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 10 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 63187-081
Product ID 63187-081_27cdbe64-490e-4b1d-85da-f4a72a883098
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078619
Listing Expiration 2026-12-31
Marketing Start 2008-01-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63187081
Hyphenated Format 63187-081

Supplemental Identifiers

RxCUI
310384 310385
UPC
0363187069308 0363187081300
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 ANDA078619 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (63187-081-30)
  • 60 CAPSULE in 1 BOTTLE (63187-081-60)
  • 90 CAPSULE in 1 BOTTLE (63187-081-90)
source: ndc

Packages (3)

63187-081-30 30 CAPSULE in 1 BOTTLE (63187-081-30) 63187-081-60 60 CAPSULE in 1 BOTTLE (63187-081-60) 63187-081-90 90 CAPSULE in 1 BOTTLE (63187-081-90)

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": "27cdbe64-490e-4b1d-85da-f4a72a883098", "openfda": {"upc": ["0363187069308", "0363187081300"], "unii": ["I9W7N6B1KJ"], "rxcui": ["310384", "310385"], "spl_set_id": ["70e115cc-6e9b-4b96-a1a9-779ed51ad0a7"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (63187-081-30)", "package_ndc": "63187-081-30", "marketing_start_date": "20140430"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (63187-081-60)", "package_ndc": "63187-081-60", "marketing_start_date": "20140430"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (63187-081-90)", "package_ndc": "63187-081-90", "marketing_start_date": "20140430"}], "brand_name": "Fluoxetine", "product_id": "63187-081_27cdbe64-490e-4b1d-85da-f4a72a883098", "dosage_form": "CAPSULE", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "63187-081", "generic_name": "Fluoxetine Hydrochloride", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluoxetine", "active_ingredients": [{"name": "FLUOXETINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA078619", "marketing_category": "ANDA", "marketing_start_date": "20080131", "listing_expiration_date": "20261231"}