fluoxetine

Generic: fluoxetine

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

Drug Facts

Product Profile

Brand Name fluoxetine
Generic Name fluoxetine
Labeler cadila pharmaceuticals limited
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

fluoxetine hydrochloride 20 mg/1

Manufacturer
Cadila Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 71209-041
Product ID 71209-041_1922c101-5662-4952-9ac2-6470bbfd5ad3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206993
Listing Expiration 2026-12-31
Marketing Start 2022-12-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71209041
Hyphenated Format 71209-041

Supplemental Identifiers

RxCUI
310384 310385 313989
UPC
0371209041119 0371209040013 0371209042109 0371209042055 0371209041010 0371209040051 0371209041058 0371209042017
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 ANDA206993 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (71209-041-01)
  • 100 CAPSULE in 1 BOTTLE (71209-041-05)
  • 500 CAPSULE in 1 BOTTLE (71209-041-10)
  • 1000 CAPSULE in 1 BOTTLE (71209-041-11)
source: ndc

Packages (4)

71209-041-01 30 CAPSULE in 1 BOTTLE (71209-041-01) 71209-041-05 100 CAPSULE in 1 BOTTLE (71209-041-05) 71209-041-10 500 CAPSULE in 1 BOTTLE (71209-041-10) 71209-041-11 1000 CAPSULE in 1 BOTTLE (71209-041-11)

Ingredients (1)

fluoxetine hydrochloride (20 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": "1922c101-5662-4952-9ac2-6470bbfd5ad3", "openfda": {"upc": ["0371209041119", "0371209040013", "0371209042109", "0371209042055", "0371209041010", "0371209040051", "0371209041058", "0371209042017"], "unii": ["I9W7N6B1KJ"], "rxcui": ["310384", "310385", "313989"], "spl_set_id": ["9651816f-58f5-4bf8-8183-6f3d84d36b5c"], "manufacturer_name": ["Cadila Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (71209-041-01)", "package_ndc": "71209-041-01", "marketing_start_date": "20221215"}, {"sample": false, "description": "100 CAPSULE in 1 BOTTLE (71209-041-05)", "package_ndc": "71209-041-05", "marketing_start_date": "20221215"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (71209-041-10)", "package_ndc": "71209-041-10", "marketing_start_date": "20221215"}, {"sample": false, "description": "1000 CAPSULE in 1 BOTTLE (71209-041-11)", "package_ndc": "71209-041-11", "marketing_start_date": "20221215"}], "brand_name": "Fluoxetine", "product_id": "71209-041_1922c101-5662-4952-9ac2-6470bbfd5ad3", "dosage_form": "CAPSULE", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "71209-041", "generic_name": "Fluoxetine", "labeler_name": "Cadila Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluoxetine", "active_ingredients": [{"name": "FLUOXETINE HYDROCHLORIDE", "strength": "20 mg/1"}], "application_number": "ANDA206993", "marketing_category": "ANDA", "marketing_start_date": "20221215", "listing_expiration_date": "20261231"}