sample": false, "description": "100 TABLET in 1 CARTON (13668-443-74)", "package_ndc": "13668-443-74", "marketing_start_date": "20161021"}, {"sample": false, "description": "28 TABLET in 1 CARTON (13668-443-91)", "package_ndc": "13668-443-91", "marketing_start_date": "20161021"}], "brand_name": "Fluoxetine", "product_id": "13668-443_f8d8c930-c8f9-4186-92fa-6f7a5dabe083", "dosage_form": "TABLET", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "13668-443", "generic_name": "Fluoxetine", "labeler_name": "Torrent Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluoxetine", "active_ingredients": [{"name": "FLUOXETINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA206937", "marketing_category": "ANDA", "marketing_start_date": "20161021", "listing_expiration_date": "20261231"}