fluoxetine

Generic: fluoxetine hydrochloride

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluoxetine
Generic Name fluoxetine hydrochloride
Labeler proficient rx lp
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

fluoxetine hydrochloride 20 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 71205-975
Product ID 71205-975_14464dfb-94a5-43a1-923e-d462b7ade131
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204597
Listing Expiration 2026-12-31
Marketing Start 2019-09-25

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71205975
Hyphenated Format 71205-975

Supplemental Identifiers

RxCUI
310384 310385 313989
UPC
0371205979720 0371205974305 0371205975302
UNII
I9W7N6B1KJ

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 hydrochloride (source: ndc)
Application Number ANDA204597 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (71205-975-00)
  • 1000 CAPSULE in 1 BOTTLE (71205-975-11)
  • 30 CAPSULE in 1 BOTTLE (71205-975-30)
  • 500 CAPSULE in 1 BOTTLE (71205-975-55)
  • 60 CAPSULE in 1 BOTTLE (71205-975-60)
  • 120 CAPSULE in 1 BOTTLE (71205-975-72)
  • 90 CAPSULE in 1 BOTTLE (71205-975-90)
source: ndc

Packages (7)

71205-975-00 100 CAPSULE in 1 BOTTLE (71205-975-00) 71205-975-11 1000 CAPSULE in 1 BOTTLE (71205-975-11) 71205-975-30 30 CAPSULE in 1 BOTTLE (71205-975-30) 71205-975-55 500 CAPSULE in 1 BOTTLE (71205-975-55) 71205-975-60 60 CAPSULE in 1 BOTTLE (71205-975-60) 71205-975-72 120 CAPSULE in 1 BOTTLE (71205-975-72) 71205-975-90 90 CAPSULE in 1 BOTTLE (71205-975-90)

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": "14464dfb-94a5-43a1-923e-d462b7ade131", "openfda": {"upc": ["0371205979720", "0371205974305", "0371205975302"], "unii": ["I9W7N6B1KJ"], "rxcui": ["310384", "310385", "313989"], "spl_set_id": ["57f21f2b-0ec2-49dc-911a-806e5ae880c2"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (71205-975-00)", "package_ndc": "71205-975-00", "marketing_start_date": "20200507"}, {"sample": false, "description": "1000 CAPSULE in 1 BOTTLE (71205-975-11)", "package_ndc": "71205-975-11", "marketing_start_date": "20200507"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (71205-975-30)", "package_ndc": "71205-975-30", "marketing_start_date": "20200507"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (71205-975-55)", "package_ndc": "71205-975-55", "marketing_start_date": "20200507"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (71205-975-60)", "package_ndc": "71205-975-60", "marketing_start_date": "20200507"}, {"sample": false, "description": "120 CAPSULE in 1 BOTTLE (71205-975-72)", "package_ndc": "71205-975-72", "marketing_start_date": "20200507"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (71205-975-90)", "package_ndc": "71205-975-90", "marketing_start_date": "20200507"}], "brand_name": "Fluoxetine", "product_id": "71205-975_14464dfb-94a5-43a1-923e-d462b7ade131", "dosage_form": "CAPSULE", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "71205-975", "generic_name": "Fluoxetine Hydrochloride", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluoxetine", "active_ingredients": [{"name": "FLUOXETINE HYDROCHLORIDE", "strength": "20 mg/1"}], "application_number": "ANDA204597", "marketing_category": "ANDA", "marketing_start_date": "20190925", "listing_expiration_date": "20261231"}