fluoxetine

Generic: fluoxetine

Labeler: legacy pharmaceutical packaging, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluoxetine
Generic Name fluoxetine
Labeler legacy pharmaceutical packaging, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

fluoxetine hydrochloride 10 mg/1

Manufacturer
Legacy Pharmaceutical Packaging, LLC

Identifiers & Regulatory

Product NDC 68645-131
Product ID 68645-131_4c222d2c-813c-5520-e063-6294a90affe6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076001
Listing Expiration 2027-12-31
Marketing Start 2011-01-25

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68645131
Hyphenated Format 68645-131

Supplemental Identifiers

RxCUI
310384 310385
UPC
0368645130545
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 (source: ndc)
Application Number ANDA076001 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (68645-131-54)
source: ndc

Packages (1)

68645-131-54 30 CAPSULE in 1 BOTTLE (68645-131-54)

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": "4c222d2c-813c-5520-e063-6294a90affe6", "openfda": {"upc": ["0368645130545"], "unii": ["I9W7N6B1KJ"], "rxcui": ["310384", "310385"], "spl_set_id": ["b07f9eab-44ac-4667-bd46-52d736daa5d6"], "manufacturer_name": ["Legacy Pharmaceutical Packaging, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (68645-131-54)", "package_ndc": "68645-131-54", "marketing_start_date": "20110125"}], "brand_name": "Fluoxetine", "product_id": "68645-131_4c222d2c-813c-5520-e063-6294a90affe6", "dosage_form": "CAPSULE", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "68645-131", "generic_name": "Fluoxetine", "labeler_name": "Legacy Pharmaceutical Packaging, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluoxetine", "active_ingredients": [{"name": "FLUOXETINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA076001", "marketing_category": "ANDA", "marketing_start_date": "20110125", "listing_expiration_date": "20271231"}